Introduction
Bone marrow transplantation has contributed significantly to the treatment of life-threatening hematological and non-hematological disorders. Recently, high dose chemotherapy (HDCT) with autologous stem cell transplantation (auto-HSCT) was proposed as a new and promising therapy for multiple sclerosis (MS) patients [2, 5, 6, 11]. MS is a chronic inflammatory disorder of central nervous system (CNS), caused by autoimmune reactivity of T cells towards CNS myelin components. Although MS is a non-life-threatening disorder, its progression inevitably leads to impairment of motor function, sensitive disturbances and cognitive impairment in MS patients due to the immune-mediated demyelination and axon degeneration [10]. The clinical course of the disease is very heterogeneous; however, most of the patients experience “relapsing-remitting” disease initially, which is characterized by intermittent exacerbations followed by neurological recovery. This disease stage is usually followed by gradual neurological impairment, known as secondary progressive disease [12]. The neurological disability in MS patients is quantified according to the Expanded Disability Status Scale (EDSS) [9]. EDSS ranges from zero (no disability) to 10 (death related to neurological progression) with 0.5-step increments. EDSS steps from 1.0 to 4.5 refer to fully ambulatory MS patients, while patients with EDSS 7.0 are essentially restricted to a wheelchair.Conventional therapies do not provide satisfactory control of MS. Although results of preclinical studies suggest that allogenic transplantation may lead to the decreased incidence of relapses of autoimmune disease, in a clinical situation the toxicity of allogenic SCT results in the unacceptable rate of transplant-related mortality. Therefore, HDCT+auto-HSCT has been established as a therapeutic option for MS patients. Since 1995, several clinical studies have addressed the issue of feasibility and efficacy of HDCT+auto-HSCT in MS and a certain clinical benefit was shown [2, 8, 10, 11,13-17,19]. The majority of patients included in the above-mentioned studies were severely disabled with an average EDSS score of 6.5. The BEAM conditioning regimen is considered to be the most effective although it is accompanied with the risk of transplant-related mortality [4]. At the same time taking into account the information about the risk of transplant-related mortality and side effects of myeloablative conditioning regimens, the rationale to use non-myeloablative regimens sounds reasonable [1]. In this connection different centers have initiated studies comparing mуеlоаblаtivе and nоn-mуеlоаblаtivе approaches. Our preliminary data shows that a non-myeloablative regimen based on reduced intensity BEAM is both effective and safe [14, 15,21].
We report the clinical and patient-reported outcomes of HDCT+auto-HSCT with reduced dose conditioning regimen (nоn-mуеlоаblаtivе approach) in an MS patient with secondary progressive disease.
Patient Characteristics
The patient S., a 35-year-old male, was diagnosed with MS at the age of 32 in 2004 when he presented with retrobulbar right eye neuritis, decreased vision of the right eye and unsteadiness. MRI examination revealed multiple widespread lesions in the periventricular, subepindimar and subcortical area, and corpus callosum. The extended disability status score (EDSS) was 3.0. After the second relapse the diagnosis of relapsing-remitting type MS was made (2004). The patient was treated with steroids and plasmapheresis. Complete regression of symptoms was achieved. From 2004 to 2006, the patient developed progressive deterioration of neurological function; relapses were registered twice a year. From 2006 to 2007 steady disease progression with no evident relapses and the increase of disability (by 2 EDSS points) was observed. Steroids and plasmapheresis were ineffective. Results of an MRI revealed 48 lesions in the brain and 3 in the cervical section of the spinal cord; among them there were 22 Gd+ lesions in the brain and 1 in the spinal cord (Figure 1, (a)). The EDSS was upgraded to 5.0. Due to disease progression without relapses within a year and the increase of disability the diagnosis of secondary progressive type MS was made.
The patient was enrolled in the study, which was approved by the local IRB and the Ethical Committee.
Figure 1. MRI scans of patient S. before (a) and 3 months after HDCT+auto-HSCT (b).
a - Multiple Gd+ lesions in periventricular area and Gd + ring lesion in cerebellum
Treatment outcomes
Clinical and patient-reported outcomes were assessed at baseline, at discharge, and at 3, 6, 9, 12, and 18 months after transplantation. Neurological assessment included measuring the EDSS score and MRI examinations. Patient-reported outcomes included QoL and symptom assessment. QoL was assessed by generic QoL questionnaire SF-36 [7]. The integral QoL index (IQLI) was calculated as described previously [18]. QoL treatment response was evaluated by comparison of IQLI before and after treatment. The following grades of response were used: improvement, stabilization and worsening. Symptoms were assessed using Comprehensive Symptom Profile-MS-SF. Comprehensive Symptom Profile-MS-SF is a new symptom assessment tool developed to assess the severity of 22 symptoms which are common and most disturbing for MS patients. It consists of numerical analogous scales, scored from “0” (no symptom) to “10” (most expressed symptom). Applicability and satisfactory psychometric properties of the instrument have been tested in MS patients’ population. Symptom treatment response was evaluated by comparison of symptom severity before and after treatment. The following grades of response were used: improvement, stabilization and worsening.
Stem Cell Mobilization and Transplant Procedure
Mobilization of hematopoietic stem cells was conducted according to EBMT/EULAR guidelines [22]. Stem cells were mobilized with G-CSF at 10 µg/kg.b.wt. The “Hemonetics MCS” system was used for autologous stem cell apheresis. The grafts were not manipulated. Reduced BEAM conditioning regimen included: BCNU (300 mg/m2) on day -6, etoposide (75 mg/m2) from day -5 to day -2, cytarabine (100 mg/m2 bd) from day -5 to day -2, and melphalan (30 mg/m2) on day -1. It was followed by autologous hematopoietic stem cell transplantation (day 0). In vivo T-cell depletion was achieved through infusion of 30 mg/kg of horse anti-thymocyte globulin (ATGAM, PHARMACIA & UPJOHN COMPANY) on days 1 and 2. Five µg/kg s.c. of G-CSF were administered from day 3 post-infusion until granulocyte recovery. For infection prophylaxis oral ciprofloxacin, fluconazole, and acyclovir were given.
Results
Adverse events
Transplantation procedure was well tolerated by the patient. Mobilization was successful: 2.3 x106/kg CD34+ cells were collected. No major clinical adverse events were observed during this phase. Unmanipulated grafts were infused without complications. Engraftment was uneventful, and no signs of an engraftment syndrome were reported. Neutropenia (grade IV) with PMN 0.09x109 was registered from D+4 to D+9; and thrombocytopenia with Plt 10x109 from D+4 to D+11. Neutropenic fever without infection was observed at D+7.
Clinical and patient reported outcomes
As a result of HDCT+auto-HSCT, disease improvement was registered. EDSS score dropped by 1.0 point (from 5.0 to 4.0) by 3 months post-transplant and remained stable throughout the time of follow-up (18 months) (Figure 2). The results of MRI scans 3 months after HDCT+auto-HSCT revealed a decrease in the number and the size of lesions. All 23 Gd+ lesions (22 brain and 1 spinal cord) turned to an inactive status (Figure 1, (b)). The MRI scans remained inactive at the end of follow-up (18 months post-transplant).
Figure 1. MRI scans of patient S. before (a) and 3 months after HDCT+auto-HSCT (b).
b - No Gd+ lesion
Significant QoL improvement was observed after HDCT+auto-HSCT. The IQLI increased from 0.33 at base-line to 0.50 at discharge. Further improvement of QoL parameters took place during follow-up: IQLI achieved 0.70 at 18 months post-transplant (Figure 2). It is worth mentioning that before transplantation IQLI was much lower than the corresponding value of the population norm adjusted to age and gender (IQLI mean in the sample of 35–39 year old males from general population is 0.49). After transplantation IQLI of patient S. achieved and then exceeded the corresponding value of the population norm. Thus, QoL treatment response is considered as improvement.
Figure 2. EDSS and Integral Quality of Life Index dynamics in patient S. before and after HDCT+auto-HSC.
Exceptional decrease of symptom severity after HDCT+auto-HSCT was registered. Before HDCT+auto-HSCT patient S. experienced 14 symptoms. The majority of these symptoms (9 out of 14) were moderate-to-severe (5–10 on numerical rating scale): fatigue, unsteadiness, vision disturbances, urination disturbances, speech disturbances, memory loss, decrease of attention concentration, poor heat tolerance and chill. Other symptoms: coordination problems, tremor, movement disturbances, and sexual problems were mild (1–4 on the numerical rating scale). The severity of moderate-to-severe symptoms of patient S. before transplantation and at different time-points post-transplant is presented in figure 3. In a year after transplantation the severity of these symptoms decreased significantly. Among the symptoms which were moderate-to-severe at base-line it is worth mentioning the decrease of severity of the following symptoms: fatigue (5 vs 0), unsteadiness (8 vs 1), vision disturbances (8 vs 4), urination disturbances (5 vs 2), speech disturbances (5 vs 2), memory loss (8 vs 1), decrease of attention concentration (8 vs 1), poor heat tolerance (10 vs 1), and chill (7 vs 1). Thus, symptom treatment response was achieved.
The patient received no treatment during the follow-up period post HDCT+ auto-HSCT.
Figure 3. Symptom severity in patient S. at different time-points after HDCT+auto-HSCT.
Discussion
During the last decade HDCT+autoHSCT has been used as a therapeutic option for MS patients. It is important to emphasize that there are two goals of treatment in MS patients. The first one is pathogenetic, which is to stop the disease progression and prevent the appearance of new lesions in the nervous tissue. The second, which is considered to be the final goal of a patient’s treatment, is to improve or maintain his QoL. Another important consideration is the necessity to search for optimal conditioning regimen, myeloablative or non-myeloablative, for HDCT+autoHSCT in MS. Taking into account the toxicity of myeloablative conditioning regimens, the rationale of using the non-myeloablative approach sounds reasonable. Therefore, auto-HSCT with reduced dose intensity BEAM was performed for this secondary progressive MS patient. In this case study we report effects of reduced dose intensity BEAM with auto-HSCT on the clinical course of the disease and patient-reported outcomes.
To our knowledge, this is the first case report to analyze clinical response, QoL treatment response and symptom treatment response in a MS patient after HDCT+auto-HSCT. Notably, the patient had a relatively low EDSS score as compared with patients included in the previous studies [4, 17]. As a result, clinical response was achieved both in terms of reduction of disability and disease activity. After transplantation EDSS decreased and all Gd+ lesions turned to an inactive status. HDCT+autoHSCT resulted in a QoL treatment response and symptom treatment response. The patient was off all therapy throughout the post transplant period.
Notably, his good response to this therapy might be explained by a relatively low EDSS score at base-line. Considering the pivotal role of autoreactive T-cells in MS pathogenesis, their eradication has to be a primary objective of MS treatment. This is achieved through ablation of the patient’s immune system with HDCT. HDCT is followed by auto-HSCT to restore an immune system that is expected to become tolerant to autoantigens. However, such “resetting” of the immune system is effective at early stages of MS only. Later in the clinical course of the disease, processes of axonal degeneration are prevailing and the damage to CNS tissue is too significant to expect a neurological recovery after HDCT+auto-HSCT. Indeed, failure of HDCT+auto-HSCT to prevent progression of the disease when performed on its late stages was shown in both animal models [3] and in recent clinical studies [11, 14]. Our findings corroborate these data, since patients who benefited from HDCT+auto-HSCT had had a low disability score.
Finally, this case demonstrates that HDCT+auto-HSCT may be an effective treatment for MS in terms of clinical and patient-reported outcomes. Use of a reduced dose intensity conditioning regimen resulted in clinical treatment response along with QoL treatment response and symptom treatment response. Complex evaluation of QoL treatment response and symptom treatment response along with neurological and MRI data is a convenient method of assessment of treatment outcomes in such heterogeneous group as MS patient population. Further studies should be done to investigate long-term effects of HDCT+auto-HSCT in MS patients for better definition of a treatment success.
References
1. Burt RK, Marmont A, Oyama Y, et al. Hematopoietic stem cell transplantation for progressive multiple sclerosis; failure of a total body irradiation-based conditioning regimen to preventRandomized controlled trials of autologous hematopoietic stem cell transplantat+ion for autoimmune diseases: the evolution from myeloablative to lymphoablative transplant regimens. Arthritis Rheum. 2006 Dec;54(12):3750-60.
4. Fassas A, Anagnostopoulos A, Kazis A, et al. Autologous stem cell transplantation in progressive multiple sclerosis – an interim analysis of efficacy. J Clin Immunol. 2000;20(1):24-30. doi: 10.1023/A:1006686426090.
5. Fassas A, Nash R. Multiple sclerosis. Best Pract Res Clin Hematol. 2004;17:247-262. doi: 10.1016/j.beha.2004.04.005.
7. Hays RD, Sherbourne CD, Mazel RM. User’s Manual for Medical Outcomes Study (MOS) Core measures of health-related quality of life. RAND Corporation, MR-162-RC (available at www.rand.org).
9. Kurtzke JF. Rating neurologic impairment in multiple sclerosis; an expanded disability status scale (EDSS). Neurology. 1983;33:1444-52. pmid: 6685237.
10. Muraro PA, McFarland HF, Martin R. Immunological aspects of multiple sclerosis with emphasis on the potential use of autologous hemopoietic stem cell transplantation. In: Burt RK, Marmont AM, eds. Stem Cell Therapy for Autoimmune Disease. Georgetown, TX: Landes Bioscience. 2004;277-283.
12. Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000;343:938-952. pmid: 11006371.
13. Novik A, Ionova T, Bisaga G, et.al. Clinical and Quality of Life Responses to High-Dose Chemotherapy plus Autologous Stem Cell Transplantation in Patients with Multiple Sclerosis: two case reports. Cytotherapy. 2005;7(4):363-367. doi: 10.1080/14653240500238194.
14. Novik A, Shevchenko Y, Kuznetsov A, et al. Autologous stem cell transplantation for multiple sclerosis patients: a 10-year experience of the Russian-American cooperation. Novik A, et al. Haematologica / The Hematology Journal. 2009;94(2):203.
15. Novik A, Kuznetsov A, Melnichenko V, et al. New non-myeloablative conditioning regimen for multiple sclerosis patients undergoing autologous hematopoietic stem cell transplantation. Multiple Sclerosis. 2008;14(1):169.
16. Openshaw H, Lund B, Kashyap A, et al. Peripheral blood stem cell transplantation in multiple sclerosis with busulfan and cyclophosphamide conditioning report of toxicity and immunological monitoring. Biology of Blood and Marrow Transplant. 2000;25:525-575.
18. Shevchenko YL, Novik AA, Ionova TI, et al. Three strategies of high dose chemotherapy + autologous stem cell transplantation in autoimmune diseases. Bone Marrow Transplant. 2004;33(1):346.
19. Shevchenko Y, Novik A, Ionova T, et al. Clinical and quality of life outcomes in patients with multiple sclerosis after high-dose chemotherapy + autologous stem cell transplantation [abstract no. 1875]. Blood. 2004;104:519a.
20. Shevchenko Y, Novik A, Ionova T, Kishtovich A. The method of integral profiles to study quality of life in rheumatoid arthritis patients. Bulletin of the Multinational Center of Quality of Life Research. 2004;3-4:11-8. Russian.
21. Shevchenko Y, Novik A, Kuznetsov A, et al. High-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation as a treatment option in multiple sclerosis. Experimental Hematology. 2008;36(8):922-929. doi: 10.1016/j.exphem.2008.03.001.
22. Tindall A, Gratwohl A. Blood and marrow stem cell transplants in autoimmune disease: A consensus report written on behalf of the European League against Rheumatism (EULAR) and the European Group for Blood and Marrow transplantation (EBMT). Bone Marrow Transplant. 1997;19:643-645.
" ["~DETAIL_TEXT"]=> string(22076) "Introduction
Bone marrow transplantation has contributed significantly to the treatment of life-threatening hematological and non-hematological disorders. Recently, high dose chemotherapy (HDCT) with autologous stem cell transplantation (auto-HSCT) was proposed as a new and promising therapy for multiple sclerosis (MS) patients [2, 5, 6, 11]. MS is a chronic inflammatory disorder of central nervous system (CNS), caused by autoimmune reactivity of T cells towards CNS myelin components. Although MS is a non-life-threatening disorder, its progression inevitably leads to impairment of motor function, sensitive disturbances and cognitive impairment in MS patients due to the immune-mediated demyelination and axon degeneration [10]. The clinical course of the disease is very heterogeneous; however, most of the patients experience “relapsing-remitting” disease initially, which is characterized by intermittent exacerbations followed by neurological recovery. This disease stage is usually followed by gradual neurological impairment, known as secondary progressive disease [12]. The neurological disability in MS patients is quantified according to the Expanded Disability Status Scale (EDSS) [9]. EDSS ranges from zero (no disability) to 10 (death related to neurological progression) with 0.5-step increments. EDSS steps from 1.0 to 4.5 refer to fully ambulatory MS patients, while patients with EDSS 7.0 are essentially restricted to a wheelchair.Conventional therapies do not provide satisfactory control of MS. Although results of preclinical studies suggest that allogenic transplantation may lead to the decreased incidence of relapses of autoimmune disease, in a clinical situation the toxicity of allogenic SCT results in the unacceptable rate of transplant-related mortality. Therefore, HDCT+auto-HSCT has been established as a therapeutic option for MS patients. Since 1995, several clinical studies have addressed the issue of feasibility and efficacy of HDCT+auto-HSCT in MS and a certain clinical benefit was shown [2, 8, 10, 11,13-17,19]. The majority of patients included in the above-mentioned studies were severely disabled with an average EDSS score of 6.5. The BEAM conditioning regimen is considered to be the most effective although it is accompanied with the risk of transplant-related mortality [4]. At the same time taking into account the information about the risk of transplant-related mortality and side effects of myeloablative conditioning regimens, the rationale to use non-myeloablative regimens sounds reasonable [1]. In this connection different centers have initiated studies comparing mуеlоаblаtivе and nоn-mуеlоаblаtivе approaches. Our preliminary data shows that a non-myeloablative regimen based on reduced intensity BEAM is both effective and safe [14, 15,21].
We report the clinical and patient-reported outcomes of HDCT+auto-HSCT with reduced dose conditioning regimen (nоn-mуеlоаblаtivе approach) in an MS patient with secondary progressive disease.
Patient Characteristics
The patient S., a 35-year-old male, was diagnosed with MS at the age of 32 in 2004 when he presented with retrobulbar right eye neuritis, decreased vision of the right eye and unsteadiness. MRI examination revealed multiple widespread lesions in the periventricular, subepindimar and subcortical area, and corpus callosum. The extended disability status score (EDSS) was 3.0. After the second relapse the diagnosis of relapsing-remitting type MS was made (2004). The patient was treated with steroids and plasmapheresis. Complete regression of symptoms was achieved. From 2004 to 2006, the patient developed progressive deterioration of neurological function; relapses were registered twice a year. From 2006 to 2007 steady disease progression with no evident relapses and the increase of disability (by 2 EDSS points) was observed. Steroids and plasmapheresis were ineffective. Results of an MRI revealed 48 lesions in the brain and 3 in the cervical section of the spinal cord; among them there were 22 Gd+ lesions in the brain and 1 in the spinal cord (Figure 1, (a)). The EDSS was upgraded to 5.0. Due to disease progression without relapses within a year and the increase of disability the diagnosis of secondary progressive type MS was made.
The patient was enrolled in the study, which was approved by the local IRB and the Ethical Committee.
Figure 1. MRI scans of patient S. before (a) and 3 months after HDCT+auto-HSCT (b).
a - Multiple Gd+ lesions in periventricular area and Gd + ring lesion in cerebellum
Treatment outcomes
Clinical and patient-reported outcomes were assessed at baseline, at discharge, and at 3, 6, 9, 12, and 18 months after transplantation. Neurological assessment included measuring the EDSS score and MRI examinations. Patient-reported outcomes included QoL and symptom assessment. QoL was assessed by generic QoL questionnaire SF-36 [7]. The integral QoL index (IQLI) was calculated as described previously [18]. QoL treatment response was evaluated by comparison of IQLI before and after treatment. The following grades of response were used: improvement, stabilization and worsening. Symptoms were assessed using Comprehensive Symptom Profile-MS-SF. Comprehensive Symptom Profile-MS-SF is a new symptom assessment tool developed to assess the severity of 22 symptoms which are common and most disturbing for MS patients. It consists of numerical analogous scales, scored from “0” (no symptom) to “10” (most expressed symptom). Applicability and satisfactory psychometric properties of the instrument have been tested in MS patients’ population. Symptom treatment response was evaluated by comparison of symptom severity before and after treatment. The following grades of response were used: improvement, stabilization and worsening.
Stem Cell Mobilization and Transplant Procedure
Mobilization of hematopoietic stem cells was conducted according to EBMT/EULAR guidelines [22]. Stem cells were mobilized with G-CSF at 10 µg/kg.b.wt. The “Hemonetics MCS” system was used for autologous stem cell apheresis. The grafts were not manipulated. Reduced BEAM conditioning regimen included: BCNU (300 mg/m2) on day -6, etoposide (75 mg/m2) from day -5 to day -2, cytarabine (100 mg/m2 bd) from day -5 to day -2, and melphalan (30 mg/m2) on day -1. It was followed by autologous hematopoietic stem cell transplantation (day 0). In vivo T-cell depletion was achieved through infusion of 30 mg/kg of horse anti-thymocyte globulin (ATGAM, PHARMACIA & UPJOHN COMPANY) on days 1 and 2. Five µg/kg s.c. of G-CSF were administered from day 3 post-infusion until granulocyte recovery. For infection prophylaxis oral ciprofloxacin, fluconazole, and acyclovir were given.
Results
Adverse events
Transplantation procedure was well tolerated by the patient. Mobilization was successful: 2.3 x106/kg CD34+ cells were collected. No major clinical adverse events were observed during this phase. Unmanipulated grafts were infused without complications. Engraftment was uneventful, and no signs of an engraftment syndrome were reported. Neutropenia (grade IV) with PMN 0.09x109 was registered from D+4 to D+9; and thrombocytopenia with Plt 10x109 from D+4 to D+11. Neutropenic fever without infection was observed at D+7.
Clinical and patient reported outcomes
As a result of HDCT+auto-HSCT, disease improvement was registered. EDSS score dropped by 1.0 point (from 5.0 to 4.0) by 3 months post-transplant and remained stable throughout the time of follow-up (18 months) (Figure 2). The results of MRI scans 3 months after HDCT+auto-HSCT revealed a decrease in the number and the size of lesions. All 23 Gd+ lesions (22 brain and 1 spinal cord) turned to an inactive status (Figure 1, (b)). The MRI scans remained inactive at the end of follow-up (18 months post-transplant).
Figure 1. MRI scans of patient S. before (a) and 3 months after HDCT+auto-HSCT (b).
b - No Gd+ lesion
Significant QoL improvement was observed after HDCT+auto-HSCT. The IQLI increased from 0.33 at base-line to 0.50 at discharge. Further improvement of QoL parameters took place during follow-up: IQLI achieved 0.70 at 18 months post-transplant (Figure 2). It is worth mentioning that before transplantation IQLI was much lower than the corresponding value of the population norm adjusted to age and gender (IQLI mean in the sample of 35–39 year old males from general population is 0.49). After transplantation IQLI of patient S. achieved and then exceeded the corresponding value of the population norm. Thus, QoL treatment response is considered as improvement.
Figure 2. EDSS and Integral Quality of Life Index dynamics in patient S. before and after HDCT+auto-HSC.
Exceptional decrease of symptom severity after HDCT+auto-HSCT was registered. Before HDCT+auto-HSCT patient S. experienced 14 symptoms. The majority of these symptoms (9 out of 14) were moderate-to-severe (5–10 on numerical rating scale): fatigue, unsteadiness, vision disturbances, urination disturbances, speech disturbances, memory loss, decrease of attention concentration, poor heat tolerance and chill. Other symptoms: coordination problems, tremor, movement disturbances, and sexual problems were mild (1–4 on the numerical rating scale). The severity of moderate-to-severe symptoms of patient S. before transplantation and at different time-points post-transplant is presented in figure 3. In a year after transplantation the severity of these symptoms decreased significantly. Among the symptoms which were moderate-to-severe at base-line it is worth mentioning the decrease of severity of the following symptoms: fatigue (5 vs 0), unsteadiness (8 vs 1), vision disturbances (8 vs 4), urination disturbances (5 vs 2), speech disturbances (5 vs 2), memory loss (8 vs 1), decrease of attention concentration (8 vs 1), poor heat tolerance (10 vs 1), and chill (7 vs 1). Thus, symptom treatment response was achieved.
The patient received no treatment during the follow-up period post HDCT+ auto-HSCT.
Figure 3. Symptom severity in patient S. at different time-points after HDCT+auto-HSCT.
Discussion
During the last decade HDCT+autoHSCT has been used as a therapeutic option for MS patients. It is important to emphasize that there are two goals of treatment in MS patients. The first one is pathogenetic, which is to stop the disease progression and prevent the appearance of new lesions in the nervous tissue. The second, which is considered to be the final goal of a patient’s treatment, is to improve or maintain his QoL. Another important consideration is the necessity to search for optimal conditioning regimen, myeloablative or non-myeloablative, for HDCT+autoHSCT in MS. Taking into account the toxicity of myeloablative conditioning regimens, the rationale of using the non-myeloablative approach sounds reasonable. Therefore, auto-HSCT with reduced dose intensity BEAM was performed for this secondary progressive MS patient. In this case study we report effects of reduced dose intensity BEAM with auto-HSCT on the clinical course of the disease and patient-reported outcomes.
To our knowledge, this is the first case report to analyze clinical response, QoL treatment response and symptom treatment response in a MS patient after HDCT+auto-HSCT. Notably, the patient had a relatively low EDSS score as compared with patients included in the previous studies [4, 17]. As a result, clinical response was achieved both in terms of reduction of disability and disease activity. After transplantation EDSS decreased and all Gd+ lesions turned to an inactive status. HDCT+autoHSCT resulted in a QoL treatment response and symptom treatment response. The patient was off all therapy throughout the post transplant period.
Notably, his good response to this therapy might be explained by a relatively low EDSS score at base-line. Considering the pivotal role of autoreactive T-cells in MS pathogenesis, their eradication has to be a primary objective of MS treatment. This is achieved through ablation of the patient’s immune system with HDCT. HDCT is followed by auto-HSCT to restore an immune system that is expected to become tolerant to autoantigens. However, such “resetting” of the immune system is effective at early stages of MS only. Later in the clinical course of the disease, processes of axonal degeneration are prevailing and the damage to CNS tissue is too significant to expect a neurological recovery after HDCT+auto-HSCT. Indeed, failure of HDCT+auto-HSCT to prevent progression of the disease when performed on its late stages was shown in both animal models [3] and in recent clinical studies [11, 14]. Our findings corroborate these data, since patients who benefited from HDCT+auto-HSCT had had a low disability score.
Finally, this case demonstrates that HDCT+auto-HSCT may be an effective treatment for MS in terms of clinical and patient-reported outcomes. Use of a reduced dose intensity conditioning regimen resulted in clinical treatment response along with QoL treatment response and symptom treatment response. Complex evaluation of QoL treatment response and symptom treatment response along with neurological and MRI data is a convenient method of assessment of treatment outcomes in such heterogeneous group as MS patient population. Further studies should be done to investigate long-term effects of HDCT+auto-HSCT in MS patients for better definition of a treatment success.
References
1. Burt RK, Marmont A, Oyama Y, et al. Hematopoietic stem cell transplantation for progressive multiple sclerosis; failure of a total body irradiation-based conditioning regimen to preventRandomized controlled trials of autologous hematopoietic stem cell transplantat+ion for autoimmune diseases: the evolution from myeloablative to lymphoablative transplant regimens. Arthritis Rheum. 2006 Dec;54(12):3750-60.
4. Fassas A, Anagnostopoulos A, Kazis A, et al. Autologous stem cell transplantation in progressive multiple sclerosis – an interim analysis of efficacy. J Clin Immunol. 2000;20(1):24-30. doi: 10.1023/A:1006686426090.
5. Fassas A, Nash R. Multiple sclerosis. Best Pract Res Clin Hematol. 2004;17:247-262. doi: 10.1016/j.beha.2004.04.005.
7. Hays RD, Sherbourne CD, Mazel RM. User’s Manual for Medical Outcomes Study (MOS) Core measures of health-related quality of life. RAND Corporation, MR-162-RC (available at www.rand.org).
9. Kurtzke JF. Rating neurologic impairment in multiple sclerosis; an expanded disability status scale (EDSS). Neurology. 1983;33:1444-52. pmid: 6685237.
10. Muraro PA, McFarland HF, Martin R. Immunological aspects of multiple sclerosis with emphasis on the potential use of autologous hemopoietic stem cell transplantation. In: Burt RK, Marmont AM, eds. Stem Cell Therapy for Autoimmune Disease. Georgetown, TX: Landes Bioscience. 2004;277-283.
12. Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000;343:938-952. pmid: 11006371.
13. Novik A, Ionova T, Bisaga G, et.al. Clinical and Quality of Life Responses to High-Dose Chemotherapy plus Autologous Stem Cell Transplantation in Patients with Multiple Sclerosis: two case reports. Cytotherapy. 2005;7(4):363-367. doi: 10.1080/14653240500238194.
14. Novik A, Shevchenko Y, Kuznetsov A, et al. Autologous stem cell transplantation for multiple sclerosis patients: a 10-year experience of the Russian-American cooperation. Novik A, et al. Haematologica / The Hematology Journal. 2009;94(2):203.
15. Novik A, Kuznetsov A, Melnichenko V, et al. New non-myeloablative conditioning regimen for multiple sclerosis patients undergoing autologous hematopoietic stem cell transplantation. Multiple Sclerosis. 2008;14(1):169.
16. Openshaw H, Lund B, Kashyap A, et al. Peripheral blood stem cell transplantation in multiple sclerosis with busulfan and cyclophosphamide conditioning report of toxicity and immunological monitoring. Biology of Blood and Marrow Transplant. 2000;25:525-575.
18. Shevchenko YL, Novik AA, Ionova TI, et al. Three strategies of high dose chemotherapy + autologous stem cell transplantation in autoimmune diseases. Bone Marrow Transplant. 2004;33(1):346.
19. Shevchenko Y, Novik A, Ionova T, et al. Clinical and quality of life outcomes in patients with multiple sclerosis after high-dose chemotherapy + autologous stem cell transplantation [abstract no. 1875]. Blood. 2004;104:519a.
20. Shevchenko Y, Novik A, Ionova T, Kishtovich A. The method of integral profiles to study quality of life in rheumatoid arthritis patients. Bulletin of the Multinational Center of Quality of Life Research. 2004;3-4:11-8. Russian.
21. Shevchenko Y, Novik A, Kuznetsov A, et al. High-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation as a treatment option in multiple sclerosis. Experimental Hematology. 2008;36(8):922-929. doi: 10.1016/j.exphem.2008.03.001.
22. Tindall A, Gratwohl A. Blood and marrow stem cell transplants in autoimmune disease: A consensus report written on behalf of the European League against Rheumatism (EULAR) and the European Group for Blood and Marrow transplantation (EBMT). Bone Marrow Transplant. 1997;19:643-645.
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За последние несколько лет высокодозная химиотерапия (ВДХТ) с аутологичной трансплантацией стволовых клеток (ауто-ТГСК) признана методом выбора в терапии больных рассеянным склерозом (РС). Мы сообщаем о клинических и субъективных результатах ВДХТ с ауто-ТГСК у мужчины со вторично-прогрессирующим РС (исходная оценка 5,0 по шкале EDSS). Применялся редуцированный режим кондиционирования по программе BEAM. В результате был достигнут клинический эффект в плане снижения уровня инвалидизации и активности заболевания, наряду с соответствующим изменением качества жизни (QoL) и симптоматики. В период после трансплантации больной не проходил иммуносупрессивного или иммуномодулирующего лечения. Наши результаты показывают, что ВДХТ с ауто-ТГСК может рассматриваться в качестве эффективного способа лечения больных РС с высокой активностью заболевания и относительно низкой степенью инвалидизации. Снижение дозной интенсивности при лечении, по-видимому, не влияет на исход терапии. Оценки показателей качества жизни и симптоматики представляются эффективным подходом к оценке исходов лечения больных РС.
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G.I. Gorodokin2
A.A. Novik1, A.N. Kuznetsov1, V.Y. Melnichenko1, D.A. Fedorenko1, T.I. Ionova1, R.V. Kruglina1, A.V. Kartashov1, K.A. Kurbatova1,
G.I. Gorodokin2
During the last several years high dose chemotherapy (HDCT) with autologous stem cell transplantation (auto-HSCT) has been established as a therapeutic option for multiple sclerosis (MS) patients. We report clinical and patient-reported outcomes of HDCT + auto-HSCT in a male patient affected by secondary progressive MS (EDSS 5.0 at base-line). Reduced BEAM conditioning regimen was used. As a result, clinical response in terms of reduction of disability and disease activity was achieved along with quality of life (QoL) treatment response and symptom treatment response. The patient was off immunosuppressive or immunomodulating therapy throughout the post-transplant period. Our findings demonstrate that HDCT+auto-HSCT might be considered as an effective treatment for MS patients with high disease activity and relatively low disability rate. Reduction of dose intensity seems to have no influence on treatment outcome. QoL and symptom measurement appears to be an effective approach to assessment of treatment outcomes in patients with MS.
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2New Jersey Center for Quality of Life and Health Outcome Research, USA
1Pirogov National Medical Surgical Center, the Department of Hematology and Cellular Therapy and the Department of Neurology, Pirogov National Medical Surgical Center, Moscow, Russia;
2New Jersey Center for Quality of Life and Health Outcome Research, USA
Новик А. А., Кузнецов А. Н., Мельниченко В. Я., Федоренко Д. А., Ионова Т. И., Круглина Р. В., Карташов А. В.,
Курбатова К. А., Городокин Г. И.
Новик А. А., Кузнецов А. Н., Мельниченко В. Я., Федоренко Д. А., Ионова Т. И., Круглина Р. В., Карташов А. В.,
Курбатова К. А., Городокин Г. И.
За последние несколько лет высокодозная химиотерапия (ВДХТ) с аутологичной трансплантацией стволовых клеток (ауто-ТГСК) признана методом выбора в терапии больных рассеянным склерозом (РС). Мы сообщаем о клинических и субъективных результатах ВДХТ с ауто-ТГСК у мужчины со вторично-прогрессирующим РС (исходная оценка 5,0 по шкале EDSS). Применялся редуцированный режим кондиционирования по программе BEAM. В результате был достигнут клинический эффект в плане снижения уровня инвалидизации и активности заболевания, наряду с соответствующим изменением качества жизни (QoL) и симптоматики. В период после трансплантации больной не проходил иммуносупрессивного или иммуномодулирующего лечения. Наши результаты показывают, что ВДХТ с ауто-ТГСК может рассматриваться в качестве эффективного способа лечения больных РС с высокой активностью заболевания и относительно низкой степенью инвалидизации. Снижение дозной интенсивности при лечении, по-видимому, не влияет на исход терапии. Оценки показателей качества жизни и симптоматики представляются эффективным подходом к оценке исходов лечения больных РС.
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Hematopoietic stem cell transplantation (HSCT) is one of the most efficient methods in the treatment of hematological and oncological disorders. Each year, some 25,000 autologous HSCTs (auto-HSCT) and 15,000 allogeneic HSCTs (allo-HSCT) from donors with different degrees of HLA compatibility (related, unrelated, and haploidentical donors) are performed worldwide.
In spite of the advances in the treatment of allo-HSCT, infectious complications, especially invasive fungal diseases (IFD) remain one of the main causes of high morbidity and mortality in the allo-HSCT recipients cohort [3], with one of the most significant factors being the difficultly of diagnosis in the early (up to 100 days from HSCT) and the late (more than 100 days) post-HSCT periods [17]. IFD develop in 5–18% of allo-HSCT recipients, while after auto-HSCT the incidence of fungal infections is much lower, i.e., 1.1% [4]. The overall mortality from IFD in the first year after diagnosis is 70–93%. Most are diagnosed postmortem.
The incidence of IFD is influenced by the HLA-compatibility between donor and recipient. In related allo-HSCT the incidence of IFD is 3.7%, and when the donor and recipient are partially matched it rises to 5.9% [6]. This distinction is caused by the profound and prolonged immunosuppression that is employed as “graft-versus-host” disease (GVHD) prophylaxis [7].
In the last few years allo-HSCT has become a treatment option for many more patients [8] due to the practical application of conditioning regimens with reduced intensity and toxicity [5], implementation of new immunosuppressive drugs, and more effective regimens of treatment for acute GVHD (aGVHD) and chronic GVHD (cGVHD) [8]. The treatment of IFD in patients with GVHD is complicated by the fact that in most clinical situations sufficient response to antifungal therapy can be achieved only by diminishing the intensity of immunosuppression [8], and this option is often unacceptable.
IFD has a different etiology and in general the incidence of IFD caused by mold fungi such as Aspergillus fumigatus, Fusarium species, and Zygomycetes species [4] has increased. This can be attributed not only to the actual increase in number of mold infections after allo-HSCT, but also to the development of better diagnostic tools [10].
In spite of this general increase of IFD, Zygomycetes spp. infection is diagnosed in less than 2% of the cases [11]. The incidence of invasive candidiasis has decreased from 77% to 42%, but at the same time invasive aspergillosis (IA) rates increased from 13% to 29% [4]. Currently, the most common etiological agents of invasive candidiasis are С. albicans, C. tropicalis, C. glabrata, C. parapsilosis and C. krusei.
In summary, infectious complications, along with relapses of the disease and GVHD, remain one of the most significant factors that determine the effectiveness of allo-HSCT in the treatment of hematologic, oncologic, and congenital diseases [1, 2].
Research purpose. To determine the etiology, incidence, and risk factors of IFD in patients suffering from different hematological diseases who underwent allo-HSCT (a single center experience).
Materials and methods
Between October 2000 and June 2008, 221 patients (pts) underwent allo-HSCT in the R. M. Gorbacheva Memorial Institute of Children Hematology and Transplantation (ICHT) (former BMT Clinic) of Saint Petersburg’s State Pavlov Medical University (SPbSMU). The age range of patients was from 1 to 66 years; 131 of the patients were younger than 21 years, and 90 of them were older than 21.
In most of the cases, if the family member was HLA-compatible, related allo-HSCT was performed. For the other patients an unrelated donor was searched for and activated in the international donor database. In the absence of fully-matched donors haploidentical HSCT (haplo-HSCT) was performed (usually from the patient’s mother). Overall, 135 pts underwent unrelated allo-HSCT, 77 pts related allo-HSCT, and 9 pts haplo-HSCT.
Allo-HSCT was performed in 91 pts with acute lymphoblastic leukemia (ALL), 57 pts with acute myeloid leukemia (AML), 2 pts with acute biphenotypic leukemia (BiAL), 25 pts with chronic myelo- and lymphoproliferative disorders (CMPD, CLPD), 1 pt with hypereosinophilic syndrome (HES), 11 pts with severe aplastic anemia (АА), 8 pts with congenital disorders, 5 pts with Hodgkin’s lymphoma (HL), 11 pts with non-Hodgkin’s lymphoma (NHL), 6 pts with myelodysplastic syndrome (MDS), 1 with primary myelofibrosis (MF), and 3 pts with solid tumors.
Allo-HSCT was performed in cases of remission (134 pts), and also in patients with relapse and progression (87 pts) of their disease (Table 1).
Table 1. Characteristics of the patients who underwent allo-HSCT
For 86 recipients (39%) myeloablative conditioning (MC) regimens were used, containing busulfan 16 mg/kg, and cyclophosphamide 120 mg/m2 [11]. Allo-HSCT in 135 pts (61%) was performed after a reduced-intensity conditioning (RIC) regimen of fludarabine 150 mg/m2, and busulfan 8 mg/kg or melphalan 140 mg/m2 [12].
In 67 pts the source of the hematopoietic stem cells (HSC) was bone marrow (BM), and in 142 pts peripheral blood stem cells (PBSC) were used. In 12 pts a combination of both sources were used due to insufficient СD34+/kg value after the first cell procurement. The total value of СD 34+/kg ranged from 3.0 to 8.0 х 10/6kg.
The EBMT criteria were used for the assessment of hematopoietic recovery after allo-HSCT: neutrophils at 0.5х109/l for at least 3 days without any granulocyte colony-stimulating factor (G-CSF) administration, trombocytes 20х109/l for at least 3 days without transfusions.
For aGVHD prophylaxis cyclosporine A at 3mg/kg from D-1 in combination with a short course of methotrexate 10 mg/m2 was given on D+1, +3 and +6, or, in other cases, mycophenolate mophetil (MMF) 30 mg/kg from D+1. Another regimen was the combination of tacrolimus 0.03 mg/kg from D-1 and MMF 30 mg/kg from D+1. Anti-thymocyte globulin (ATG) or alemtuzumab were added in unrelated allo-HSCT and haplo-HSCT, and quite rarely, related allo-HSCT cases.
Corticosteroids (1–3 mg/kg of prednisolone or methylprednisolone) with gradual tapering were used as the first line of treatment of aGVHD or cGVHD. For aGVHD with intestinal involvement, topical steroids (budesonide) were added to the therapy scheme at the rate of up to 9 mg/day. As a second line of immunosuppression TNF-б blockers (infliximab, etanercept), and IL-2 receptor blockers (daclizumab) were used; cGVHD was treated with anti-CD20 antibodies (rituximab). The grade of aGVHD and cGVHD were defined according to international criteria [16].
Patients’ examination before allo-HSCT and in the early post-transplant period
Pre-transplant examination of patients included serological screening for the following infections: cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus type 1 and 2 (HSV), and toxoplasmosis. Additionally, bacteriological and mycological studies (evaluation of blood, urine, stool and pharyngeal smear cultures) were performed on all patients.
In the early post-transplant period (up to D+100), the CMV status was monitored by PCR. Fungal infection monitoring was performed once a week by testing the galactomannan level via a latex-agglutination test (Enzyme-Linked Immunosorbent Assay, Platelia Aspergillus, Bio Rad) and, if the results were stable negative the test was performed bi-weekly. Early diagnostics of IM were performed using chest CT scans.
If any signs of infection were discovered, the microbiological, mycological (including galactomannan assay), and virological studies were repeated. To determine the localization of infection, chest X-ray or CT scan, abdominal US-scan, MRT or CT brain scans were performed.
In certain cases bronchoscopy with a study of bronchoalveolar lavage (BAL) cultures, or ophtalmoscopy with pupil dilatation were done.
Prophylaxis against infectious complications in allo-HSCT recipients
Allo-HSCT recipients were treated in wards with HEPA-filtered air. Selective decontamination was conducted from D-7 to D-1, then from D+1 up until recovery of granulocyte count of 0.5х109/l, and included the following antibacterial drugs: Ciprofloxacin 10 mg/kg/day, metronidazole 30 mg/kg/day; non-absorbing antibiotics per os (80 mg gentamycin 80 and 50000 units of amphotericin-B in form of water suspension).
All patients received trimethoprim/sulfametoxasol (5 mg/kg/day trimethoprim) as Pneumocystis carinii infection prophylaxis, which continued after engraftment until the completion of immunosuppressive therapy.
For herpes viral infection prophylaxis all patients received zovirax (5 mg/kg) from D-7 until D-1, then from D+1 until the end of immunosuppressive therapy.
Ganciclovir (5 mg/kg) was used for CMV infection prophylaxis in the patients with more than 103 copies by polymerase chain reaction (PCR).
The choice of antifungal drug for prophylaxis against IFD was based on anamnesis data on previous fungal infections, duration and severity of chemotherapy-induced neutropenia prior to allo-HSCT, and the type and stage of disease. Different generations of azoles were prescribed in 212 recipients test subject group: fluconazole (400 mg/day in adults, 6 mg/kg/day in children) in 155 pts, itraconazole (200 mg/day in adults, 8 mg/kg/day in children) in 19 pts, and voriconazole (6 mg/kg/day the 1st day, then 4 mg/kg/day in adults and 14 mg/kg/day in children) in 37 pts. For primary prophylaxis 4 pts received caspofungin (70 mg/kg/day the 1st day, then 50 mg/kg/day, no age adjustments were used). In one of the patients with resistant soft tissues IFD caused by a. flavus and a. fumigatus, caspofungin (70 mg/kg/day the 1st day, then 50 mg/kg/day) and posaconazole (800 mg/day) were given as secondary prophylaxis before haplo-HSCT.
Invasive fungal diseases was classified according to EORTC/MSG 2005 criteria based on host risk factors, clinical presentations, and infectious agent identification. The host risk factors considered were congenital immunodeficiency, immunosuppressive therapy by calcinerim inhibitors, long courses (more than 3 weeks) of steroids, prolonged (more than 10 days) neutropenia (ANC<0,5х109/l) and previous therapy with monoclonal antibodies (MABs), б-TNF inhibitors or antilymphocyte globulin. Fever was considered non-specific to fungal infections; it was regarded as a host factor. Based on these criteria, all IFD was divided into three forms: possible , probable , and proven. For verification of IFD (proven IFD) the fungal culture or a biopsy specimen with fungal mycelium visible by light microscopy had to be obtained from normally sterile tissue. Probable IFD was characterized by the presence of host factors, characteristic lesions on chest, brain or sinus CT scan, and/or characteristic changes discovered by abdominal US-scan or fundoscopy. For probable IFD the following criteria were used: fungal mycelium detectable by light microscopy in a normally non-sterile tissue specimen (sinus mucosa or BAL) and/or positive culture from sinus aspirate or BAL, positive Aspergillus antigen in blood, spinal fluid or BAL.
Possible IFD was characterized by the presence of host factors and characteristic clinical findings with no according laboratory confirmation [13].
Statistics
Fisher's exact test, the chi-quadrat test and the Mann-Whitney test were used for statistical data processing. Descriptive statistics methods were used for validation of continuous variables. Risks were calculated using likelihood ratios. Distinctions were considered reliable if error probability was below 0.05 (р≤0.05).
Results
Patients with possible, probable and proven IFD were included in the analysis. The occurrence of IFD between October 2000 and July 2008 amounted to 60/221 (27%) in the early post-allo-HSCT period and 8/221 (4%) in the late post-allo-HSCT period.
After allo- HSCT according to the EORTC/MSG definitions 2005 was diagnosed in 27 patients possible IFD, in 38 patients probable and in 3 patients proven (Fig.1).
Figure 1. IFD according to the EORTC/MSG definitions in patients after allo- HSCT
Probable aspergillosis involving the lungs was diagnosed in 32 pts; one patient had simultaneous lung and brain lesions, and lungs and sinus lesions occurred in 3pts. One post-haplo-HSCT patient had lung lesions caused by A. fumugatus and Cryptococcal CNS infection.
Possible aspergillosis with lung involvement was diagnosed in 24 pts; combined involvement of lungs and sinus in 3 pts.
Chronic disseminated candidiasis (CDC) was revealed in 2 pts, and C. krusei was detected in one patient. Candidemia was caused by C. parapsilosis in 3 pts.
In 25 pts IFD was diagnosed before allo-HSCT treatment. In all of these cases the necessary degree of infection control was obtained prior to allogeneic transplant procedure. IFD reactivation after allo-HSCT was noted in 10 of 25 (40%) pts.
The most common target organ of possible and probable IFD was the lung. Lung involvement was found in 51% of IFD patients younger than 21 (HR=10; 95% confidence range, 5.6–21.3 Р<0.05), and 49% of IFD patients older than 21 (HR=11; 95% confidence range, 5.6–21.3 Р<0.05). The other targeted organs were the sinuses: 6/68 (8%) of patients, and the brain: 2/68 (3%) of patients.
When looking at CT-scans results, specific lesions were revealed in 12 pts, in 32 cases signs of IFD were nonspecific, in 7 cases changes were not revealed; in 18 pts a CT-scan was not done. The ELISA-test was performed on 35pts only: galactomannan was positive in 27 pts and negative in 8 pts.
In the younger (≤21 years) patients, IFD was found in 12/43 (28%) pts after related allo-HSCT, in 28/80 (35%) pts after unrelated allo-HSCT, and in 3/8 (38%) pts after haplo-HSCT (Fig. 2).
Figure 2. Incidence of IFD after allo-HSCT in patients ≤21 years old
In older (>21 years) patients, IFD was found after related allo-HSCT in 7/34 (20%) pts and in 18/55 (33%) pts after unrelated allo-HSCT; the one patient who was treated with haplo-HSCT did not develop IFD (Fig. 3).
Figure 3. Incidence of IFD after allo-HSCT in patients >21 years old
In the case of younger patients (≤21 years) who were given RIC and allo-HSCT, IFD was diagnosed in 20/63 (32%) cases and in 4/23 (17%) pts in the older group (>21 years). IFD was diagnosed in 23/68 (34%) cases in the younger patients' group, and in 21/67 (31%) of older patients who were given MC. The median of IM diagnosis after allo-HSCT with RIC was at D+88 (day 13–740) and at D+ 86 (day 1–940) after allo-HSCT combined with MC.
The characteristics of patients with IFD are shown in tables 2 and 3.
Table 2. IFD characteristics in patients ≤21 years
Table 3. IM characteristics in patients >21 years
In allo-HSCT recipients >21 years old the incidence of IFD was 1.8-fold higher after allo-HSCT with RIC than in patients who had undergone an MC regimen (hazards ratio (HR)=1.2; 95% confidence range, 1.01–1.6, р<0.05). In the group of elder patients, the incidence of IM after related allo-HSCT was higher in patients given an RIC regimen in relapse (HR=0.5; 95% confidence range, 0.3–0.9, р <0.05).
Different grades of mucositis influence the frequency of IFD occurrence in both age groups (HR=2.1; 95% confidence range, 1.2–3.8, р<0.05 for patients ≤21 years; HR=2.1; 95% confidence range, 1.2–3.8, р<0.05 for patients >21 years).
When looking at the source of HSC, the following incidence rates of IFD were observed: for BM recipients ≤21 years it amounted to 12/43 (28%) pts; for the patients of the same age group that received PBSC it was 27/78 (35%). IFD was diagnosed in 4/10 (40%) pts that received HSC from a mixed (BM and PBSC) source. In the elder age group the incidence of IFD amounted to 4/24 (16%) of patients that received BM, 20/64 (31%) of PBSC recipients, and IFD developed in 1/2 (50%) patients who received cells from a mixed source. The comparison didn’t show up as statistically valid (p>0.05).
Multivariate analysis revealed the influence of the following risk factors on the probability of IFD development in younger (≤21 years) patients. These factors are allo-HSCT conducted in relapse, and the usage of RIC regimens before allo-HSCT with BM (HR=0.4; 95% confidence range, 0.21–0.76, р<0.05). The incidence of IFD was noticeably lower in the group of patients older than 21 who were transplanted in remission using a HLA-compatible related donor with MC where PBSC was the HSC source than in groups of patients with any other risk factors (HR=1.59; 95% confidence range, 1.01–2.51, р<0.05).
The introduction of ALG into the conditioning regimen for patients of the elder (>21 years) age group increased the possibility of IFD (HR=0.7; 95% confidence range, 0.59–0.88, р<0.05). In the younger (≤21 years) age group this difference was not statistically valid.
The rate of engraftment after allo-HSCT had no effect on the incidence and time of diagnosis of IFD in either age group. In patients ≤21 years the engraftment was noted on D+19±8 (from D+13 to D+46); in patients >21 years on D+16±4 (from D+9 to D+29) (р>0.05).
In patients ≤21 years with grade I–III aGVHD IFD developed in 17/66 (26%) cases; in 5/13 (46%) pts with grade IV aGVHD and 4/26 (15%) pts with an extensive form of cGVHD. In patients with an extensive form of cGVHD the incidence of IFD was significantly higher (HR= 2.1; 95% confidence range, 1.3–3.4, р<0.05). In patients >21 years IFD developed in 12/45 (27%) cases with grade I–III aGVHD, and in 2/11 (18%) pts with grade IV aGVHD. IFD also developed in 2/13 (15%) pts with extensive cGVHD following aGVHD.
In the elder (>21 years) group of patients the following incidence of IFD depending on antifungal prophylaxis was observed: under fluconazole in 29/94 (30%) pts, under itraconazole in 2/8 (25%) pts, under voriconazole in 13 of 25 (52%) pts; and no IFD developed in patients that received prophylaxis with caspofungine (2 pts) or posaconazole (1pt). For the younger group the IFD incidence under fluconazole was in 19 of 61 (31%) pts, under itraconazole in 2 of 11 (18%) pts, under voriconazole in 3 of 12 (25%) pts and no IFD cases emerged under prophylaxis with caspofungine (0/2). The difference of IFD incidence between these age groups had no statistical significance (p>0.05).
The 12-weeks overall survival (OS) after diagnosis of IFD in patients after allo-HSCT is 50%.
Figure 4. 12-weeks OS after diagnosis of IFD in patients after allo-HSCT
Log Rank <0.05
The influence of IFD on 5-year (OS) after allo-HSCT in both age groups was 40% (without IFD) and 18% (with IFD) (Fig.5).
Figure 5. 5-years OS in patients after allo-HSCT with and without IM
Conclusion
The incidence of IFD after allo-HSCT remains high. Depending on donor characteristics (HLA-matched related, unrelated or haploidentical donor) it is 28%, 35%, and 38% respectively.
Looking at age it is 32% for patients ≤21 years, and 27% for patients >21 years. The overall IFD incidence is slightly higher than in similar studies [15], but this may be explained by the characteristics of the groups analyzed. In our study 87/221 (39%) pts underwent allo-HSCT in relapse, and this proved to be a risk factor.
Despite the fact that age above 10 years was considered a risk factor for IFD development in both early and late periods after allo-HSCT [14], in this study the age was not an independent risk factor of IFD. In the RIC regimen group IFD was diagnosed in 34% of younger (≤21 years) patients and 31% of older (>21 years); and for the MC group it amounted to 32% for younger (p>0.05) and 17% for elder age groups (p<0.05). Neither the rate of IFD in both age groups, the source of HSC and/or rate of post-transplant engraftment were found to independently exert influence on the incidence of IFD following allo-SCT.
IFD incidence was 1.8-fold higher in elder relapsed patients after related allo-HSCT with RIC (p<0.05). Contrariwise, in this group the incidence of IFD was low in patients that underwent HSCT in remission and received PBSC (p<0.05). The possible reason for this could be the population structure of G-CSF-stimulated donor PBSC, which alleviates immune reconstitution [9]. The influence of transplant type was also noticed in the younger (≤21 years) group: the probability of IFD development was much higher in relapsed patients after BM allo-HSCT with RIC (p<0.05). It was noticed that the disease stage, grade I–IV mucositis (p<0.05), and extensive cGVHD (p<0.05) were the most prominent risk factors for IFD development. When these factors are present no difference was seen in groups with different conditioning regimens and HSC sources.
In patients >21 years IFD incidence increased by inclusion of ATG in the conditioning regimen (p<0.05). Agents such as ATG, steroid-depressed function of immunocompetent cells (macrophages, granulocytes, monocytes and T-cells) and decreased production and secretion of pro-inflammatory cytokines (TNF, IFN-г, IL-2) secretion [9].
Our study revealed that IFD impairs the OS in patients after allo-HSCT in both age groups, but especially in patients older than 21 years.
In conclusion, the main risk factors that influence the incidence of IFD after allo-HSCT in all age groups are the stage of the disease, mucositis development, and extensive form of cGVHD.
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15. Richardson MD. Changing patterns and trends in systemic fungal infections. Journal of Antimicrobial Chemotherapy. 2005;56(S):5-11.
16. Deeg HJ. How I treat refractory acute GVHD. Blood. 2007;109(10):4119-4126.
17. Garcia-Vidal C et al. Epidemiology of invasive mold infections in allogeneic stem cell transplant recipients: biological risk factors for infection according to time after transplantation. CID. 2008;47(8):1041-1050.
" ["~DETAIL_TEXT"]=> string(28769) "Introduction
Hematopoietic stem cell transplantation (HSCT) is one of the most efficient methods in the treatment of hematological and oncological disorders. Each year, some 25,000 autologous HSCTs (auto-HSCT) and 15,000 allogeneic HSCTs (allo-HSCT) from donors with different degrees of HLA compatibility (related, unrelated, and haploidentical donors) are performed worldwide.
In spite of the advances in the treatment of allo-HSCT, infectious complications, especially invasive fungal diseases (IFD) remain one of the main causes of high morbidity and mortality in the allo-HSCT recipients cohort [3], with one of the most significant factors being the difficultly of diagnosis in the early (up to 100 days from HSCT) and the late (more than 100 days) post-HSCT periods [17]. IFD develop in 5–18% of allo-HSCT recipients, while after auto-HSCT the incidence of fungal infections is much lower, i.e., 1.1% [4]. The overall mortality from IFD in the first year after diagnosis is 70–93%. Most are diagnosed postmortem.
The incidence of IFD is influenced by the HLA-compatibility between donor and recipient. In related allo-HSCT the incidence of IFD is 3.7%, and when the donor and recipient are partially matched it rises to 5.9% [6]. This distinction is caused by the profound and prolonged immunosuppression that is employed as “graft-versus-host” disease (GVHD) prophylaxis [7].
In the last few years allo-HSCT has become a treatment option for many more patients [8] due to the practical application of conditioning regimens with reduced intensity and toxicity [5], implementation of new immunosuppressive drugs, and more effective regimens of treatment for acute GVHD (aGVHD) and chronic GVHD (cGVHD) [8]. The treatment of IFD in patients with GVHD is complicated by the fact that in most clinical situations sufficient response to antifungal therapy can be achieved only by diminishing the intensity of immunosuppression [8], and this option is often unacceptable.
IFD has a different etiology and in general the incidence of IFD caused by mold fungi such as Aspergillus fumigatus, Fusarium species, and Zygomycetes species [4] has increased. This can be attributed not only to the actual increase in number of mold infections after allo-HSCT, but also to the development of better diagnostic tools [10].
In spite of this general increase of IFD, Zygomycetes spp. infection is diagnosed in less than 2% of the cases [11]. The incidence of invasive candidiasis has decreased from 77% to 42%, but at the same time invasive aspergillosis (IA) rates increased from 13% to 29% [4]. Currently, the most common etiological agents of invasive candidiasis are С. albicans, C. tropicalis, C. glabrata, C. parapsilosis and C. krusei.
In summary, infectious complications, along with relapses of the disease and GVHD, remain one of the most significant factors that determine the effectiveness of allo-HSCT in the treatment of hematologic, oncologic, and congenital diseases [1, 2].
Research purpose. To determine the etiology, incidence, and risk factors of IFD in patients suffering from different hematological diseases who underwent allo-HSCT (a single center experience).
Materials and methods
Between October 2000 and June 2008, 221 patients (pts) underwent allo-HSCT in the R. M. Gorbacheva Memorial Institute of Children Hematology and Transplantation (ICHT) (former BMT Clinic) of Saint Petersburg’s State Pavlov Medical University (SPbSMU). The age range of patients was from 1 to 66 years; 131 of the patients were younger than 21 years, and 90 of them were older than 21.
In most of the cases, if the family member was HLA-compatible, related allo-HSCT was performed. For the other patients an unrelated donor was searched for and activated in the international donor database. In the absence of fully-matched donors haploidentical HSCT (haplo-HSCT) was performed (usually from the patient’s mother). Overall, 135 pts underwent unrelated allo-HSCT, 77 pts related allo-HSCT, and 9 pts haplo-HSCT.
Allo-HSCT was performed in 91 pts with acute lymphoblastic leukemia (ALL), 57 pts with acute myeloid leukemia (AML), 2 pts with acute biphenotypic leukemia (BiAL), 25 pts with chronic myelo- and lymphoproliferative disorders (CMPD, CLPD), 1 pt with hypereosinophilic syndrome (HES), 11 pts with severe aplastic anemia (АА), 8 pts with congenital disorders, 5 pts with Hodgkin’s lymphoma (HL), 11 pts with non-Hodgkin’s lymphoma (NHL), 6 pts with myelodysplastic syndrome (MDS), 1 with primary myelofibrosis (MF), and 3 pts with solid tumors.
Allo-HSCT was performed in cases of remission (134 pts), and also in patients with relapse and progression (87 pts) of their disease (Table 1).
Table 1. Characteristics of the patients who underwent allo-HSCT
For 86 recipients (39%) myeloablative conditioning (MC) regimens were used, containing busulfan 16 mg/kg, and cyclophosphamide 120 mg/m2 [11]. Allo-HSCT in 135 pts (61%) was performed after a reduced-intensity conditioning (RIC) regimen of fludarabine 150 mg/m2, and busulfan 8 mg/kg or melphalan 140 mg/m2 [12].
In 67 pts the source of the hematopoietic stem cells (HSC) was bone marrow (BM), and in 142 pts peripheral blood stem cells (PBSC) were used. In 12 pts a combination of both sources were used due to insufficient СD34+/kg value after the first cell procurement. The total value of СD 34+/kg ranged from 3.0 to 8.0 х 10/6kg.
The EBMT criteria were used for the assessment of hematopoietic recovery after allo-HSCT: neutrophils at 0.5х109/l for at least 3 days without any granulocyte colony-stimulating factor (G-CSF) administration, trombocytes 20х109/l for at least 3 days without transfusions.
For aGVHD prophylaxis cyclosporine A at 3mg/kg from D-1 in combination with a short course of methotrexate 10 mg/m2 was given on D+1, +3 and +6, or, in other cases, mycophenolate mophetil (MMF) 30 mg/kg from D+1. Another regimen was the combination of tacrolimus 0.03 mg/kg from D-1 and MMF 30 mg/kg from D+1. Anti-thymocyte globulin (ATG) or alemtuzumab were added in unrelated allo-HSCT and haplo-HSCT, and quite rarely, related allo-HSCT cases.
Corticosteroids (1–3 mg/kg of prednisolone or methylprednisolone) with gradual tapering were used as the first line of treatment of aGVHD or cGVHD. For aGVHD with intestinal involvement, topical steroids (budesonide) were added to the therapy scheme at the rate of up to 9 mg/day. As a second line of immunosuppression TNF-б blockers (infliximab, etanercept), and IL-2 receptor blockers (daclizumab) were used; cGVHD was treated with anti-CD20 antibodies (rituximab). The grade of aGVHD and cGVHD were defined according to international criteria [16].
Patients’ examination before allo-HSCT and in the early post-transplant period
Pre-transplant examination of patients included serological screening for the following infections: cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus type 1 and 2 (HSV), and toxoplasmosis. Additionally, bacteriological and mycological studies (evaluation of blood, urine, stool and pharyngeal smear cultures) were performed on all patients.
In the early post-transplant period (up to D+100), the CMV status was monitored by PCR. Fungal infection monitoring was performed once a week by testing the galactomannan level via a latex-agglutination test (Enzyme-Linked Immunosorbent Assay, Platelia Aspergillus, Bio Rad) and, if the results were stable negative the test was performed bi-weekly. Early diagnostics of IM were performed using chest CT scans.
If any signs of infection were discovered, the microbiological, mycological (including galactomannan assay), and virological studies were repeated. To determine the localization of infection, chest X-ray or CT scan, abdominal US-scan, MRT or CT brain scans were performed.
In certain cases bronchoscopy with a study of bronchoalveolar lavage (BAL) cultures, or ophtalmoscopy with pupil dilatation were done.
Prophylaxis against infectious complications in allo-HSCT recipients
Allo-HSCT recipients were treated in wards with HEPA-filtered air. Selective decontamination was conducted from D-7 to D-1, then from D+1 up until recovery of granulocyte count of 0.5х109/l, and included the following antibacterial drugs: Ciprofloxacin 10 mg/kg/day, metronidazole 30 mg/kg/day; non-absorbing antibiotics per os (80 mg gentamycin 80 and 50000 units of amphotericin-B in form of water suspension).
All patients received trimethoprim/sulfametoxasol (5 mg/kg/day trimethoprim) as Pneumocystis carinii infection prophylaxis, which continued after engraftment until the completion of immunosuppressive therapy.
For herpes viral infection prophylaxis all patients received zovirax (5 mg/kg) from D-7 until D-1, then from D+1 until the end of immunosuppressive therapy.
Ganciclovir (5 mg/kg) was used for CMV infection prophylaxis in the patients with more than 103 copies by polymerase chain reaction (PCR).
The choice of antifungal drug for prophylaxis against IFD was based on anamnesis data on previous fungal infections, duration and severity of chemotherapy-induced neutropenia prior to allo-HSCT, and the type and stage of disease. Different generations of azoles were prescribed in 212 recipients test subject group: fluconazole (400 mg/day in adults, 6 mg/kg/day in children) in 155 pts, itraconazole (200 mg/day in adults, 8 mg/kg/day in children) in 19 pts, and voriconazole (6 mg/kg/day the 1st day, then 4 mg/kg/day in adults and 14 mg/kg/day in children) in 37 pts. For primary prophylaxis 4 pts received caspofungin (70 mg/kg/day the 1st day, then 50 mg/kg/day, no age adjustments were used). In one of the patients with resistant soft tissues IFD caused by a. flavus and a. fumigatus, caspofungin (70 mg/kg/day the 1st day, then 50 mg/kg/day) and posaconazole (800 mg/day) were given as secondary prophylaxis before haplo-HSCT.
Invasive fungal diseases was classified according to EORTC/MSG 2005 criteria based on host risk factors, clinical presentations, and infectious agent identification. The host risk factors considered were congenital immunodeficiency, immunosuppressive therapy by calcinerim inhibitors, long courses (more than 3 weeks) of steroids, prolonged (more than 10 days) neutropenia (ANC<0,5х109/l) and previous therapy with monoclonal antibodies (MABs), б-TNF inhibitors or antilymphocyte globulin. Fever was considered non-specific to fungal infections; it was regarded as a host factor. Based on these criteria, all IFD was divided into three forms: possible , probable , and proven. For verification of IFD (proven IFD) the fungal culture or a biopsy specimen with fungal mycelium visible by light microscopy had to be obtained from normally sterile tissue. Probable IFD was characterized by the presence of host factors, characteristic lesions on chest, brain or sinus CT scan, and/or characteristic changes discovered by abdominal US-scan or fundoscopy. For probable IFD the following criteria were used: fungal mycelium detectable by light microscopy in a normally non-sterile tissue specimen (sinus mucosa or BAL) and/or positive culture from sinus aspirate or BAL, positive Aspergillus antigen in blood, spinal fluid or BAL.
Possible IFD was characterized by the presence of host factors and characteristic clinical findings with no according laboratory confirmation [13].
Statistics
Fisher's exact test, the chi-quadrat test and the Mann-Whitney test were used for statistical data processing. Descriptive statistics methods were used for validation of continuous variables. Risks were calculated using likelihood ratios. Distinctions were considered reliable if error probability was below 0.05 (р≤0.05).
Results
Patients with possible, probable and proven IFD were included in the analysis. The occurrence of IFD between October 2000 and July 2008 amounted to 60/221 (27%) in the early post-allo-HSCT period and 8/221 (4%) in the late post-allo-HSCT period.
After allo- HSCT according to the EORTC/MSG definitions 2005 was diagnosed in 27 patients possible IFD, in 38 patients probable and in 3 patients proven (Fig.1).
Figure 1. IFD according to the EORTC/MSG definitions in patients after allo- HSCT
Probable aspergillosis involving the lungs was diagnosed in 32 pts; one patient had simultaneous lung and brain lesions, and lungs and sinus lesions occurred in 3pts. One post-haplo-HSCT patient had lung lesions caused by A. fumugatus and Cryptococcal CNS infection.
Possible aspergillosis with lung involvement was diagnosed in 24 pts; combined involvement of lungs and sinus in 3 pts.
Chronic disseminated candidiasis (CDC) was revealed in 2 pts, and C. krusei was detected in one patient. Candidemia was caused by C. parapsilosis in 3 pts.
In 25 pts IFD was diagnosed before allo-HSCT treatment. In all of these cases the necessary degree of infection control was obtained prior to allogeneic transplant procedure. IFD reactivation after allo-HSCT was noted in 10 of 25 (40%) pts.
The most common target organ of possible and probable IFD was the lung. Lung involvement was found in 51% of IFD patients younger than 21 (HR=10; 95% confidence range, 5.6–21.3 Р<0.05), and 49% of IFD patients older than 21 (HR=11; 95% confidence range, 5.6–21.3 Р<0.05). The other targeted organs were the sinuses: 6/68 (8%) of patients, and the brain: 2/68 (3%) of patients.
When looking at CT-scans results, specific lesions were revealed in 12 pts, in 32 cases signs of IFD were nonspecific, in 7 cases changes were not revealed; in 18 pts a CT-scan was not done. The ELISA-test was performed on 35pts only: galactomannan was positive in 27 pts and negative in 8 pts.
In the younger (≤21 years) patients, IFD was found in 12/43 (28%) pts after related allo-HSCT, in 28/80 (35%) pts after unrelated allo-HSCT, and in 3/8 (38%) pts after haplo-HSCT (Fig. 2).
Figure 2. Incidence of IFD after allo-HSCT in patients ≤21 years old
In older (>21 years) patients, IFD was found after related allo-HSCT in 7/34 (20%) pts and in 18/55 (33%) pts after unrelated allo-HSCT; the one patient who was treated with haplo-HSCT did not develop IFD (Fig. 3).
Figure 3. Incidence of IFD after allo-HSCT in patients >21 years old
In the case of younger patients (≤21 years) who were given RIC and allo-HSCT, IFD was diagnosed in 20/63 (32%) cases and in 4/23 (17%) pts in the older group (>21 years). IFD was diagnosed in 23/68 (34%) cases in the younger patients' group, and in 21/67 (31%) of older patients who were given MC. The median of IM diagnosis after allo-HSCT with RIC was at D+88 (day 13–740) and at D+ 86 (day 1–940) after allo-HSCT combined with MC.
The characteristics of patients with IFD are shown in tables 2 and 3.
Table 2. IFD characteristics in patients ≤21 years
Table 3. IM characteristics in patients >21 years
In allo-HSCT recipients >21 years old the incidence of IFD was 1.8-fold higher after allo-HSCT with RIC than in patients who had undergone an MC regimen (hazards ratio (HR)=1.2; 95% confidence range, 1.01–1.6, р<0.05). In the group of elder patients, the incidence of IM after related allo-HSCT was higher in patients given an RIC regimen in relapse (HR=0.5; 95% confidence range, 0.3–0.9, р <0.05).
Different grades of mucositis influence the frequency of IFD occurrence in both age groups (HR=2.1; 95% confidence range, 1.2–3.8, р<0.05 for patients ≤21 years; HR=2.1; 95% confidence range, 1.2–3.8, р<0.05 for patients >21 years).
When looking at the source of HSC, the following incidence rates of IFD were observed: for BM recipients ≤21 years it amounted to 12/43 (28%) pts; for the patients of the same age group that received PBSC it was 27/78 (35%). IFD was diagnosed in 4/10 (40%) pts that received HSC from a mixed (BM and PBSC) source. In the elder age group the incidence of IFD amounted to 4/24 (16%) of patients that received BM, 20/64 (31%) of PBSC recipients, and IFD developed in 1/2 (50%) patients who received cells from a mixed source. The comparison didn’t show up as statistically valid (p>0.05).
Multivariate analysis revealed the influence of the following risk factors on the probability of IFD development in younger (≤21 years) patients. These factors are allo-HSCT conducted in relapse, and the usage of RIC regimens before allo-HSCT with BM (HR=0.4; 95% confidence range, 0.21–0.76, р<0.05). The incidence of IFD was noticeably lower in the group of patients older than 21 who were transplanted in remission using a HLA-compatible related donor with MC where PBSC was the HSC source than in groups of patients with any other risk factors (HR=1.59; 95% confidence range, 1.01–2.51, р<0.05).
The introduction of ALG into the conditioning regimen for patients of the elder (>21 years) age group increased the possibility of IFD (HR=0.7; 95% confidence range, 0.59–0.88, р<0.05). In the younger (≤21 years) age group this difference was not statistically valid.
The rate of engraftment after allo-HSCT had no effect on the incidence and time of diagnosis of IFD in either age group. In patients ≤21 years the engraftment was noted on D+19±8 (from D+13 to D+46); in patients >21 years on D+16±4 (from D+9 to D+29) (р>0.05).
In patients ≤21 years with grade I–III aGVHD IFD developed in 17/66 (26%) cases; in 5/13 (46%) pts with grade IV aGVHD and 4/26 (15%) pts with an extensive form of cGVHD. In patients with an extensive form of cGVHD the incidence of IFD was significantly higher (HR= 2.1; 95% confidence range, 1.3–3.4, р<0.05). In patients >21 years IFD developed in 12/45 (27%) cases with grade I–III aGVHD, and in 2/11 (18%) pts with grade IV aGVHD. IFD also developed in 2/13 (15%) pts with extensive cGVHD following aGVHD.
In the elder (>21 years) group of patients the following incidence of IFD depending on antifungal prophylaxis was observed: under fluconazole in 29/94 (30%) pts, under itraconazole in 2/8 (25%) pts, under voriconazole in 13 of 25 (52%) pts; and no IFD developed in patients that received prophylaxis with caspofungine (2 pts) or posaconazole (1pt). For the younger group the IFD incidence under fluconazole was in 19 of 61 (31%) pts, under itraconazole in 2 of 11 (18%) pts, under voriconazole in 3 of 12 (25%) pts and no IFD cases emerged under prophylaxis with caspofungine (0/2). The difference of IFD incidence between these age groups had no statistical significance (p>0.05).
The 12-weeks overall survival (OS) after diagnosis of IFD in patients after allo-HSCT is 50%.
Figure 4. 12-weeks OS after diagnosis of IFD in patients after allo-HSCT
Log Rank <0.05
The influence of IFD on 5-year (OS) after allo-HSCT in both age groups was 40% (without IFD) and 18% (with IFD) (Fig.5).
Figure 5. 5-years OS in patients after allo-HSCT with and without IM
Conclusion
The incidence of IFD after allo-HSCT remains high. Depending on donor characteristics (HLA-matched related, unrelated or haploidentical donor) it is 28%, 35%, and 38% respectively.
Looking at age it is 32% for patients ≤21 years, and 27% for patients >21 years. The overall IFD incidence is slightly higher than in similar studies [15], but this may be explained by the characteristics of the groups analyzed. In our study 87/221 (39%) pts underwent allo-HSCT in relapse, and this proved to be a risk factor.
Despite the fact that age above 10 years was considered a risk factor for IFD development in both early and late periods after allo-HSCT [14], in this study the age was not an independent risk factor of IFD. In the RIC regimen group IFD was diagnosed in 34% of younger (≤21 years) patients and 31% of older (>21 years); and for the MC group it amounted to 32% for younger (p>0.05) and 17% for elder age groups (p<0.05). Neither the rate of IFD in both age groups, the source of HSC and/or rate of post-transplant engraftment were found to independently exert influence on the incidence of IFD following allo-SCT.
IFD incidence was 1.8-fold higher in elder relapsed patients after related allo-HSCT with RIC (p<0.05). Contrariwise, in this group the incidence of IFD was low in patients that underwent HSCT in remission and received PBSC (p<0.05). The possible reason for this could be the population structure of G-CSF-stimulated donor PBSC, which alleviates immune reconstitution [9]. The influence of transplant type was also noticed in the younger (≤21 years) group: the probability of IFD development was much higher in relapsed patients after BM allo-HSCT with RIC (p<0.05). It was noticed that the disease stage, grade I–IV mucositis (p<0.05), and extensive cGVHD (p<0.05) were the most prominent risk factors for IFD development. When these factors are present no difference was seen in groups with different conditioning regimens and HSC sources.
In patients >21 years IFD incidence increased by inclusion of ATG in the conditioning regimen (p<0.05). Agents such as ATG, steroid-depressed function of immunocompetent cells (macrophages, granulocytes, monocytes and T-cells) and decreased production and secretion of pro-inflammatory cytokines (TNF, IFN-г, IL-2) secretion [9].
Our study revealed that IFD impairs the OS in patients after allo-HSCT in both age groups, but especially in patients older than 21 years.
In conclusion, the main risk factors that influence the incidence of IFD after allo-HSCT in all age groups are the stage of the disease, mucositis development, and extensive form of cGVHD.
References
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2. Mendeleeva LP, Mitish NE, Klyasova GA, et al. Infectious complications in the patients with acute leukemia after autologous HSCT. Internal medicine archive 2005;7:33-39. Russian.
3. International Bone Marrow Transplant Registry/Autologous Blood and Marrow Transplant Registry. IBMTR/ ABMTR Newsletter.
4. Pagano L et al. Fungal Infections in Recipients of HematopoieticStem Cell Transplants: Results of the SEIFEM B-2004 Study—Sorveglianza Epidemiologica Infezioni Fungine Nelle Emopatie Maligne. CID. 2007;45(1):1162-1170.
5. Upton et al. Invasive Aspergillosis following Hematopoietic Cell Transplantation: Outcomes and Prognostic Factors Associated with Mortality. CID. 2007;44(2):531.
6. Bow EJ. Of Yeasts and Hyphae: A Hematologist’s Approach to Antifungal Therapy. Hematology. 2006;(1):361-367.
7. John R. Wingard Antifungal Chemoprophylaxis after Blood and Marrow Transplantation. CID. 2002;34(15 May):1386-1390.
8. Marr K et al. Invasive aspergillosis in allogeneic stem cell transplant recipients; changes in epidemiology and risk factors. Blood. 100:4358-4366.
9. Safdar A. Strategies to enhance immune function in hematopoietic transplantation recipients who have fungal infection. Bone marrow transplantation. 2006;38:327-337.
10. Wiederhold NP et al. Invasive aspergollosis in patients with hematologic malignancies. Pharmacotherapy. 2003;23:1592-1610.
11. Tuschka et al. Bone Marrow Transplant. 1993;12(1):34-36.
12. Slavin S et al. Nonmyeloablative stem cell transplantation and cell therapy as an alternative to conventional bone marrow transplantation with lethal cytoreduction for the treatment of malignant and nonmalignant hematological diseases. Blood. 1998;91:756-763.
13. De Pauw B et al. Revised Definitions of Invasive Fungal Disease from the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections, Cooperative Group and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) Consensus Group. CID. 2008;46(15):1813-1821.
14. Dvorak C et al. Risks and outcomes of invasive fungal infections in pediatric patients undergoing allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation. 2005;36:621–629.
15. Richardson MD. Changing patterns and trends in systemic fungal infections. Journal of Antimicrobial Chemotherapy. 2005;56(S):5-11.
16. Deeg HJ. How I treat refractory acute GVHD. Blood. 2007;109(10):4119-4126.
17. Garcia-Vidal C et al. Epidemiology of invasive mold infections in allogeneic stem cell transplant recipients: biological risk factors for infection according to time after transplantation. CID. 2008;47(8):1041-1050.
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Из них до 21года – 131 пациентам, старше 21 года – 90 пациентам, медиана возраста составила 21 год (1-66 лет). У 87 пациентов (39,4%) алло-ТГСК произведена в рецидиве заболевания.<h3>Результаты</h3> <p>Частота ИМ при алло-ТГСК составила 28%, 35% и 38% соответвенно при использовании родственного, неродственного и гаплоидентичного доноров, а также 32% у пациентов до 21 года и 27% в группе пациентов старше 21 года. ИМ диагностирован соответственно у 32% и 17% пациентов с МРК (миелоаблативный кондиционирующий режим кондиционирования), у 34% и 31% с не МРК до 21 года и старше (p>0,05). В обеих группах источник ГСК, скорость восстановления кроветворения донора не имели самостоятельного воздействия при оценке вероятности возникновения ИМ у пациентов после алло-ТГСК. <br /><br />Значение возраста и источника ГСК усиливалось при многофакторном анализе параметров, влиющих на развитие ИМ после алло-ТГСК. Проведение алло-ТГСК от родственного донора с неМРК в рецидиве заболевания увеличивало риск развития ИМ в 1,8 раза у пациентов старше 21 (p<0,05). Напротив, при алло-ТГСК в ремиссии ИМ развивался реже, особенно при использовании ПСКК (p<0,05). </p> <p class="bodytext">Влияние трансплантата отмечено и в возрасте до 21 года, где вероятность развития ИМ была выше при проведении алло-ТГСК в рецидиве заболевания с МРК и КМ в качестве источника трансплнтата (p>0,05). </p> <p class="bodytext">Установлено, что стадия заболевания, мукозит I-IV степени (p<0,05) и распространенная форма хронической РТПХ (p<0,05) являются наиболее значимыми отрицательными факторами. Их наличие создаёт условия для развития ИМ вне зависимости от режима кондиционирования и источника трансплантата. <br /> <br />В возрасте старше 21 года назначение АЛГ в режиме кондиционирования увеличивало вероятность развития ИМ (p<0,05). Общая 5-летняя выживаемость пациентов всех возрастных групп вне зависимости от стадии заболевания составила 40% и 18% при отсутствии и наличии ИМ, соответственно. </p> <h3>Заключение</h3> <p>Таким образом, наличие ИМ влияет на 5-летнюю ОВ пациентов. 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И. Зубаровская, Е. В. Семенова, Н. В. Станчева, В. Н. Вавилов, И. В. Казанцев, Ю. Г. Васильева, Н. Н. Климко,<br> Б. В. Афанасьев</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(235) "Н. И. Зубаровская, Е. В. Семенова, Н. В. Станчева, В. Н. Вавилов, И. В. Казанцев, Ю. Г. Васильева, Н. Н. Климко,
Б. В. Афанасьев
Цель исследования
Определить частоту ИМ у пациентов после алло-ТГСК, выявить факторы риска, способствующие развитию ИМ.
Материалы и методы
С 2000г. по июнь 2008г. выполнена 221 алло-ТГСК от неродственного, родственного, частично совместимого (гаплоидентичного) донора. Из них до 21года – 131 пациентам, старше 21 года – 90 пациентам, медиана возраста составила 21 год (1-66 лет). У 87 пациентов (39,4%) алло-ТГСК произведена в рецидиве заболевания.
Результаты
Частота ИМ при алло-ТГСК составила 28%, 35% и 38% соответвенно при использовании родственного, неродственного и гаплоидентичного доноров, а также 32% у пациентов до 21 года и 27% в группе пациентов старше 21 года. ИМ диагностирован соответственно у 32% и 17% пациентов с МРК (миелоаблативный кондиционирующий режим кондиционирования), у 34% и 31% с не МРК до 21 года и старше (p>0,05). В обеих группах источник ГСК, скорость восстановления кроветворения донора не имели самостоятельного воздействия при оценке вероятности возникновения ИМ у пациентов после алло-ТГСК.
Значение возраста и источника ГСК усиливалось при многофакторном анализе параметров, влиющих на развитие ИМ после алло-ТГСК. Проведение алло-ТГСК от родственного донора с неМРК в рецидиве заболевания увеличивало риск развития ИМ в 1,8 раза у пациентов старше 21 (p<0,05). Напротив, при алло-ТГСК в ремиссии ИМ развивался реже, особенно при использовании ПСКК (p<0,05).
Влияние трансплантата отмечено и в возрасте до 21 года, где вероятность развития ИМ была выше при проведении алло-ТГСК в рецидиве заболевания с МРК и КМ в качестве источника трансплнтата (p>0,05).
Установлено, что стадия заболевания, мукозит I-IV степени (p<0,05) и распространенная форма хронической РТПХ (p<0,05) являются наиболее значимыми отрицательными факторами. Их наличие создаёт условия для развития ИМ вне зависимости от режима кондиционирования и источника трансплантата.
В возрасте старше 21 года назначение АЛГ в режиме кондиционирования увеличивало вероятность развития ИМ (p<0,05). Общая 5-летняя выживаемость пациентов всех возрастных групп вне зависимости от стадии заболевания составила 40% и 18% при отсутствии и наличии ИМ, соответственно.
Заключение
Таким образом, наличие ИМ влияет на 5-летнюю ОВ пациентов. Основными факторами риска, влияющими на частоту ИМ после алло-ТГСК в возрастных группах до и старше 21 года являются стадия заболевания, развитие мукозита и распространенной формы хрРТПХ.
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R. M. Gorbacheva Memorial Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University,
St. Petersburg, Russia
Correspondence: Natalia Zubarovskaya, Memorial R.M. Gorbacheva Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, 6/8, Tolstoy str., St. Petersburg, 199044, Russia, Tel.: +7 (812) 499-68-19, Fax: +7 (812) 234-06-16,
E-mail: zoubarov@mail.ru
Background
The aim of the study was to determine the risk factors and incidence of invasive fungal diseases (IFD) in patients after allo-HSCT.
Materials and patients
In our department 221 allo-HSCTs from related, unrelated and haploidentical donors were performed between October 2000 and June 2008. In the study were enrolled 131 patients younger than 21 and 90 patients older than 21 years old after allo-HSCT. In 87 (37%) patients allo-HSCT was conducted in non-remission.
Results
The incidence of IFD after allo-HSCT remains high. Depending on donor characteristics (HLA-matched related, unrelated or haploidentical donor) it is 28%, 35%, and 38% respectively. Looking at age it is 32% for patients ≤21 years, and 27% for patients >21 years. In the RIC regimen group IFD was diagnosed in 34% of younger (≤21 years) patients and 31% of older (>21 years); and for the MC group it amounted to 32% for younger (p>0.05) and 17% for elder age groups (p<0.05). Neither the rate of IFD in both age groups, the source of HSC and/or rate of post-transplant engraftment were found to independently exert influence on the incidence of IFD following allo-SCT.
In multifactor analysis was noticed correlation between HSC sources and age.
IFD incidence was 1.8-fold higher in elder relapsed patients after related allo-HSCT with RIC (p<0.05). Contrariwise, in this group the incidence of IFD was low in patients that underwent HSCT in remission and received PBSC (p<0.05). The influence of transplant type was also noticed in the younger (≤21 years) group: the probability of IFD development was much higher in relapsed patients after BM allo-HSCT with RIC (p<0.05). It was noticed that the disease stage, grade I–IV mucositis (p<0.05), and extensive cGVHD (p<0.05) were the most prominent risk factors for IFD development. When these factors are present no difference was seen in groups with different conditioning regimens and HSC sources.
In patients >21 years IFD incidence increased by inclusion of ATG in the conditioning regimen (p<0.05).
Conclusions
The main risk factors that influence the incidence of IFD after allo-HSCT in all age groups are the stage of the disease, mucositis development, and extensive form of cGVHD. After diagnosis of IFD 12-weeks OS is 50%. IFD impairs 5-years OS after allo-HSCT.
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N. I. Zubarovskaya, E. V. Semenova, N. V. Stancheva, V. N. Vavilov, I. V. Kazantsev, Yu. G. Vasilieva, N. N. Klimko, B. V. Afanasyev
" } ["SUMMARY_EN"]=> array(37) { ["ID"]=> string(2) "39" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:02:59" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(21) "Description / Summary" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_EN" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "39" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "12918" ["VALUE"]=> array(2) { ["TEXT"]=> string(2628) "<h3>Background</h3> <p> The aim of the study was to determine the risk factors and incidence of invasive fungal diseases (IFD) in patients after allo-HSCT.</p> <h3>Materials and patients</h3> <p>In our department 221 allo-HSCTs from related, unrelated and haploidentical donors were performed between October 2000 and June 2008. In the study were enrolled 131 patients younger than 21 and 90 patients older than 21 years old after allo-HSCT. In 87 (37%) patients allo-HSCT was conducted in non-remission.</p> <h3>Results</h3> <p>The incidence of IFD after allo-HSCT remains high. Depending on donor characteristics (HLA-matched related, unrelated or haploidentical donor) it is 28%, 35%, and 38% respectively. Looking at age it is 32% for patients ≤21 years, and 27% for patients >21 years. In the RIC regimen group IFD was diagnosed in 34% of younger (≤21 years) patients and 31% of older (>21 years); and for the MC group it amounted to 32% for younger (p>0.05) and 17% for elder age groups (p<0.05). Neither the rate of IFD in both age groups, the source of HSC and/or rate of post-transplant engraftment were found to independently exert influence on the incidence of IFD following allo-SCT. <br /><br />In multifactor analysis was noticed correlation between HSC sources and age.<br /><br />IFD incidence was 1.8-fold higher in elder relapsed patients after related allo-HSCT with RIC (p<0.05). Contrariwise, in this group the incidence of IFD was low in patients that underwent HSCT in remission and received PBSC (p<0.05). The influence of transplant type was also noticed in the younger (≤21 years) group: the probability of IFD development was much higher in relapsed patients after BM allo-HSCT with RIC (p<0.05). It was noticed that the disease stage, grade I–IV mucositis (p<0.05), and extensive cGVHD (p<0.05) were the most prominent risk factors for IFD development. When these factors are present no difference was seen in groups with different conditioning regimens and HSC sources. <br /><br />In patients >21 years IFD incidence increased by inclusion of ATG in the conditioning regimen (p<0.05). </p> <h3>Conclusions</h3> <p>The main risk factors that influence the incidence of IFD after allo-HSCT in all age groups are the stage of the disease, mucositis development, and extensive form of cGVHD. After diagnosis of IFD 12-weeks OS is 50%. IFD impairs 5-years OS after allo-HSCT.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2452) "
Background
The aim of the study was to determine the risk factors and incidence of invasive fungal diseases (IFD) in patients after allo-HSCT.
Materials and patients
In our department 221 allo-HSCTs from related, unrelated and haploidentical donors were performed between October 2000 and June 2008. In the study were enrolled 131 patients younger than 21 and 90 patients older than 21 years old after allo-HSCT. In 87 (37%) patients allo-HSCT was conducted in non-remission.
Results
The incidence of IFD after allo-HSCT remains high. Depending on donor characteristics (HLA-matched related, unrelated or haploidentical donor) it is 28%, 35%, and 38% respectively. Looking at age it is 32% for patients ≤21 years, and 27% for patients >21 years. In the RIC regimen group IFD was diagnosed in 34% of younger (≤21 years) patients and 31% of older (>21 years); and for the MC group it amounted to 32% for younger (p>0.05) and 17% for elder age groups (p<0.05). Neither the rate of IFD in both age groups, the source of HSC and/or rate of post-transplant engraftment were found to independently exert influence on the incidence of IFD following allo-SCT.
In multifactor analysis was noticed correlation between HSC sources and age.
IFD incidence was 1.8-fold higher in elder relapsed patients after related allo-HSCT with RIC (p<0.05). Contrariwise, in this group the incidence of IFD was low in patients that underwent HSCT in remission and received PBSC (p<0.05). The influence of transplant type was also noticed in the younger (≤21 years) group: the probability of IFD development was much higher in relapsed patients after BM allo-HSCT with RIC (p<0.05). It was noticed that the disease stage, grade I–IV mucositis (p<0.05), and extensive cGVHD (p<0.05) were the most prominent risk factors for IFD development. When these factors are present no difference was seen in groups with different conditioning regimens and HSC sources.
In patients >21 years IFD incidence increased by inclusion of ATG in the conditioning regimen (p<0.05).
Conclusions
The main risk factors that influence the incidence of IFD after allo-HSCT in all age groups are the stage of the disease, mucositis development, and extensive form of cGVHD. After diagnosis of IFD 12-weeks OS is 50%. IFD impairs 5-years OS after allo-HSCT.
" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(21) "Description / Summary" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(2452) "Background
The aim of the study was to determine the risk factors and incidence of invasive fungal diseases (IFD) in patients after allo-HSCT.
Materials and patients
In our department 221 allo-HSCTs from related, unrelated and haploidentical donors were performed between October 2000 and June 2008. In the study were enrolled 131 patients younger than 21 and 90 patients older than 21 years old after allo-HSCT. In 87 (37%) patients allo-HSCT was conducted in non-remission.
Results
The incidence of IFD after allo-HSCT remains high. Depending on donor characteristics (HLA-matched related, unrelated or haploidentical donor) it is 28%, 35%, and 38% respectively. Looking at age it is 32% for patients ≤21 years, and 27% for patients >21 years. In the RIC regimen group IFD was diagnosed in 34% of younger (≤21 years) patients and 31% of older (>21 years); and for the MC group it amounted to 32% for younger (p>0.05) and 17% for elder age groups (p<0.05). Neither the rate of IFD in both age groups, the source of HSC and/or rate of post-transplant engraftment were found to independently exert influence on the incidence of IFD following allo-SCT.
In multifactor analysis was noticed correlation between HSC sources and age.
IFD incidence was 1.8-fold higher in elder relapsed patients after related allo-HSCT with RIC (p<0.05). Contrariwise, in this group the incidence of IFD was low in patients that underwent HSCT in remission and received PBSC (p<0.05). The influence of transplant type was also noticed in the younger (≤21 years) group: the probability of IFD development was much higher in relapsed patients after BM allo-HSCT with RIC (p<0.05). It was noticed that the disease stage, grade I–IV mucositis (p<0.05), and extensive cGVHD (p<0.05) were the most prominent risk factors for IFD development. When these factors are present no difference was seen in groups with different conditioning regimens and HSC sources.
In patients >21 years IFD incidence increased by inclusion of ATG in the conditioning regimen (p<0.05).
Conclusions
The main risk factors that influence the incidence of IFD after allo-HSCT in all age groups are the stage of the disease, mucositis development, and extensive form of cGVHD. After diagnosis of IFD 12-weeks OS is 50%. IFD impairs 5-years OS after allo-HSCT.
" } ["DOI"]=> array(37) { ["ID"]=> string(2) "28" ["TIMESTAMP_X"]=> string(19) "2016-04-06 14:11:12" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(3) "DOI" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(3) "DOI" ["DEFAULT_VALUE"]=> string(0) "" ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "80" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "28" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> NULL ["USER_TYPE_SETTINGS"]=> NULL ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "12877" ["VALUE"]=> string(29) "10.3205/ctt-2009-en-000036.01" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(29) "10.3205/ctt-2009-en-000036.01" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(3) "DOI" ["~DEFAULT_VALUE"]=> string(0) "" ["DISPLAY_VALUE"]=> string(29) "10.3205/ctt-2009-en-000036.01" } ["NAME_EN"]=> array(37) { ["ID"]=> string(2) "40" ["TIMESTAMP_X"]=> string(19) "2015-09-03 10:49:47" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(4) "Name" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(7) "NAME_EN" ["DEFAULT_VALUE"]=> string(0) "" ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "80" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "40" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "Y" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> NULL ["USER_TYPE_SETTINGS"]=> NULL ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "12878" ["VALUE"]=> string(93) "Invasive fungal diseases in patients after allogeneic hematopoietic stem cell transplantation" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(93) "Invasive fungal diseases in patients after allogeneic hematopoietic stem cell transplantation" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(4) "Name" ["~DEFAULT_VALUE"]=> string(0) "" ["DISPLAY_VALUE"]=> string(93) "Invasive fungal diseases in patients after allogeneic hematopoietic stem cell transplantation" } ["ORGANIZATION_EN"]=> array(37) { ["ID"]=> string(2) "38" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:02:59" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(12) "Organization" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_EN" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "38" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "12917" ["VALUE"]=> array(2) { ["TEXT"]=> string(767) "<p>R. M. Gorbacheva Memorial Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, <br>St. Petersburg, Russia</p> <br> <p class="bodytext"><b>Correspondence:</b> Natalia Zubarovskaya, Memorial R.M. Gorbacheva Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, 6/8, Tolstoy str., St. Petersburg, 199044, Russia, Tel.: +7 (812) 499-68-19, Fax: +7 (812) 234-06-16,<br> E-mail: <a href="javascript:linkTo_UnCryptMailto('qempxs.dsyfevszDqemp2vy');">zoubarov@<span style="display:none;">spam is bad</span>mail.ru</a> <sup><br /></sup> </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(641) "R. M. Gorbacheva Memorial Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University,
St. Petersburg, Russia
Correspondence: Natalia Zubarovskaya, Memorial R.M. Gorbacheva Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, 6/8, Tolstoy str., St. Petersburg, 199044, Russia, Tel.: +7 (812) 499-68-19, Fax: +7 (812) 234-06-16,
E-mail: zoubarov@mail.ru
R. M. Gorbacheva Memorial Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University,
St. Petersburg, Russia
Correspondence: Natalia Zubarovskaya, Memorial R.M. Gorbacheva Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, 6/8, Tolstoy str., St. Petersburg, 199044, Russia, Tel.: +7 (812) 499-68-19, Fax: +7 (812) 234-06-16,
E-mail: zoubarov@mail.ru
Н. И. Зубаровская, Е. В. Семенова, Н. В. Станчева, В. Н. Вавилов, И. В. Казанцев, Ю. Г. Васильева, Н. Н. Климко,
Б. В. Афанасьев
Н. И. Зубаровская, Е. В. Семенова, Н. В. Станчева, В. Н. Вавилов, И. В. Казанцев, Ю. Г. Васильева, Н. Н. Климко,
Б. В. Афанасьев
Цель исследования
Определить частоту ИМ у пациентов после алло-ТГСК, выявить факторы риска, способствующие развитию ИМ.
Материалы и методы
С 2000г. по июнь 2008г. выполнена 221 алло-ТГСК от неродственного, родственного, частично совместимого (гаплоидентичного) донора. Из них до 21года – 131 пациентам, старше 21 года – 90 пациентам, медиана возраста составила 21 год (1-66 лет). У 87 пациентов (39,4%) алло-ТГСК произведена в рецидиве заболевания.
Результаты
Частота ИМ при алло-ТГСК составила 28%, 35% и 38% соответвенно при использовании родственного, неродственного и гаплоидентичного доноров, а также 32% у пациентов до 21 года и 27% в группе пациентов старше 21 года. ИМ диагностирован соответственно у 32% и 17% пациентов с МРК (миелоаблативный кондиционирующий режим кондиционирования), у 34% и 31% с не МРК до 21 года и старше (p>0,05). В обеих группах источник ГСК, скорость восстановления кроветворения донора не имели самостоятельного воздействия при оценке вероятности возникновения ИМ у пациентов после алло-ТГСК.
Значение возраста и источника ГСК усиливалось при многофакторном анализе параметров, влиющих на развитие ИМ после алло-ТГСК. Проведение алло-ТГСК от родственного донора с неМРК в рецидиве заболевания увеличивало риск развития ИМ в 1,8 раза у пациентов старше 21 (p<0,05). Напротив, при алло-ТГСК в ремиссии ИМ развивался реже, особенно при использовании ПСКК (p<0,05).
Влияние трансплантата отмечено и в возрасте до 21 года, где вероятность развития ИМ была выше при проведении алло-ТГСК в рецидиве заболевания с МРК и КМ в качестве источника трансплнтата (p>0,05).
Установлено, что стадия заболевания, мукозит I-IV степени (p<0,05) и распространенная форма хронической РТПХ (p<0,05) являются наиболее значимыми отрицательными факторами. Их наличие создаёт условия для развития ИМ вне зависимости от режима кондиционирования и источника трансплантата.
В возрасте старше 21 года назначение АЛГ в режиме кондиционирования увеличивало вероятность развития ИМ (p<0,05). Общая 5-летняя выживаемость пациентов всех возрастных групп вне зависимости от стадии заболевания составила 40% и 18% при отсутствии и наличии ИМ, соответственно.
Заключение
Таким образом, наличие ИМ влияет на 5-летнюю ОВ пациентов. Основными факторами риска, влияющими на частоту ИМ после алло-ТГСК в возрастных группах до и старше 21 года являются стадия заболевания, развитие мукозита и распространенной формы хрРТПХ.
" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(29) "Описание/Резюме" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(4528) "Цель исследования
Определить частоту ИМ у пациентов после алло-ТГСК, выявить факторы риска, способствующие развитию ИМ.
Материалы и методы
С 2000г. по июнь 2008г. выполнена 221 алло-ТГСК от неродственного, родственного, частично совместимого (гаплоидентичного) донора. Из них до 21года – 131 пациентам, старше 21 года – 90 пациентам, медиана возраста составила 21 год (1-66 лет). У 87 пациентов (39,4%) алло-ТГСК произведена в рецидиве заболевания.
Результаты
Частота ИМ при алло-ТГСК составила 28%, 35% и 38% соответвенно при использовании родственного, неродственного и гаплоидентичного доноров, а также 32% у пациентов до 21 года и 27% в группе пациентов старше 21 года. ИМ диагностирован соответственно у 32% и 17% пациентов с МРК (миелоаблативный кондиционирующий режим кондиционирования), у 34% и 31% с не МРК до 21 года и старше (p>0,05). В обеих группах источник ГСК, скорость восстановления кроветворения донора не имели самостоятельного воздействия при оценке вероятности возникновения ИМ у пациентов после алло-ТГСК.
Значение возраста и источника ГСК усиливалось при многофакторном анализе параметров, влиющих на развитие ИМ после алло-ТГСК. Проведение алло-ТГСК от родственного донора с неМРК в рецидиве заболевания увеличивало риск развития ИМ в 1,8 раза у пациентов старше 21 (p<0,05). Напротив, при алло-ТГСК в ремиссии ИМ развивался реже, особенно при использовании ПСКК (p<0,05).
Влияние трансплантата отмечено и в возрасте до 21 года, где вероятность развития ИМ была выше при проведении алло-ТГСК в рецидиве заболевания с МРК и КМ в качестве источника трансплнтата (p>0,05).
Установлено, что стадия заболевания, мукозит I-IV степени (p<0,05) и распространенная форма хронической РТПХ (p<0,05) являются наиболее значимыми отрицательными факторами. Их наличие создаёт условия для развития ИМ вне зависимости от режима кондиционирования и источника трансплантата.
В возрасте старше 21 года назначение АЛГ в режиме кондиционирования увеличивало вероятность развития ИМ (p<0,05). Общая 5-летняя выживаемость пациентов всех возрастных групп вне зависимости от стадии заболевания составила 40% и 18% при отсутствии и наличии ИМ, соответственно.
Заключение
Таким образом, наличие ИМ влияет на 5-летнюю ОВ пациентов. Основными факторами риска, влияющими на частоту ИМ после алло-ТГСК в возрастных группах до и старше 21 года являются стадия заболевания, развитие мукозита и распространенной формы хрРТПХ.
" } } } [2]=> array(49) { ["IBLOCK_SECTION_ID"]=> string(2) "39" ["~IBLOCK_SECTION_ID"]=> string(2) "39" ["ID"]=> string(3) "933" ["~ID"]=> string(3) "933" ["IBLOCK_ID"]=> string(1) "2" ["~IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(172) "Перегрузка железом: причины, методы оценки, значимость при трансплантации и подходы к терапии" ["~NAME"]=> string(172) "Перегрузка железом: причины, методы оценки, значимость при трансплантации и подходы к терапии" ["ACTIVE_FROM"]=> NULL ["~ACTIVE_FROM"]=> NULL ["TIMESTAMP_X"]=> string(22) "06/20/2017 01:52:47 pm" ["~TIMESTAMP_X"]=> string(22) "06/20/2017 01:52:47 pm" ["DETAIL_PAGE_URL"]=> string(128) "/en/archive/tom-1-nomer-3/stati/peregruzka-zhelezom-prichiny-metody-otsenki-znachimost-pri-transplantatsii-i-podkhody-k-terapii/" ["~DETAIL_PAGE_URL"]=> string(128) "/en/archive/tom-1-nomer-3/stati/peregruzka-zhelezom-prichiny-metody-otsenki-znachimost-pri-transplantatsii-i-podkhody-k-terapii/" ["LIST_PAGE_URL"]=> string(12) "/en/archive/" ["~LIST_PAGE_URL"]=> string(12) "/en/archive/" ["DETAIL_TEXT"]=> string(61058) "Introduction
Iron is an essential microelement in human body [17]. It is quite important co-factor of enzymes active in mitochondrial respiratory chain, citrate cycle, DNA synthesis, and plays a central role in oxygen binding to hemoglobin and myoglobin; iron-containing proteins are indispensable for collagen, tyrosine and catecholamine metabolism. But free, non-chelated iron, due to its catalytic action in a redox-reaction may form dangerous hydroxyl radicals that may cause cell death resulting from peroxidative damage of cell membranes. In the course of evolutionary development, this was resolved by formation of specialized molecules adapted to its intestinal absorption from food, its transport and deposition in soluble, non-toxic form.
Three crucial mechanisms are important for iron homeostasis, as follows:
• Iron absorption from food products in small intestine which, generally, compensates for physiological losses;
• IRE/IRP (Iron Responsive Element/Iron Regulatory Protein) system means intracellular iron uptake or its deposition in complex with ferritin. These processes provide cellular demands of iron and, at the same time, preventing toxic effect of iron overload;
• Erythrophagocytosis and recirculation of erythrocyte-derived iron, thus ensuring main requirements for iron during erythropoiesis.
These three mechanisms provide stabilization of iron stores in the organism, as well as its intracellular metabolism and bioavailability [17, 34].
The key point of intestinal iron absorption is hepcidin-mediated regulation system. Hepcidin, a peptide hormone made in the liver, is the principal regulator of systemic iron homeostasis. Hepcidin controls plasma iron concentration and tissue distribution of iron by inhibiting intestinal iron absorption, iron recycling by macrophages, and iron mobilization from hepatic stores. Hepcidin acts by inhibiting cellular iron efflux through binding to and inducing the degradation of ferroportin, the sole known cellular iron exporter. Synthesis of hepcidin is homeostatically increased by iron loading and decreased by anemia and hypoxia. Hepcidin is also elevated during infections and inflammation, causing a decrease in serum iron levels and contributing to the development of anemia of inflammation, probably as a host defense mechanism to limit the availability of iron to invading microorganisms [58].
Disorders associated with altered iron metabolism may be arbitrarily classified in two large groups: iron-deficient and iron overload states.
Iron deficiencies may be caused by alimentary factors (low amount of iron in food), increased iron losses (e.g., due to bleedings) and disturbed iron absorption (Crohn’s or celiac disease, surgical removal of part of intestine, the use of some medications etc).
The most common reasons for conditions, associated with iron overload, are as follows [60, 74]:
1. Genetic alterations of iron metabolism
• Hereditary haemochromatosis types 1-4
|
HFE-associated HH (type 1) |
|
C282Y homozygosity |
|
C282Y/H63D compound heterozygosity |
|
Non-HFE-associated HH |
|
Type 2A HJV variants |
|
Type 2B hepcidin variants |
|
Type 3 TfR variants |
|
Type 4 ferroportin variants |
• Acoeruloplasminaemia
• Atransferrinaemia
2. Genetic disturbances of erythropoiesis, and/or life cycle of red blood cells (hereditary dyserythropoietic, haemolytic anaemias, including thalassemias, sickle cell anaemia (SCA), Blakmond-Diamond anaemia)
3. Acquired conditions requiring long-term, repeated haemotransfusions (myelodysplastic syndrome (MDS), acute leukaemias, myelofibrosis, multiple myeloma etc)
4. Chronic liver diseases (hepatitis, alcohol abuse, nonalcoholic steatohepatitis etc)
Transfusion-associated iron overload
Iron overload due to RBC transfusions is a relatively common complication related to long-term treatment of various haematological diseases. Each unit of blood contains 200 mg of haeme iron, more than 100-fold than a daily amount of iron normally absorbed from the diet. Transfused red blood cells, upon their senescence, are degraded and their iron is re-utilized by resident macrophages. These fractions of bioavailable iron, after binding to transferring, are released into the circulation, and dissipate to body tissues. Iron overload is an inevitable consequence of regular transfusion therapy [37]. After receiving 20 lifetime units of packed red blood cells, patients can become iron overloaded. No matter how many years pass between transfusions, the dangers are the same, because the body has no way actively excrete excess iron. Iron overload is proportional to transfusion burden [67, 57].
When iron overload is evident, transferrin becomes saturated, thus leading to increased non-transferrin bound iron (NTBI) in blood plasma. Whereas tissue uptake of transferrin-bound iron is regulated by expression of membrane-bound transferrin receptor (responsible for transport of transferrin into cells [4]), excess of NTBI is often absorbed by susceptible tissues. This leads to pools of unbound iron within cells, which mediate toxicity by the formation of reactive oxygen species (ROS) [30]; Figure 1.
Figure 1.
ROS react with cellular components such as the plasma membrane, lysosomes, and organelle membranes, leading to cellular leakage, dysfunction, and, ultimately, cell death [33].
The organ damage that occurs with transfusional iron overload is similar to that seen in hereditary haemochromatosis, although iron accumulation occurs more rapidly, and deposition of iron in resident tissue macrophages is proportionally greater [43, 74, 77]. Hereditary haemochromatosis is characterized by iron accumulation primarily in the liver, heart, and pancreas. However, whereas chronic anaemias are related to errors in erythropoiesis, the main cause of haemochromatosis is a reduction or absence in expression of hepcidin (in particular, due to the haemochromatosis gene (HFE) mutations) [43, 74, 77].
Under steady-state conditions, hepcidin prevents excessive intestinal absorption of iron and its release from macrophages. Therefore it minimizes the amount of iron that enters into plasma. However, in conditions of chronic iron overload, blood transfusion leads to an increase in erythrocytes, which are broken down by macrophages. This initially results in an increase in iron levels in resident tissue macrophages. Hepcidin expression also downregulates iron release from this system, leading to a “build-up” in the reticuloendothelial system and its possible saturation (a stage that is reduced or absent in patients with haemochromatosis). Subsequently, iron is deposited in various tissues, thus leading to tissue damage [43, 46, 63].
It is well established that, prior to advent of iron-chelating therapy, cardiomyopathy and liver fibrosis associated with iron overload were among the leading causes of death among children with thalassemia [15, 61]. The role of iron overload in MDS patients is also well established. There are different data concerning overall survival and progression free survival in MDS patients according to transfusion dependency and serum ferritin level [49, 50, 51, 75, 78]. Studies have indicated that iron overload following RBC transfusions was an independent, adverse prognostic factor for overall survival (OS) and leukemia-free survival (LFS): OS and LFS were significantly shorter in transfusion-dependent patients with MDS than in those who were not transfusion dependent.
Accurate assessment of body iron burden is necessary to diagnose iron overload and also to effectively manage therapy.
Assessment of body iron stores
There are numerous methods available for the detection and assessment of iron levels, both as total body and specific tissue levels. Because transfusions may lead to rapid iron accumulation, monitoring a patient's number of transfused blood units, serum ferritin levels, and/or liver iron concentrations can play an essential role in the management of iron overload. Each method is associated with advantages and disadvantages [19, 52].
Diagnosis of postransfusional iron overload:
• Established
– Ferritin
– Liver iron concentration (biopsy)
• Investigational
– Biomagnetic liver susceptometry (SQUID)
– Magnetic resonance imaging (MRI)
Ferritin is inexpensive, noninvasive, and widely available method, which provides reliable estimates of iron burden when performed on a serial basis. Serum ferritin levels consistently >1000 mcg/L are suggestive of iron overload [62, 70], and in the absence of appropriate therapy are associated with adverse clinical outcomes in iron overload [50, 62, 75]. Ferritin is the simplest method for assessment of iron overload, but it has limitations of the value [13]. The advantages and disadvantages of the ferritin measure are summarized
in Table 1.
Advantages | Disadvantages |
|---|---|
• Easy to assess | • Indirect measurement of iron burden |
• Inexpensive | • Fluctuates in response to inflammation, abnormal liver function, metabolic deficiencies |
• Repeat measures are useful for monitoring chelation therapy | • Serial measurement required |
• Positive correlation with morbidity and mortality |
Table 1. Ferritin as a marker of iron overload
Liver biopsy provides direct information about the structure, function, and extent of iron deposition within the liver, and may also have prognostic value.
Liver iron concentration (LIC) predicts total body storage iron [5, 13], but measuring LIC by Liver Biopsy has its limitations, too
(Table 2).
Advantages | Disadvantages |
|---|---|
• Direct measurement of LIC | • Invasive, painful procedure associated with potentially serious complications |
• Validated reference standard | • Risk of sampling error, especially in patients with cirrhosis |
• Quantitative, specific, and sensitive | • Requires skilled physicians and standardized laboratory techniques |
• Allows for measurement of nonhaeme storage iron | • Poorly correlated with cardiac iron |
• Provides information on liver histology/pathology | • Difficult follow-up |
• Positive correlation with morbidity and mortality |
Table 2. LIC as a marker of iron overload
Magnetic resonance imaging (MRI) provides a noninvasive, quantitative method of estimating parenchymal iron levels. In principle, MRI can be used to quantify iron stores wherever they exist in the body. In practice, MRI has been investigated in the assessment of hepatic, cardiac, and anterior pituitary iron stores. MRI measures tissue iron concentration indirectly via the detection of the paramagnetic influences of storage iron (ferritin and haemosiderin) on the proton resonance behavior of tissue water [39]. The longitudinal (R1) and transverse (R2) nuclear magnetic relaxation rates of nearby solvent water protons can then be calculated. Both R1 and R2 rates are increased when interacting with paramagnetic particles such as iron. R2 (or spin-echo imaging) is preferable to R1 for determining LIC, since ferritin enhances the relaxation of both R1 and R2, while haemosiderin only has a strong R2 relaxation accelerating effect. Gradient echo imaging produces images for calculating T2* and R2*, where R2* = 1000/T2*. A T2* of 20 ms is equivalent to an R2* of 50 Hz. MRI provides a non-invasive alternative to liver biopsy, and may actually be more accurate in patients with heterogeneous liver iron deposition (such as those with cirrhosis) since it measures iron in the whole organ. In addition, the pathologic status of the liver can also be assessed using MRI [3, 25, 27]. MRI remains the only noninvasive modality in clinical use with the ability to detect cardiac iron deposition. T2* MRI is rapidly becoming the new standard for measuring cardiac iron levels. One study found that below a myocardial T2* of 20 ms, there was a progressive and significant decline in left ventricular ejection fraction (LVEF). In general, the lower the T2*, the higher the risk of cardiac dysfunction, with a T2* <8 ms suggestive of severe iron overload [3].
SQUID stands for Superconducting Quantum Interference Device. This imaging modality uses a very low-power magnetic field with sensitive detectors that measure the interference of iron within the field. The sensor requires a cryogenic environment, since it must be superconducting to operate. Although SQUID is still considered investigational, linear correlations have been demonstrated between SQUID measurements and liver biopsy LIC levels [14, 16, 59, 66].
Although SQUID directly measures the magnetic susceptibility of ferritin and haemosiderin, at present it does not have sufficient spatial or temporal resolution to evaluate myocardial iron. In a large clinical trial, LIC data obtained by SQUID were shown to underestimate LIC values obtained from biopsy by a factor of 0.46 [64].
Both SQUID and MRI have linear correlations with LIC assessed by biopsy, but they provide indirect measurement of LIC, have high cost and as highly specialized equipment requires dedicated technician [3, 7]. Limitations of these methods are summarized in Table 3.
Method | Advantages | Disadvantages |
|---|---|---|
MRI | Non-invasive | Requires imager with a dedicated imaging method |
SQUID | Non-invasive | Limited availability |
Table 3. SQUID and MRI as a markers of iron overload
Various additional laboratory tests have been developed to assess iron overload. While not widely available, they may hold promise of providing additional clinical information.
• Serum ferritin iron may be less susceptible than serum ferritin to confounding factors such as inflammation [36].
• Serum transferrin receptor concentration has been used to detect both iron deficiency and excess iron. In the presence of iron overload, cells downregulate transferrin receptor expression, and therefore serum transferrin receptor concentration would be expected to be reduced [41].
• Non-transferrin-bound iron (NTBI) - which is normally not found in plasma, increased rapidly during conditioning therapy and contribute to .oxidative stress after high-dose radiochemotherapy [24].
• Labile plasma iron (LPI) quantifies the oxidative activity of the patient's plasma-borne NTBI. In theory, this test can be used as a direct measure of iron overload. One approach to measuring LPI is to measure the reactive radicals generated in the subject's blood by exposure to ascorbate, compared to those generated after the addition of a chelating agent (which blocks the oxidative activity of the NTBI) [26].
• Directly chelatable iron (DCI) is not a test for iron overload per se, but rather an experimental assay for assaying the plasma pool of non-transferrin-bound iron (NTBI).
If to speak about recommendations three guidelines concerning MDS, SCD and thalassemia should be mentioned.
Consensus recommendations developed by leading MDS researchers and clinicians recommend baseline assessment of body iron stores at diagnosis of MDS and at regular intervals – at least every 3 months – thereafter [28]. They recommend that monitoring be performed with a combination of serum ferritin, serum transferrin, and liver MRI [28].
U.S. National Heart, Lung, and Blood Institute (NHLBI) guidelines for the management of sickle cell disease state that, even in patients who receive intermittent transfusions, "a comprehensive program to monitor and treat iron overload is necessary" [56]. NHLBI guidelines state that [56]:
• Screening for iron overload with serum ferritin testing is recommended at the onset of transfusions.
• Iron overload is likely to be detected after 20 transfusions.
• Liver biopsy is the most accurate test for confirming iron overload in SCD.
According to the Thalassaemia International Federation (TIF) Guidelines for Clinical Management, iron overload constitutes "the most important complication in β-thalassemia and the major focus of clinical management") [21].
TIF guidelines recommend screening for iron overload at the onset of transfusions. Iron overload is likely to be detected after the first 10-20 transfusions (near age 3 years) [22]:
• Monitor serum ferritin at least every 3 months
• Do not rely on serum ferritin alone
• Liver iron concentration – determined by biopsy or noninvasively by MRI or SQUID – is the reference standard for estimating iron loading
Thus, summarized these guidelines, it can be recommended for all haematological conditions to accurately evaluate and record the iron input, start screening for iron overload at the time of beginning the initial treatment then after each 10-20 transfusions and every three months. Serum ferritin can be used as the basic parameter, but though it is not highly specific marker, it shouldn’t be used alone. LIC measurement by biopsy (if indicated) or by MRI or SQUID (if available) is desirable. Assessment of the heart iron by MRI T2* (cardiac risk), at least once is also recommended, If positive, it should be used as the main result to set treatment [16].
Iron overload in transplantation setting
Iron overload commonly accompanies bone marrow transplantation [73]. Haematopoetic cell transplant recipients - both allogenic and autologous – often present with iron overload because of exposure to RBC transfusions, both during the initial treatment of their disease and in the post transplant period [48]. Despite these there are some conditions which contribute to increased risk for iron overload: the genetic background (heterozygous C282Y mutations can be identified in ~30% of patients with MDS); chemo/radiotherapy (total body irradiation (TBI)/alkylator-induced alterations which increase NTBI and decrease total radical-trapping antioxidant activity in plasma); chronic infections and inflammation; haemolytic disorders induced by immunosuppressive agents (cyclosporine and tacrolimus) [60]. Even in patients without a history of transfusions, a predictable increase in serum iron, transferring saturation, ferritin and non-transferrin bound iron has been observed in the early post transplantat period [11, 31, 71].
There are several studies concerning importance of iron overload in transplantation setting [9, 20, 35, 47, 53, 60, 69, 73, 76]. The majority of data are devoted to thalassemia and MDS patients. Concerning thalassemia patients hepatomegaly, hepatic fibrosis due to iron overload and poor compliance with iron chelation were identified as being independent prognostic factors, and a classification system according to these factors was developed and adopted by most centers [71]. Age is also an important factor when predicting outcome, with adult patients usually having a poorer outcome when compared to children [44]. In MDS the recently defined WHO classification–based Prognostic Scoring System (WPSS) (which include the transfusion dependency as a prognostic factor) was able to identify five risk groups of untreated MDS patients with different survival and risk of leukaemic progression, compared with the four groups defined by IPSS [32]. It was observed in addition that WPSS has an independent prognostic significance on both overall survival (OS) and probability of relapse in MDS patients undergoing allo-HSCT. This score appeared to improve post transplantation prognostic stratification with respect to the International prognosis scoring system (IPSS). Considering MDS patients without excess of blasts, the WPSS identified two groups of patients (low vs. intermediate risk) with a significant difference in OS and treatment related mortality (TRM), whereas in the same group of patients IPSS failed to stratify the prognosis [49]. Interestingly, both WHO classification and WPSS maintained their prognostic effect on post transplantation outcome also in specific subsets of patients, such as patients older than 50 years as well as patients receiving reduce intensity chemotherapy (RIC). This observation might be relevant in the light of the increased number of RIC performed in MDS in most recent years, after the demonstration of their efficacy in allowing engraftment and in decreasing TRM in patients ineligible for standard conditioning allo-HSCT [49]. In particular, WHO classification and WPSS show a relevant prognostic value in post transplantation outcome of MDS patients and might help decision making in transplantation.
Armand et al. estimated that iron overload could be a significant contributor to TRM for patients with haematologic malignancies undergoing HSCT. They studied 590 patients who underwent myeloablative allogeneic HSCT at their institution, and on whom pre-transplantation serum ferritin was available. An elevated pretransplantation serum ferritin level was strongly associated with lower OS and DFS. Subgroup multivariable analyses demonstrated that this association was restricted to patients with acute leukemia or MDS [9].
Altes et al. concluded that very high level (VHL) of ferritin and transferring saturation (TS) >/=100% at the time of conditioning are associated with an increase in toxic deaths after transplant [2].
Several other studies also confirm that iron overload can increase morbidity and mortality in transplanted patients [9, 20, 35, 47, 53, 60, 71, 73, 76].
Early and late complications of HCT that have been associated with iron overload are summarized in Table 4.
Complication | Comments |
|---|---|
Early (<1 year) post transplant Acute GVHD Hepatic sinusoidal obstruction syndrome |
Mucormycosis, invasive aspergillosis, Listeria monocytogenes and other infections |
Late (>1 year) post transplant |
Mucormycosis, invasive aspergillosis, and other infections |
Table 4. Iron overload-related complications after HSCT [43]
A variety of early post transplantant complications including infections, liver function abnormalities, and the hepatic sinusoidal obstruction syndrome have been connected with iron overload [35, 38, 47, 53, 54, 76].
The late morbidity of iron overload is primarily due to involvement of heart and liver. Although iron-related liver function abnormalities have been reported, there are no studies describing the role of iron overload in late onset of cardiomyopathy and hepatic fibrosis in patients transplanted for diseases other than thalassemia [1, 8, 15, 42, 61, 80]. Iron overload has been reported to increase the risk of infections late after transplantation. The impact of iron overload on long-term nonrelapse mortality has not been studied. Iron overload can mimic liver GVHD. Whether it can increase the risk of GVHD is an open question and more investigations are required to confirm this idea [48].
Iron chelation therapy
The principal goal of chelation therapy is to decrease tissue iron concentrations to lower levels without risk of iron-mediated toxicity. Guidelines for iron overload treatment in MDS patients (IPSS low or intermediate-I, stable disease, candidates for allograft) recommend starting chelation therapy after receiving 20 units of red blood cell transfusions and clinical evidence of chronic iron overload (serum ferritin levels > 1000 μg/L or liver ferritin < 2 mg/g dry weight) [28]. TIF guidelines also recommend managing iron overload when serum ferritin is >1000 mcg/L [21, 22]. NIH recommends start iron chelation in SCD patients when liver iron stores rise to 7 mg/g dry weight; cumulative transfusion of 120 cc of pure red cells/kg body weight and serum ferritin level in steady-state is >1000 ng/mL [57].
There are no clear-cut guidelines for when to start screen and initiate therapy for iron overload in transplanted patients. End-organ damage related to iron overload is dependent on the rate of iron accumulation and the period of overload state. HSCT recipients frequently get RBC transfusions during their treatment and in the early post transplant period. Decisions regarding management of iron overload should be individualized and be based on several factors including the need of transfusion therapy, time since transplantation, and urgency to reduce body iron stores which is dependent on the presence of liver tests abnormalities or cardiac dysfunction. According to those studies which estimated the role of iron overload on complications and mortality after transplantation, screening and treatment of iron overload might have to be considered in the pre-transplant and early post transplant period. Many patients become transfusion independent with time and if having mild iron overload without signs of organ damage, can be observed without any treatment. There are published recommendations for screening and prevention of late effects of iron overload in HSCT which suggest to monitor the ferritin level at one year post transplant [69].
The treatment modalities for iron overload are summarized in Table 5.
Treatment modality | Administration |
|---|---|
Phlebotomy | 7 ml/kg body weight weekly |
Desferrioxamine (Desferal) | 8–12 hours subcutaneous infusion 5–7 days per week; dose, infusion duration, and number of administrations to be decided according to patient age and severity of iron overload |
Deferasirox (Exjade) | Once-daily oral dosing; initial daily dose of 20 mg/kg (10–30 mg/kg) |
Deferiprone (Ferriprox) | Twice-daily oral dosing; total daily dose of 75 mg/kg |
Table 5. Treatment modalities for iron overload
Phlebotomy is a feasible and effective method of iron overload treatment. Its efficacy was demonstrated in many studies [5, 6, 40, 53], but patients with persisting anemia are not able to undergo phlebotomy. Although the use of erytropoiesis stimulating agents to enable phlebotomy has been reported following HSCT, caution should be performed in their use because of recent reports of an increased risk of thromboembolism [10, 68]. Patients not being eligible for phlebotomy can be treated with iron chelators. Deferoxamine (Desferal, Novartis Pharmaceuticals Corporation, USA) has a proven efficacy and safety with decades of experience and has been studied in HCT recipients [29, 30]. The main disadvantages are side effects such as ototoxicity, growth retardation and the inconvenient administration (prolonged daily subcutaneous infusion for 5-7 days) which often leads to poor compliance. Deferiprone is an oral iron chelator, but is not available in all countries, including the Russian Federation, and has not been investigated in HSCT recipients. Deferasirox (Exjad, Novartis Pharmaceuticals Corporation) is a recently introduced oral iron chelator with efficacy similar to deferoxamine [18, 65, 79]. Commonly reported side effects include skin rash, nausea, vomiting and elevation in serum creatinine level. Most of them are mild to moderate and dose-dependent. More experience with its use in HSCT recipients is also needed.
Two iron chelators are currently in earlier stages of clinical trials. Attaching deferoxamine to hydroxyethyl starch creates a high molecular weight compound with a longer circulation time. Studies are underway to seek a dose that would allow acceptable intervals between intravenous infusions while still promoting an effective level of iron excretion. Deferitrin is an orally active tridentate compound from the ferrithiocin class of chelators. Phase I and II studies have not shown evidence of renal toxicity that had been noted in animal studies with some ferrithiocin analogues, and a current dose-escalation study is designed to identify the appropriate strategy for a pivotal trial [23].
Conclusions
1. Disturbed iron balance is a common condition in the patients undergoing intensive chemotherapy, HSCT and multiple RBC transfusions.
2. Iron overload is a subject to iron-chelating therapy because of its negative influence on early postrtansplant complications and even mortality.
3. Although there are no clear guidelines for iron overload screening in HSCT recipients it can be recommended to monitor at least the ferritin level before the transplantation and at one year post transplant.
4. Decision on when to treat must be individualized and depends on transfusion history, ferritin levels, and signs of organ iron toxicity.
5. More studies are needed to better define the natural history of iron overload and its impact on late morbidity and mortality in transplant recipient.
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75. Takatoku M, Takashi U, Shinichiro O, Kanakura O, Sawada K, Tomonaga M, Nakao S, Nakahata T, Harada M, et al. Retrospective nationwide survey of Japanese patients with transfusion-dependent MDS and aplastic anemia highlights the negative impact of iron overload on morbidity/mortality. European Journal of Haematology. 2007;78(6):487-494.
77. Townsend A, Drakesmith H. Role of HFE in iron metabolism, hereditary haemochromatosis, anaemia of chronic disease, and secondary iron overload. Lancet. 2002;359:786-790. doi: 10.1016/S0140-6736(02)07885-6.
80. Zurlo M.F, DeStefano P, Borgna-Pignatti C. Survival and causes of death in thalassaemia major. Lancet. 1989;2:27-30.
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Introduction
Iron is an essential microelement in human body [17]. It is quite important co-factor of enzymes active in mitochondrial respiratory chain, citrate cycle, DNA synthesis, and plays a central role in oxygen binding to hemoglobin and myoglobin; iron-containing proteins are indispensable for collagen, tyrosine and catecholamine metabolism. But free, non-chelated iron, due to its catalytic action in a redox-reaction may form dangerous hydroxyl radicals that may cause cell death resulting from peroxidative damage of cell membranes. In the course of evolutionary development, this was resolved by formation of specialized molecules adapted to its intestinal absorption from food, its transport and deposition in soluble, non-toxic form.
Three crucial mechanisms are important for iron homeostasis, as follows:
• Iron absorption from food products in small intestine which, generally, compensates for physiological losses;
• IRE/IRP (Iron Responsive Element/Iron Regulatory Protein) system means intracellular iron uptake or its deposition in complex with ferritin. These processes provide cellular demands of iron and, at the same time, preventing toxic effect of iron overload;
• Erythrophagocytosis and recirculation of erythrocyte-derived iron, thus ensuring main requirements for iron during erythropoiesis.
These three mechanisms provide stabilization of iron stores in the organism, as well as its intracellular metabolism and bioavailability [17, 34].
The key point of intestinal iron absorption is hepcidin-mediated regulation system. Hepcidin, a peptide hormone made in the liver, is the principal regulator of systemic iron homeostasis. Hepcidin controls plasma iron concentration and tissue distribution of iron by inhibiting intestinal iron absorption, iron recycling by macrophages, and iron mobilization from hepatic stores. Hepcidin acts by inhibiting cellular iron efflux through binding to and inducing the degradation of ferroportin, the sole known cellular iron exporter. Synthesis of hepcidin is homeostatically increased by iron loading and decreased by anemia and hypoxia. Hepcidin is also elevated during infections and inflammation, causing a decrease in serum iron levels and contributing to the development of anemia of inflammation, probably as a host defense mechanism to limit the availability of iron to invading microorganisms [58].
Disorders associated with altered iron metabolism may be arbitrarily classified in two large groups: iron-deficient and iron overload states.
Iron deficiencies may be caused by alimentary factors (low amount of iron in food), increased iron losses (e.g., due to bleedings) and disturbed iron absorption (Crohn’s or celiac disease, surgical removal of part of intestine, the use of some medications etc).
The most common reasons for conditions, associated with iron overload, are as follows [60, 74]:
1. Genetic alterations of iron metabolism
• Hereditary haemochromatosis types 1-4
|
HFE-associated HH (type 1) |
|
C282Y homozygosity |
|
C282Y/H63D compound heterozygosity |
|
Non-HFE-associated HH |
|
Type 2A HJV variants |
|
Type 2B hepcidin variants |
|
Type 3 TfR variants |
|
Type 4 ferroportin variants |
• Acoeruloplasminaemia
• Atransferrinaemia
2. Genetic disturbances of erythropoiesis, and/or life cycle of red blood cells (hereditary dyserythropoietic, haemolytic anaemias, including thalassemias, sickle cell anaemia (SCA), Blakmond-Diamond anaemia)
3. Acquired conditions requiring long-term, repeated haemotransfusions (myelodysplastic syndrome (MDS), acute leukaemias, myelofibrosis, multiple myeloma etc)
4. Chronic liver diseases (hepatitis, alcohol abuse, nonalcoholic steatohepatitis etc)
Transfusion-associated iron overload
Iron overload due to RBC transfusions is a relatively common complication related to long-term treatment of various haematological diseases. Each unit of blood contains 200 mg of haeme iron, more than 100-fold than a daily amount of iron normally absorbed from the diet. Transfused red blood cells, upon their senescence, are degraded and their iron is re-utilized by resident macrophages. These fractions of bioavailable iron, after binding to transferring, are released into the circulation, and dissipate to body tissues. Iron overload is an inevitable consequence of regular transfusion therapy [37]. After receiving 20 lifetime units of packed red blood cells, patients can become iron overloaded. No matter how many years pass between transfusions, the dangers are the same, because the body has no way actively excrete excess iron. Iron overload is proportional to transfusion burden [67, 57].
When iron overload is evident, transferrin becomes saturated, thus leading to increased non-transferrin bound iron (NTBI) in blood plasma. Whereas tissue uptake of transferrin-bound iron is regulated by expression of membrane-bound transferrin receptor (responsible for transport of transferrin into cells [4]), excess of NTBI is often absorbed by susceptible tissues. This leads to pools of unbound iron within cells, which mediate toxicity by the formation of reactive oxygen species (ROS) [30]; Figure 1.
Figure 1.
ROS react with cellular components such as the plasma membrane, lysosomes, and organelle membranes, leading to cellular leakage, dysfunction, and, ultimately, cell death [33].
The organ damage that occurs with transfusional iron overload is similar to that seen in hereditary haemochromatosis, although iron accumulation occurs more rapidly, and deposition of iron in resident tissue macrophages is proportionally greater [43, 74, 77]. Hereditary haemochromatosis is characterized by iron accumulation primarily in the liver, heart, and pancreas. However, whereas chronic anaemias are related to errors in erythropoiesis, the main cause of haemochromatosis is a reduction or absence in expression of hepcidin (in particular, due to the haemochromatosis gene (HFE) mutations) [43, 74, 77].
Under steady-state conditions, hepcidin prevents excessive intestinal absorption of iron and its release from macrophages. Therefore it minimizes the amount of iron that enters into plasma. However, in conditions of chronic iron overload, blood transfusion leads to an increase in erythrocytes, which are broken down by macrophages. This initially results in an increase in iron levels in resident tissue macrophages. Hepcidin expression also downregulates iron release from this system, leading to a “build-up” in the reticuloendothelial system and its possible saturation (a stage that is reduced or absent in patients with haemochromatosis). Subsequently, iron is deposited in various tissues, thus leading to tissue damage [43, 46, 63].
It is well established that, prior to advent of iron-chelating therapy, cardiomyopathy and liver fibrosis associated with iron overload were among the leading causes of death among children with thalassemia [15, 61]. The role of iron overload in MDS patients is also well established. There are different data concerning overall survival and progression free survival in MDS patients according to transfusion dependency and serum ferritin level [49, 50, 51, 75, 78]. Studies have indicated that iron overload following RBC transfusions was an independent, adverse prognostic factor for overall survival (OS) and leukemia-free survival (LFS): OS and LFS were significantly shorter in transfusion-dependent patients with MDS than in those who were not transfusion dependent.
Accurate assessment of body iron burden is necessary to diagnose iron overload and also to effectively manage therapy.
Assessment of body iron stores
There are numerous methods available for the detection and assessment of iron levels, both as total body and specific tissue levels. Because transfusions may lead to rapid iron accumulation, monitoring a patient's number of transfused blood units, serum ferritin levels, and/or liver iron concentrations can play an essential role in the management of iron overload. Each method is associated with advantages and disadvantages [19, 52].
Diagnosis of postransfusional iron overload:
• Established
– Ferritin
– Liver iron concentration (biopsy)
• Investigational
– Biomagnetic liver susceptometry (SQUID)
– Magnetic resonance imaging (MRI)
Ferritin is inexpensive, noninvasive, and widely available method, which provides reliable estimates of iron burden when performed on a serial basis. Serum ferritin levels consistently >1000 mcg/L are suggestive of iron overload [62, 70], and in the absence of appropriate therapy are associated with adverse clinical outcomes in iron overload [50, 62, 75]. Ferritin is the simplest method for assessment of iron overload, but it has limitations of the value [13]. The advantages and disadvantages of the ferritin measure are summarized
in Table 1.
Advantages | Disadvantages |
|---|---|
• Easy to assess | • Indirect measurement of iron burden |
• Inexpensive | • Fluctuates in response to inflammation, abnormal liver function, metabolic deficiencies |
• Repeat measures are useful for monitoring chelation therapy | • Serial measurement required |
• Positive correlation with morbidity and mortality |
Table 1. Ferritin as a marker of iron overload
Liver biopsy provides direct information about the structure, function, and extent of iron deposition within the liver, and may also have prognostic value.
Liver iron concentration (LIC) predicts total body storage iron [5, 13], but measuring LIC by Liver Biopsy has its limitations, too
(Table 2).
Advantages | Disadvantages |
|---|---|
• Direct measurement of LIC | • Invasive, painful procedure associated with potentially serious complications |
• Validated reference standard | • Risk of sampling error, especially in patients with cirrhosis |
• Quantitative, specific, and sensitive | • Requires skilled physicians and standardized laboratory techniques |
• Allows for measurement of nonhaeme storage iron | • Poorly correlated with cardiac iron |
• Provides information on liver histology/pathology | • Difficult follow-up |
• Positive correlation with morbidity and mortality |
Table 2. LIC as a marker of iron overload
Magnetic resonance imaging (MRI) provides a noninvasive, quantitative method of estimating parenchymal iron levels. In principle, MRI can be used to quantify iron stores wherever they exist in the body. In practice, MRI has been investigated in the assessment of hepatic, cardiac, and anterior pituitary iron stores. MRI measures tissue iron concentration indirectly via the detection of the paramagnetic influences of storage iron (ferritin and haemosiderin) on the proton resonance behavior of tissue water [39]. The longitudinal (R1) and transverse (R2) nuclear magnetic relaxation rates of nearby solvent water protons can then be calculated. Both R1 and R2 rates are increased when interacting with paramagnetic particles such as iron. R2 (or spin-echo imaging) is preferable to R1 for determining LIC, since ferritin enhances the relaxation of both R1 and R2, while haemosiderin only has a strong R2 relaxation accelerating effect. Gradient echo imaging produces images for calculating T2* and R2*, where R2* = 1000/T2*. A T2* of 20 ms is equivalent to an R2* of 50 Hz. MRI provides a non-invasive alternative to liver biopsy, and may actually be more accurate in patients with heterogeneous liver iron deposition (such as those with cirrhosis) since it measures iron in the whole organ. In addition, the pathologic status of the liver can also be assessed using MRI [3, 25, 27]. MRI remains the only noninvasive modality in clinical use with the ability to detect cardiac iron deposition. T2* MRI is rapidly becoming the new standard for measuring cardiac iron levels. One study found that below a myocardial T2* of 20 ms, there was a progressive and significant decline in left ventricular ejection fraction (LVEF). In general, the lower the T2*, the higher the risk of cardiac dysfunction, with a T2* <8 ms suggestive of severe iron overload [3].
SQUID stands for Superconducting Quantum Interference Device. This imaging modality uses a very low-power magnetic field with sensitive detectors that measure the interference of iron within the field. The sensor requires a cryogenic environment, since it must be superconducting to operate. Although SQUID is still considered investigational, linear correlations have been demonstrated between SQUID measurements and liver biopsy LIC levels [14, 16, 59, 66].
Although SQUID directly measures the magnetic susceptibility of ferritin and haemosiderin, at present it does not have sufficient spatial or temporal resolution to evaluate myocardial iron. In a large clinical trial, LIC data obtained by SQUID were shown to underestimate LIC values obtained from biopsy by a factor of 0.46 [64].
Both SQUID and MRI have linear correlations with LIC assessed by biopsy, but they provide indirect measurement of LIC, have high cost and as highly specialized equipment requires dedicated technician [3, 7]. Limitations of these methods are summarized in Table 3.
Method | Advantages | Disadvantages |
|---|---|---|
MRI | Non-invasive | Requires imager with a dedicated imaging method |
SQUID | Non-invasive | Limited availability |
Table 3. SQUID and MRI as a markers of iron overload
Various additional laboratory tests have been developed to assess iron overload. While not widely available, they may hold promise of providing additional clinical information.
• Serum ferritin iron may be less susceptible than serum ferritin to confounding factors such as inflammation [36].
• Serum transferrin receptor concentration has been used to detect both iron deficiency and excess iron. In the presence of iron overload, cells downregulate transferrin receptor expression, and therefore serum transferrin receptor concentration would be expected to be reduced [41].
• Non-transferrin-bound iron (NTBI) - which is normally not found in plasma, increased rapidly during conditioning therapy and contribute to .oxidative stress after high-dose radiochemotherapy [24].
• Labile plasma iron (LPI) quantifies the oxidative activity of the patient's plasma-borne NTBI. In theory, this test can be used as a direct measure of iron overload. One approach to measuring LPI is to measure the reactive radicals generated in the subject's blood by exposure to ascorbate, compared to those generated after the addition of a chelating agent (which blocks the oxidative activity of the NTBI) [26].
• Directly chelatable iron (DCI) is not a test for iron overload per se, but rather an experimental assay for assaying the plasma pool of non-transferrin-bound iron (NTBI).
If to speak about recommendations three guidelines concerning MDS, SCD and thalassemia should be mentioned.
Consensus recommendations developed by leading MDS researchers and clinicians recommend baseline assessment of body iron stores at diagnosis of MDS and at regular intervals – at least every 3 months – thereafter [28]. They recommend that monitoring be performed with a combination of serum ferritin, serum transferrin, and liver MRI [28].
U.S. National Heart, Lung, and Blood Institute (NHLBI) guidelines for the management of sickle cell disease state that, even in patients who receive intermittent transfusions, "a comprehensive program to monitor and treat iron overload is necessary" [56]. NHLBI guidelines state that [56]:
• Screening for iron overload with serum ferritin testing is recommended at the onset of transfusions.
• Iron overload is likely to be detected after 20 transfusions.
• Liver biopsy is the most accurate test for confirming iron overload in SCD.
According to the Thalassaemia International Federation (TIF) Guidelines for Clinical Management, iron overload constitutes "the most important complication in β-thalassemia and the major focus of clinical management") [21].
TIF guidelines recommend screening for iron overload at the onset of transfusions. Iron overload is likely to be detected after the first 10-20 transfusions (near age 3 years) [22]:
• Monitor serum ferritin at least every 3 months
• Do not rely on serum ferritin alone
• Liver iron concentration – determined by biopsy or noninvasively by MRI or SQUID – is the reference standard for estimating iron loading
Thus, summarized these guidelines, it can be recommended for all haematological conditions to accurately evaluate and record the iron input, start screening for iron overload at the time of beginning the initial treatment then after each 10-20 transfusions and every three months. Serum ferritin can be used as the basic parameter, but though it is not highly specific marker, it shouldn’t be used alone. LIC measurement by biopsy (if indicated) or by MRI or SQUID (if available) is desirable. Assessment of the heart iron by MRI T2* (cardiac risk), at least once is also recommended, If positive, it should be used as the main result to set treatment [16].
Iron overload in transplantation setting
Iron overload commonly accompanies bone marrow transplantation [73]. Haematopoetic cell transplant recipients - both allogenic and autologous – often present with iron overload because of exposure to RBC transfusions, both during the initial treatment of their disease and in the post transplant period [48]. Despite these there are some conditions which contribute to increased risk for iron overload: the genetic background (heterozygous C282Y mutations can be identified in ~30% of patients with MDS); chemo/radiotherapy (total body irradiation (TBI)/alkylator-induced alterations which increase NTBI and decrease total radical-trapping antioxidant activity in plasma); chronic infections and inflammation; haemolytic disorders induced by immunosuppressive agents (cyclosporine and tacrolimus) [60]. Even in patients without a history of transfusions, a predictable increase in serum iron, transferring saturation, ferritin and non-transferrin bound iron has been observed in the early post transplantat period [11, 31, 71].
There are several studies concerning importance of iron overload in transplantation setting [9, 20, 35, 47, 53, 60, 69, 73, 76]. The majority of data are devoted to thalassemia and MDS patients. Concerning thalassemia patients hepatomegaly, hepatic fibrosis due to iron overload and poor compliance with iron chelation were identified as being independent prognostic factors, and a classification system according to these factors was developed and adopted by most centers [71]. Age is also an important factor when predicting outcome, with adult patients usually having a poorer outcome when compared to children [44]. In MDS the recently defined WHO classification–based Prognostic Scoring System (WPSS) (which include the transfusion dependency as a prognostic factor) was able to identify five risk groups of untreated MDS patients with different survival and risk of leukaemic progression, compared with the four groups defined by IPSS [32]. It was observed in addition that WPSS has an independent prognostic significance on both overall survival (OS) and probability of relapse in MDS patients undergoing allo-HSCT. This score appeared to improve post transplantation prognostic stratification with respect to the International prognosis scoring system (IPSS). Considering MDS patients without excess of blasts, the WPSS identified two groups of patients (low vs. intermediate risk) with a significant difference in OS and treatment related mortality (TRM), whereas in the same group of patients IPSS failed to stratify the prognosis [49]. Interestingly, both WHO classification and WPSS maintained their prognostic effect on post transplantation outcome also in specific subsets of patients, such as patients older than 50 years as well as patients receiving reduce intensity chemotherapy (RIC). This observation might be relevant in the light of the increased number of RIC performed in MDS in most recent years, after the demonstration of their efficacy in allowing engraftment and in decreasing TRM in patients ineligible for standard conditioning allo-HSCT [49]. In particular, WHO classification and WPSS show a relevant prognostic value in post transplantation outcome of MDS patients and might help decision making in transplantation.
Armand et al. estimated that iron overload could be a significant contributor to TRM for patients with haematologic malignancies undergoing HSCT. They studied 590 patients who underwent myeloablative allogeneic HSCT at their institution, and on whom pre-transplantation serum ferritin was available. An elevated pretransplantation serum ferritin level was strongly associated with lower OS and DFS. Subgroup multivariable analyses demonstrated that this association was restricted to patients with acute leukemia or MDS [9].
Altes et al. concluded that very high level (VHL) of ferritin and transferring saturation (TS) >/=100% at the time of conditioning are associated with an increase in toxic deaths after transplant [2].
Several other studies also confirm that iron overload can increase morbidity and mortality in transplanted patients [9, 20, 35, 47, 53, 60, 71, 73, 76].
Early and late complications of HCT that have been associated with iron overload are summarized in Table 4.
Complication | Comments |
|---|---|
Early (<1 year) post transplant Acute GVHD Hepatic sinusoidal obstruction syndrome |
Mucormycosis, invasive aspergillosis, Listeria monocytogenes and other infections |
Late (>1 year) post transplant |
Mucormycosis, invasive aspergillosis, and other infections |
Table 4. Iron overload-related complications after HSCT [43]
A variety of early post transplantant complications including infections, liver function abnormalities, and the hepatic sinusoidal obstruction syndrome have been connected with iron overload [35, 38, 47, 53, 54, 76].
The late morbidity of iron overload is primarily due to involvement of heart and liver. Although iron-related liver function abnormalities have been reported, there are no studies describing the role of iron overload in late onset of cardiomyopathy and hepatic fibrosis in patients transplanted for diseases other than thalassemia [1, 8, 15, 42, 61, 80]. Iron overload has been reported to increase the risk of infections late after transplantation. The impact of iron overload on long-term nonrelapse mortality has not been studied. Iron overload can mimic liver GVHD. Whether it can increase the risk of GVHD is an open question and more investigations are required to confirm this idea [48].
Iron chelation therapy
The principal goal of chelation therapy is to decrease tissue iron concentrations to lower levels without risk of iron-mediated toxicity. Guidelines for iron overload treatment in MDS patients (IPSS low or intermediate-I, stable disease, candidates for allograft) recommend starting chelation therapy after receiving 20 units of red blood cell transfusions and clinical evidence of chronic iron overload (serum ferritin levels > 1000 μg/L or liver ferritin < 2 mg/g dry weight) [28]. TIF guidelines also recommend managing iron overload when serum ferritin is >1000 mcg/L [21, 22]. NIH recommends start iron chelation in SCD patients when liver iron stores rise to 7 mg/g dry weight; cumulative transfusion of 120 cc of pure red cells/kg body weight and serum ferritin level in steady-state is >1000 ng/mL [57].
There are no clear-cut guidelines for when to start screen and initiate therapy for iron overload in transplanted patients. End-organ damage related to iron overload is dependent on the rate of iron accumulation and the period of overload state. HSCT recipients frequently get RBC transfusions during their treatment and in the early post transplant period. Decisions regarding management of iron overload should be individualized and be based on several factors including the need of transfusion therapy, time since transplantation, and urgency to reduce body iron stores which is dependent on the presence of liver tests abnormalities or cardiac dysfunction. According to those studies which estimated the role of iron overload on complications and mortality after transplantation, screening and treatment of iron overload might have to be considered in the pre-transplant and early post transplant period. Many patients become transfusion independent with time and if having mild iron overload without signs of organ damage, can be observed without any treatment. There are published recommendations for screening and prevention of late effects of iron overload in HSCT which suggest to monitor the ferritin level at one year post transplant [69].
The treatment modalities for iron overload are summarized in Table 5.
Treatment modality | Administration |
|---|---|
Phlebotomy | 7 ml/kg body weight weekly |
Desferrioxamine (Desferal) | 8–12 hours subcutaneous infusion 5–7 days per week; dose, infusion duration, and number of administrations to be decided according to patient age and severity of iron overload |
Deferasirox (Exjade) | Once-daily oral dosing; initial daily dose of 20 mg/kg (10–30 mg/kg) |
Deferiprone (Ferriprox) | Twice-daily oral dosing; total daily dose of 75 mg/kg |
Table 5. Treatment modalities for iron overload
Phlebotomy is a feasible and effective method of iron overload treatment. Its efficacy was demonstrated in many studies [5, 6, 40, 53], but patients with persisting anemia are not able to undergo phlebotomy. Although the use of erytropoiesis stimulating agents to enable phlebotomy has been reported following HSCT, caution should be performed in their use because of recent reports of an increased risk of thromboembolism [10, 68]. Patients not being eligible for phlebotomy can be treated with iron chelators. Deferoxamine (Desferal, Novartis Pharmaceuticals Corporation, USA) has a proven efficacy and safety with decades of experience and has been studied in HCT recipients [29, 30]. The main disadvantages are side effects such as ototoxicity, growth retardation and the inconvenient administration (prolonged daily subcutaneous infusion for 5-7 days) which often leads to poor compliance. Deferiprone is an oral iron chelator, but is not available in all countries, including the Russian Federation, and has not been investigated in HSCT recipients. Deferasirox (Exjad, Novartis Pharmaceuticals Corporation) is a recently introduced oral iron chelator with efficacy similar to deferoxamine [18, 65, 79]. Commonly reported side effects include skin rash, nausea, vomiting and elevation in serum creatinine level. Most of them are mild to moderate and dose-dependent. More experience with its use in HSCT recipients is also needed.
Two iron chelators are currently in earlier stages of clinical trials. Attaching deferoxamine to hydroxyethyl starch creates a high molecular weight compound with a longer circulation time. Studies are underway to seek a dose that would allow acceptable intervals between intravenous infusions while still promoting an effective level of iron excretion. Deferitrin is an orally active tridentate compound from the ferrithiocin class of chelators. Phase I and II studies have not shown evidence of renal toxicity that had been noted in animal studies with some ferrithiocin analogues, and a current dose-escalation study is designed to identify the appropriate strategy for a pivotal trial [23].
Conclusions
1. Disturbed iron balance is a common condition in the patients undergoing intensive chemotherapy, HSCT and multiple RBC transfusions.
2. Iron overload is a subject to iron-chelating therapy because of its negative influence on early postrtansplant complications and even mortality.
3. Although there are no clear guidelines for iron overload screening in HSCT recipients it can be recommended to monitor at least the ferritin level before the transplantation and at one year post transplant.
4. Decision on when to treat must be individualized and depends on transfusion history, ferritin levels, and signs of organ iron toxicity.
5. More studies are needed to better define the natural history of iron overload and its impact on late morbidity and mortality in transplant recipient.
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" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["ORGANIZATION_RU"]=> array(36) { ["ID"]=> string(2) "26" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(22) "Организации" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "26" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> NULL ["VALUE"]=> string(0) "" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(0) "" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "13036" ["VALUE"]=> array(2) { ["TEXT"]=> string(2743) "<p>Посттрансфузионная перегрузка железом (ПЖ) является относительно частым осложнением, возникающем при длительном лечении различных гематологических заболеваний. У реципиентов гемопоэтических стволовых клеток (ГСК), как аллогенных, так и аутологичных, часто отмечается ПЖ из-за проведения трансфузий эритроцитов в период первичного лечения и в посттрансплантационном периоде. Кроме того, есть и некоторые состояния, которые приводят к повышенному риску ПЖ. </p> <p>Целый ряд ранних посттрансплантационных осложнений, включая инфекции, нарушения функций печени и синдром обструкции синусоидов печени, связаны с ПЖ. Позднее развитие этого заболевания исходно связано с поражением сердца и печени. Сообщалось о том, что ПЖ повышает риск инфекций в поздние сроки после трансплантации. </p> <p>Предлагается скрининг всех кандидатов на трансплантацию ГСК и всех больных после трансплантации на наличие ПЖ до трансплантации и в различные сроки после нее. Ферритин сыворотки неспецифичен для ПЖ и является плохим прогностическим маркером нагрузки организма железом. Он может быть использован для оценки ПЖ, но его рекомендуется применять вместе с рядом других параметров.</p> <p>Адекватная терапия хелатами может ослабить нагрузку железом и ее осложнения и должна назначаться по мере появления признаков ПЖ. Необходимы дальнейшие исследования для уточнения естественной истории ПЖ и ее вклада в позднюю заболеваемость и смертность у реципиентов после трансплантации. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2695) "Посттрансфузионная перегрузка железом (ПЖ) является относительно частым осложнением, возникающем при длительном лечении различных гематологических заболеваний. У реципиентов гемопоэтических стволовых клеток (ГСК), как аллогенных, так и аутологичных, часто отмечается ПЖ из-за проведения трансфузий эритроцитов в период первичного лечения и в посттрансплантационном периоде. Кроме того, есть и некоторые состояния, которые приводят к повышенному риску ПЖ.
Целый ряд ранних посттрансплантационных осложнений, включая инфекции, нарушения функций печени и синдром обструкции синусоидов печени, связаны с ПЖ. Позднее развитие этого заболевания исходно связано с поражением сердца и печени. Сообщалось о том, что ПЖ повышает риск инфекций в поздние сроки после трансплантации.
Предлагается скрининг всех кандидатов на трансплантацию ГСК и всех больных после трансплантации на наличие ПЖ до трансплантации и в различные сроки после нее. Ферритин сыворотки неспецифичен для ПЖ и является плохим прогностическим маркером нагрузки организма железом. Он может быть использован для оценки ПЖ, но его рекомендуется применять вместе с рядом других параметров.
Адекватная терапия хелатами может ослабить нагрузку железом и ее осложнения и должна назначаться по мере появления признаков ПЖ. Необходимы дальнейшие исследования для уточнения естественной истории ПЖ и ее вклада в позднюю заболеваемость и смертность у реципиентов после трансплантации.
" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(29) "Описание/Резюме" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["DOI"]=> array(36) { ["ID"]=> string(2) "28" ["TIMESTAMP_X"]=> string(19) "2016-04-06 14:11:12" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(3) "DOI" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(3) "DOI" ["DEFAULT_VALUE"]=> string(0) "" ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "80" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "28" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> NULL ["USER_TYPE_SETTINGS"]=> NULL ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "13021" ["VALUE"]=> string(29) "10.3205/ctt-2009-en-000037.01" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(29) "10.3205/ctt-2009-en-000037.01" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(3) "DOI" ["~DEFAULT_VALUE"]=> string(0) "" } ["AUTHOR_EN"]=> array(36) { ["ID"]=> string(2) "37" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:02:59" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(6) "Author" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(9) "AUTHOR_EN" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "37" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "13051" ["VALUE"]=> array(2) { ["TEXT"]=> string(138) "<p class="Autor">M. Ivanova, E. Morozova, Y. Vasilieva, Y. Rudnitskaya, R. Nabiev, L. Zubarovskaya, B. Afanasyev</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(116) "M. Ivanova, E. Morozova, Y. Vasilieva, Y. Rudnitskaya, R. Nabiev, L. Zubarovskaya, B. Afanasyev
" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(6) "Author" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["ORGANIZATION_EN"]=> array(36) { ["ID"]=> string(2) "38" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:02:59" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(12) "Organization" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_EN" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "38" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "13052" ["VALUE"]=> array(2) { ["TEXT"]=> string(169) "<p>Memorial R. M. Gorbacheva Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(157) "Memorial R. M. Gorbacheva Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia
" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Organization" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_EN"]=> array(36) { ["ID"]=> string(2) "39" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:02:59" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(21) "Description / Summary" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_EN" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "39" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "13053" ["VALUE"]=> array(2) { ["TEXT"]=> string(1672) "<p>Posttransfusional iron overload is a relatively common complication related to long-term treatment of various haematological diseases. Haematopoietic stem cell transplant recipients - both allogenic and autologous - often present with iron overload because of exposure to red blood cell (RBC) transfusions during the initial treatment and in the post transplant period. Despite these there are also some conditions which contribute to increased risk for iron overload.</p> <p>A variety of early post transplantant complications including infections, liver function abnormalities, and hepatic sinusoidal obstruction syndrome have been connected with iron overload. The late morbidity of iron overload is primarily due to involvement of heart and liver. Iron overload has been reported to increase the risk of infections late after transplantation. </p> <p>It has been suggested that all candidates for and all survivors of haematopoietic stem cell transplantation HSCT should be screened for iron overload at various time points before and after transplantation. Serum ferritin is sensitive but not specific for iron overload and is a poor predictor of body iron burden. It can be used for iron overload assessment, but it is recommended to use it together with some other parameters. </p> <p>Adequate chelation therapy can reduce iron burden and complications and should be administered as soon as there are signs of iron overload. </p> <p>More studies are needed to better define the natural history of iron overload and its impact on late morbidity and mortality in transplant recipients.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1612) "Posttransfusional iron overload is a relatively common complication related to long-term treatment of various haematological diseases. Haematopoietic stem cell transplant recipients - both allogenic and autologous - often present with iron overload because of exposure to red blood cell (RBC) transfusions during the initial treatment and in the post transplant period. Despite these there are also some conditions which contribute to increased risk for iron overload.
A variety of early post transplantant complications including infections, liver function abnormalities, and hepatic sinusoidal obstruction syndrome have been connected with iron overload. The late morbidity of iron overload is primarily due to involvement of heart and liver. Iron overload has been reported to increase the risk of infections late after transplantation.
It has been suggested that all candidates for and all survivors of haematopoietic stem cell transplantation HSCT should be screened for iron overload at various time points before and after transplantation. Serum ferritin is sensitive but not specific for iron overload and is a poor predictor of body iron burden. It can be used for iron overload assessment, but it is recommended to use it together with some other parameters.
Adequate chelation therapy can reduce iron burden and complications and should be administered as soon as there are signs of iron overload.
More studies are needed to better define the natural history of iron overload and its impact on late morbidity and mortality in transplant recipients.
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A variety of early post transplantant complications including infections, liver function abnormalities, and hepatic sinusoidal obstruction syndrome have been connected with iron overload. The late morbidity of iron overload is primarily due to involvement of heart and liver. Iron overload has been reported to increase the risk of infections late after transplantation.
It has been suggested that all candidates for and all survivors of haematopoietic stem cell transplantation HSCT should be screened for iron overload at various time points before and after transplantation. Serum ferritin is sensitive but not specific for iron overload and is a poor predictor of body iron burden. It can be used for iron overload assessment, but it is recommended to use it together with some other parameters.
Adequate chelation therapy can reduce iron burden and complications and should be administered as soon as there are signs of iron overload.
More studies are needed to better define the natural history of iron overload and its impact on late morbidity and mortality in transplant recipients.
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A variety of early post transplantant complications including infections, liver function abnormalities, and hepatic sinusoidal obstruction syndrome have been connected with iron overload. The late morbidity of iron overload is primarily due to involvement of heart and liver. Iron overload has been reported to increase the risk of infections late after transplantation.
It has been suggested that all candidates for and all survivors of haematopoietic stem cell transplantation HSCT should be screened for iron overload at various time points before and after transplantation. Serum ferritin is sensitive but not specific for iron overload and is a poor predictor of body iron burden. It can be used for iron overload assessment, but it is recommended to use it together with some other parameters.
Adequate chelation therapy can reduce iron burden and complications and should be administered as soon as there are signs of iron overload.
More studies are needed to better define the natural history of iron overload and its impact on late morbidity and mortality in transplant recipients.
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У реципиентов гемопоэтических стволовых клеток (ГСК), как аллогенных, так и аутологичных, часто отмечается ПЖ из-за проведения трансфузий эритроцитов в период первичного лечения и в посттрансплантационном периоде. Кроме того, есть и некоторые состояния, которые приводят к повышенному риску ПЖ. </p> <p>Целый ряд ранних посттрансплантационных осложнений, включая инфекции, нарушения функций печени и синдром обструкции синусоидов печени, связаны с ПЖ. Позднее развитие этого заболевания исходно связано с поражением сердца и печени. Сообщалось о том, что ПЖ повышает риск инфекций в поздние сроки после трансплантации. </p> <p>Предлагается скрининг всех кандидатов на трансплантацию ГСК и всех больных после трансплантации на наличие ПЖ до трансплантации и в различные сроки после нее. Ферритин сыворотки неспецифичен для ПЖ и является плохим прогностическим маркером нагрузки организма железом. Он может быть использован для оценки ПЖ, но его рекомендуется применять вместе с рядом других параметров.</p> <p>Адекватная терапия хелатами может ослабить нагрузку железом и ее осложнения и должна назначаться по мере появления признаков ПЖ. Необходимы дальнейшие исследования для уточнения естественной истории ПЖ и ее вклада в позднюю заболеваемость и смертность у реципиентов после трансплантации. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2695) "Посттрансфузионная перегрузка железом (ПЖ) является относительно частым осложнением, возникающем при длительном лечении различных гематологических заболеваний. У реципиентов гемопоэтических стволовых клеток (ГСК), как аллогенных, так и аутологичных, часто отмечается ПЖ из-за проведения трансфузий эритроцитов в период первичного лечения и в посттрансплантационном периоде. Кроме того, есть и некоторые состояния, которые приводят к повышенному риску ПЖ.
Целый ряд ранних посттрансплантационных осложнений, включая инфекции, нарушения функций печени и синдром обструкции синусоидов печени, связаны с ПЖ. Позднее развитие этого заболевания исходно связано с поражением сердца и печени. Сообщалось о том, что ПЖ повышает риск инфекций в поздние сроки после трансплантации.
Предлагается скрининг всех кандидатов на трансплантацию ГСК и всех больных после трансплантации на наличие ПЖ до трансплантации и в различные сроки после нее. Ферритин сыворотки неспецифичен для ПЖ и является плохим прогностическим маркером нагрузки организма железом. Он может быть использован для оценки ПЖ, но его рекомендуется применять вместе с рядом других параметров.
Адекватная терапия хелатами может ослабить нагрузку железом и ее осложнения и должна назначаться по мере появления признаков ПЖ. Необходимы дальнейшие исследования для уточнения естественной истории ПЖ и ее вклада в позднюю заболеваемость и смертность у реципиентов после трансплантации.
" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(29) "Описание/Резюме" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(2695) "Посттрансфузионная перегрузка железом (ПЖ) является относительно частым осложнением, возникающем при длительном лечении различных гематологических заболеваний. У реципиентов гемопоэтических стволовых клеток (ГСК), как аллогенных, так и аутологичных, часто отмечается ПЖ из-за проведения трансфузий эритроцитов в период первичного лечения и в посттрансплантационном периоде. Кроме того, есть и некоторые состояния, которые приводят к повышенному риску ПЖ.
Целый ряд ранних посттрансплантационных осложнений, включая инфекции, нарушения функций печени и синдром обструкции синусоидов печени, связаны с ПЖ. Позднее развитие этого заболевания исходно связано с поражением сердца и печени. Сообщалось о том, что ПЖ повышает риск инфекций в поздние сроки после трансплантации.
Предлагается скрининг всех кандидатов на трансплантацию ГСК и всех больных после трансплантации на наличие ПЖ до трансплантации и в различные сроки после нее. Ферритин сыворотки неспецифичен для ПЖ и является плохим прогностическим маркером нагрузки организма железом. Он может быть использован для оценки ПЖ, но его рекомендуется применять вместе с рядом других параметров.
Адекватная терапия хелатами может ослабить нагрузку железом и ее осложнения и должна назначаться по мере появления признаков ПЖ. Необходимы дальнейшие исследования для уточнения естественной истории ПЖ и ее вклада в позднюю заболеваемость и смертность у реципиентов после трансплантации.
" } } } [3]=> array(49) { ["IBLOCK_SECTION_ID"]=> string(2) "39" ["~IBLOCK_SECTION_ID"]=> string(2) "39" ["ID"]=> string(3) "940" ["~ID"]=> string(3) "940" ["IBLOCK_ID"]=> string(1) "2" ["~IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(300) "Оценка факторов, влияющих на эффективность мобилизации гемопоэтических стволовых клеток периферической крови у пациентов с гемобластозами и солидными опухолями" ["~NAME"]=> string(300) "Оценка факторов, влияющих на эффективность мобилизации гемопоэтических стволовых клеток периферической крови у пациентов с гемобластозами и солидными опухолями" ["ACTIVE_FROM"]=> NULL ["~ACTIVE_FROM"]=> NULL ["TIMESTAMP_X"]=> string(22) "06/20/2017 03:09:34 pm" ["~TIMESTAMP_X"]=> string(22) "06/20/2017 03:09:34 pm" ["DETAIL_PAGE_URL"]=> string(133) "/en/archive/tom-1-nomer-3/stati/otsenka-faktorov-vliyayushchikh-na-effektivnost-mobilizatsii-gemopoeticheskikh-stvolovykh-kletok-per/" ["~DETAIL_PAGE_URL"]=> string(133) "/en/archive/tom-1-nomer-3/stati/otsenka-faktorov-vliyayushchikh-na-effektivnost-mobilizatsii-gemopoeticheskikh-stvolovykh-kletok-per/" ["LIST_PAGE_URL"]=> string(12) "/en/archive/" ["~LIST_PAGE_URL"]=> string(12) "/en/archive/" ["DETAIL_TEXT"]=> string(19665) "Introduction
In the early 1990s, PBSC replaced bone marrow as the preferred source of stem cells because of the relative ease of collection, and the faster hematological recovery when compared with bone marrow transplantation (BMT), which in turn leads to fewer complications, and lowers the costs of the procedure [1]. Small but distinct numbers of HSCs are in circulating blood even in the normal steady state, and recruitment of HSCs to peripheral blood following chemotherapy and/or treatment with cytokines, which is termed peripheral blood stem cell (PBSC) mobilization, is necessary and widely used in clinical practice. Currently, high-dose chemotherapy with autologous stem cell transplantation is increasingly used in a wide range of hematological and solid malignancies [3]. Successful autologous peripheral blood stem cell transplantation (ASCT) depends on the infusion of an adequate number of peripheral blood progenitor cells (PBPC). For rapid hematological recovery and durable engraftment, an infusion of a minimum of 2.0 x 106 CD34+ cells per kg of a patient’s body weight (/kg) is required. However, a CD34+ cell dose of 5.0 x 106/kg or greater may be optimal and preferred, as virtually all patients infused with this dose experience hematological recovery within two weeks. The identification of risk factors of poor PBPC collection in patients with hematologic or solid malignancies is of clinical relevance for therapeutic decisions. In recent years, some of the underlying physiology has been elucidated, leading to the development of new mobilization strategies. Expression of the G-CSF receptor on stem cells is not required for mobilization. G-CSF or myelosuppressive therapy acts via secondary pathways, including the chemokine stromal-derived factor-1 and its receptor CXCR4 [4]. A multitude of agents are being developed and tested to be used alone or in combination with G-CSF or chemotherapy in order to successfully remobilize poor mobilizers, reduce the number of apheresis sessions and/or the amount of G-CSF required for successful PBSC mobilization. Furthermore, the combinations and new agents are used to improve the hematopoietic recovery after PBSC transplantation [5]. New chemokine receptor agonists lead to a rapid and substantial PBSC mobilization. A pegylated G-CSF (pegfilgrastim) now has become available. The administration of a single dose of 30–300μg/kg of pegfilgrastim resulted in a significant mobilization of CD34+ cells in tumor patients treated with chemotherapy [6, 7]. The combination of stem cell factor (SCF), a cytokine acting on early stem cells, with G-CSF resulted in improved mobilization in conjunction with reduced apheresis numbers in multiple myeloma patients [8-10]. In 44% of heavily pretreated patients with Hodgkin’s disease or non-Hodgkin’s lymphoma, it resulted in a successful mobilization (5 x 106 CD34+ cells/kg bw) compared with only 17% in the G-CSF group [1]. Significant progress has been made in understanding the mechanisms of PBSC mobilization. This has led to the development of new agents that are already being tested in clinical trials. AMD-3100, a small synthetic molecule and a partial CXCR4 agonist, is the most promising compound in this series [11, 12, 10].
We have retrospectively analyzed data from 121 consecutive patients with malignancies who had undergone PBPC harvests to define the predictive factors that affect the ability to collect an adequate number of PBPC for AHSCT, and the time to reach the target PBSC collection.
Materials and methods
Patients
121 patients undergoing autologous stem cell transplantation between February 2000 and December 2005 were in our center. The patients’ diagnoses, gender, median age, median number of lines of prior chemotherapy, and disease status at transplantation, and the percentage of patients who received prior radiotherapy are listed in Table 1. Patients were enrolled in the study if they were eligible for autologous stem cell transplantation. All patients signed informed concern approved by our local ethics committee.
Table 1. Patient characteristics
PBSC mobilization, harvest and CD34+ cell quantification
100 patients were mobilized with G-CSF alone (Neupogene, Roche, USA) with a dosage of 10μg/kg subcutaneously twice daily. 21 patients received high-dose cyclophosphamide at 4,000 mg/m2. Others were mobilized with various disease-specific chemotherapy regimens that were chosen for both their efficacy against the patients' disease and their ability to induce a WBC rebound following marrow aplasia. The most common chemotherapy regimens were BEACOPP (cyclophospamide, etoposide, doxorubicine, procarbazine, vincristine, bleomycine, prednisolone), dexaBEAM (carmustine, cytarabine, etoposide, dexamethasone, melphalane), and DHAP (cytarabine, cisplatin, dexamethasone). For patients mobilized with cyclophosphamide or other chemotherapy, the first dose of G-CSF was given subcutaneously at a dose of 5 mg/kg/day from the day +5 after chemotherapy had ended, and continued until the day before the last leukapheresis. In all cases the criterion for adequate mobilization was a score of at least 2.0 x 106 CD34+ cells/kg of body weight.
Collection and cryopreservation of PBSCs
PBPC were collected with a continuous-flow blood cell separator (Fenwal CS3000 plus, Baxter healthcare, Deerfield, IL, USA). Each apheresis procedure was performed for approximately 2 to 4 hours, processing 10–14 l of whole blood volume. The total MNC count and CD34+ count of the leukapheresis product was monitored daily following each collection. When the white blood count (WBC) had risen to greater than 1000 cells/μl, the daily peripheral CD34+ count was determined. PBSC collection began when peripheral CD34+ numbers were ≥10 cells/μl. The goal was to collect ≥2.0 x 106 cells CD34+cells per kg of patient weight, which was the criterion for adequate PBPC collection in our study. However, PBPC harvests were discontinued after at least two days from the initiation of leukapheresis when it seemed that they were not likely to yield ≤0.2 x 106 CD34+ cells/kg per day. The cells were cryopreserved according to standard procedure using a Planer programme freezer (UK).
CD34+ cell enumeration
CD34+ cells were enumerated in the peripheral blood and leukapheresis product by using flow cytometry. Briefly, 5 ml aliquots of the samples were incubated for 20 min at room temperature with phycoerythrin (PE)-conjugated monoclonal antibody (moAb) anti-CD34, and fluorescein isothiocyanate (FITC)-conjugated moAb anti-CD45. After incubation, red cells were lysed and washed in phosphate-buffered saline. Cells were analyzed by flow cytometer FACScalibur (Becton Dickinson, San Jose, CA, USA). 100,000 cells were analyzed for each sample.
Response to mobilization
Patients were divided into “good” and “poor” mobilizers. Good mobilizers were defined when ≥2.0 x 106 cells of CD34+ per kg of patient weight could be collected in a maximum of three leukapheresis procedures. Patients who were poor mobilizers needed more than three leukapheresis procedures to collect a number ≤2.0 x 106 cells CD34+ per kg of patient weight, and when a minimum of 10 CD34+ cells/μl was not reached in the peripheral blood after mobilization.
Statistics
The results of the study were analyzed with SPSS 13.0, using parametric and non-parametric methods.
Results
We analyzed 316 mobilization cycles in 121 patients. 104 patients (85%) achieved at least 2.0 x 106 CD 34+ cells/kg of body weight. 17 patients (15%) were poor mobilizers. Data of all patients are summarized in Table 2.
Table 2. Results of HSC mobilization
Influence of diagnosis, gender, and age on PBSC mobilization
In our trial there was no correlation between PBSC yield and the patient’s age. The same was true of gender. There was also no influence on PBSC mobilization kinetics due to their diagnosis.
Influence of bone marrow involvement
The influence of marrow involvement on PBPC mobilization was studied in patients with multiple myeloma and non-Hodgkin lymphomas. We didn’t observe a significant difference in blood levels of CD34+ cells or apheresis yields between patients who didn’t reach complete response of the disease after previous chemotherapy and who had more or less than 50% marrow infiltration at the time of aperesis (data not shown).
Influence of previous cytotoxic chemo- and radiotherapy
A poor mobilization of progenitor cells was observed in patients who had been intensively treated with chemotherapy. Therefore, in those patients who had received a greater number of different chemotherapy regimens prior to harvest, the number of CD34+ cells collected was lower. This was observed when comparing patients who had received 1–5 pre-mobilization cycles of chemotherapy, and patients with more than 5 cycles (p<0.01). Additionally, lower progenitor cell yields were obtained in patients who had received melpalan-containing regimens (miniBEAM, DexaBEAM, melphalan plus prednisolone), than in patients without these characteristics. By contrast, prior radiotherapy wasn’t a significant factor affecting PBPC yield (p=0.5). In previously irradiated patients the mean number of CD34+ cells per apheresis was 5.9 x 106/kg, while in those who did not receive radiation therapy the mean number was 6.4 x 106/kg.
Influence of mobilization regimen
We have studied the effects of G-CSF on chemotherapy-induced stem cell mobilization on peripheral blood and on the yield of stem cell harvest in patients with hematological malignancies. The results of mobilization were much better when using a combination regimen of G-CSF and chemotherapy, than G-CSF alone (p=0.008) (see Table 2).
Conclusion
The number of CD34+ cells transplanted can help predict the speed of engraftment after myeloablative therapy [13]. A subset of patients, often heavily pretreated, do not achieve satisfactory PBSC mobilization [14]. Many studies proved that prior radiotherapy and chemotherapy with alkylating agents (melphalan, carmustine) adversely affect mobilization [15, 16]. Melphalan is particularly stem-cell toxic, and even a low dose given orally before mobilization results in reduced CD34+ cell mobilization [4]. The most negative predictive factor for progenitor cell yield in our study was the extent of prior chemotherapy, as has been described for chemotherapy mobilization [17, 18]. Pretreatment with more than six cycles of chemotherapy resulted in a significantly lower cell harvest than pretreatment with fewer than six cycles (p≤0.0001). We observed that in patients who received more than six cycles of chemotherapy pCD34+ cell count was achieved later and showed a lower maximal height of pCD34+ cells/l PB. This finding agrees with previous studies supporting that PBSC collection should be performed early in the course of disease to avoid CT-induced stem cell damage [4, 14, 18]. Further studies of new mobilization agents (pegylated G-CSF, CXCR-inhibitors) and their combinations are needed to improve the result of stem cell mobilization and to solve the problem of so-called “poor” mobilizers.
References
2. Kobbe G, Sohngen D, Bauser U, Schneider P, Germing U,Thiele KP, Rieth C, Hunerliturkoglu A, Fischer J, Frick M, Wernet P, Aul C, Heyll A. Factors influencing G-CSF-mediated mobilization of hematopoietic progenitor cells during steady-state hematopoiesis in patients with malignant lymphoma and multiple myeloma. Annals of Hematology. 1999;78:456–462.
9. Cashen AF, Link D, Devine S, DiPersio J. Cytokines and stem cell mobilization for autologous and allogeneic transplantation. Curr Hematol Rep. 2004;3:406–412. pmid: 15496273.
10. Montgomery M, Cottler-Fox M. Mobilization and collection of autologous hematopoietic progenitor/stem cells. Clin AdvHematol Oncol. 2007;5:127–136. pmid: 17344802.
12. Goterris R, Hernandez-Boluda JC, Teruel A, Gomez C, Lis MJ, Terol MJ. Impact of different strategies of secondline stem cell harvest on the outcome of autologoustransplantation in poor peripheral blood stem cell mobilizers. Bone Marrow Transplant. 2005;36:847–853. doi: 10.1038/sj.bmt.1705147.
13. Jansen J, Thompson JM, Dugan MJ, et al. Peripheral blood progenitor cell transplantation. Ther Apher. 2002;6:5-14. doi: 10.1046/j.1526-0968.2002.00392.x.
14. Goldschmidt H, Hegenbart U, Wallmeier M, Hohaus S, Haas R. Factors influencing collection of peripheral blood progenitor cells following high-dose cyclophosphamide and granulocyte colony-stimulating factor in patients with multiple myeloma. British Journal of Haematology. 1997;98:736-744. pmid: 9332333.
16. Winkler IG, Levesque JP. Mechanisms of hematopoietic stem cell mobilization: when innate immunity assails the cells that make blood and bone. Exp Hematol. 2006;34:996–1009. doi: 10.1016/j.exphem.2006.04.005.
18. Schiller G, Rosen L, Vescio R, et al. Threshold dose of autologous CD34 positive peripheral blood progenitor cells required for engraftment after myeloablative treatment for multiple myeloma. Blood. 1994;84(suppl 1):813a.
" ["~DETAIL_TEXT"]=> string(19665) "Introduction
In the early 1990s, PBSC replaced bone marrow as the preferred source of stem cells because of the relative ease of collection, and the faster hematological recovery when compared with bone marrow transplantation (BMT), which in turn leads to fewer complications, and lowers the costs of the procedure [1]. Small but distinct numbers of HSCs are in circulating blood even in the normal steady state, and recruitment of HSCs to peripheral blood following chemotherapy and/or treatment with cytokines, which is termed peripheral blood stem cell (PBSC) mobilization, is necessary and widely used in clinical practice. Currently, high-dose chemotherapy with autologous stem cell transplantation is increasingly used in a wide range of hematological and solid malignancies [3]. Successful autologous peripheral blood stem cell transplantation (ASCT) depends on the infusion of an adequate number of peripheral blood progenitor cells (PBPC). For rapid hematological recovery and durable engraftment, an infusion of a minimum of 2.0 x 106 CD34+ cells per kg of a patient’s body weight (/kg) is required. However, a CD34+ cell dose of 5.0 x 106/kg or greater may be optimal and preferred, as virtually all patients infused with this dose experience hematological recovery within two weeks. The identification of risk factors of poor PBPC collection in patients with hematologic or solid malignancies is of clinical relevance for therapeutic decisions. In recent years, some of the underlying physiology has been elucidated, leading to the development of new mobilization strategies. Expression of the G-CSF receptor on stem cells is not required for mobilization. G-CSF or myelosuppressive therapy acts via secondary pathways, including the chemokine stromal-derived factor-1 and its receptor CXCR4 [4]. A multitude of agents are being developed and tested to be used alone or in combination with G-CSF or chemotherapy in order to successfully remobilize poor mobilizers, reduce the number of apheresis sessions and/or the amount of G-CSF required for successful PBSC mobilization. Furthermore, the combinations and new agents are used to improve the hematopoietic recovery after PBSC transplantation [5]. New chemokine receptor agonists lead to a rapid and substantial PBSC mobilization. A pegylated G-CSF (pegfilgrastim) now has become available. The administration of a single dose of 30–300μg/kg of pegfilgrastim resulted in a significant mobilization of CD34+ cells in tumor patients treated with chemotherapy [6, 7]. The combination of stem cell factor (SCF), a cytokine acting on early stem cells, with G-CSF resulted in improved mobilization in conjunction with reduced apheresis numbers in multiple myeloma patients [8-10]. In 44% of heavily pretreated patients with Hodgkin’s disease or non-Hodgkin’s lymphoma, it resulted in a successful mobilization (5 x 106 CD34+ cells/kg bw) compared with only 17% in the G-CSF group [1]. Significant progress has been made in understanding the mechanisms of PBSC mobilization. This has led to the development of new agents that are already being tested in clinical trials. AMD-3100, a small synthetic molecule and a partial CXCR4 agonist, is the most promising compound in this series [11, 12, 10].
We have retrospectively analyzed data from 121 consecutive patients with malignancies who had undergone PBPC harvests to define the predictive factors that affect the ability to collect an adequate number of PBPC for AHSCT, and the time to reach the target PBSC collection.
Materials and methods
Patients
121 patients undergoing autologous stem cell transplantation between February 2000 and December 2005 were in our center. The patients’ diagnoses, gender, median age, median number of lines of prior chemotherapy, and disease status at transplantation, and the percentage of patients who received prior radiotherapy are listed in Table 1. Patients were enrolled in the study if they were eligible for autologous stem cell transplantation. All patients signed informed concern approved by our local ethics committee.
Table 1. Patient characteristics
PBSC mobilization, harvest and CD34+ cell quantification
100 patients were mobilized with G-CSF alone (Neupogene, Roche, USA) with a dosage of 10μg/kg subcutaneously twice daily. 21 patients received high-dose cyclophosphamide at 4,000 mg/m2. Others were mobilized with various disease-specific chemotherapy regimens that were chosen for both their efficacy against the patients' disease and their ability to induce a WBC rebound following marrow aplasia. The most common chemotherapy regimens were BEACOPP (cyclophospamide, etoposide, doxorubicine, procarbazine, vincristine, bleomycine, prednisolone), dexaBEAM (carmustine, cytarabine, etoposide, dexamethasone, melphalane), and DHAP (cytarabine, cisplatin, dexamethasone). For patients mobilized with cyclophosphamide or other chemotherapy, the first dose of G-CSF was given subcutaneously at a dose of 5 mg/kg/day from the day +5 after chemotherapy had ended, and continued until the day before the last leukapheresis. In all cases the criterion for adequate mobilization was a score of at least 2.0 x 106 CD34+ cells/kg of body weight.
Collection and cryopreservation of PBSCs
PBPC were collected with a continuous-flow blood cell separator (Fenwal CS3000 plus, Baxter healthcare, Deerfield, IL, USA). Each apheresis procedure was performed for approximately 2 to 4 hours, processing 10–14 l of whole blood volume. The total MNC count and CD34+ count of the leukapheresis product was monitored daily following each collection. When the white blood count (WBC) had risen to greater than 1000 cells/μl, the daily peripheral CD34+ count was determined. PBSC collection began when peripheral CD34+ numbers were ≥10 cells/μl. The goal was to collect ≥2.0 x 106 cells CD34+cells per kg of patient weight, which was the criterion for adequate PBPC collection in our study. However, PBPC harvests were discontinued after at least two days from the initiation of leukapheresis when it seemed that they were not likely to yield ≤0.2 x 106 CD34+ cells/kg per day. The cells were cryopreserved according to standard procedure using a Planer programme freezer (UK).
CD34+ cell enumeration
CD34+ cells were enumerated in the peripheral blood and leukapheresis product by using flow cytometry. Briefly, 5 ml aliquots of the samples were incubated for 20 min at room temperature with phycoerythrin (PE)-conjugated monoclonal antibody (moAb) anti-CD34, and fluorescein isothiocyanate (FITC)-conjugated moAb anti-CD45. After incubation, red cells were lysed and washed in phosphate-buffered saline. Cells were analyzed by flow cytometer FACScalibur (Becton Dickinson, San Jose, CA, USA). 100,000 cells were analyzed for each sample.
Response to mobilization
Patients were divided into “good” and “poor” mobilizers. Good mobilizers were defined when ≥2.0 x 106 cells of CD34+ per kg of patient weight could be collected in a maximum of three leukapheresis procedures. Patients who were poor mobilizers needed more than three leukapheresis procedures to collect a number ≤2.0 x 106 cells CD34+ per kg of patient weight, and when a minimum of 10 CD34+ cells/μl was not reached in the peripheral blood after mobilization.
Statistics
The results of the study were analyzed with SPSS 13.0, using parametric and non-parametric methods.
Results
We analyzed 316 mobilization cycles in 121 patients. 104 patients (85%) achieved at least 2.0 x 106 CD 34+ cells/kg of body weight. 17 patients (15%) were poor mobilizers. Data of all patients are summarized in Table 2.
Table 2. Results of HSC mobilization
Influence of diagnosis, gender, and age on PBSC mobilization
In our trial there was no correlation between PBSC yield and the patient’s age. The same was true of gender. There was also no influence on PBSC mobilization kinetics due to their diagnosis.
Influence of bone marrow involvement
The influence of marrow involvement on PBPC mobilization was studied in patients with multiple myeloma and non-Hodgkin lymphomas. We didn’t observe a significant difference in blood levels of CD34+ cells or apheresis yields between patients who didn’t reach complete response of the disease after previous chemotherapy and who had more or less than 50% marrow infiltration at the time of aperesis (data not shown).
Influence of previous cytotoxic chemo- and radiotherapy
A poor mobilization of progenitor cells was observed in patients who had been intensively treated with chemotherapy. Therefore, in those patients who had received a greater number of different chemotherapy regimens prior to harvest, the number of CD34+ cells collected was lower. This was observed when comparing patients who had received 1–5 pre-mobilization cycles of chemotherapy, and patients with more than 5 cycles (p<0.01). Additionally, lower progenitor cell yields were obtained in patients who had received melpalan-containing regimens (miniBEAM, DexaBEAM, melphalan plus prednisolone), than in patients without these characteristics. By contrast, prior radiotherapy wasn’t a significant factor affecting PBPC yield (p=0.5). In previously irradiated patients the mean number of CD34+ cells per apheresis was 5.9 x 106/kg, while in those who did not receive radiation therapy the mean number was 6.4 x 106/kg.
Influence of mobilization regimen
We have studied the effects of G-CSF on chemotherapy-induced stem cell mobilization on peripheral blood and on the yield of stem cell harvest in patients with hematological malignancies. The results of mobilization were much better when using a combination regimen of G-CSF and chemotherapy, than G-CSF alone (p=0.008) (see Table 2).
Conclusion
The number of CD34+ cells transplanted can help predict the speed of engraftment after myeloablative therapy [13]. A subset of patients, often heavily pretreated, do not achieve satisfactory PBSC mobilization [14]. Many studies proved that prior radiotherapy and chemotherapy with alkylating agents (melphalan, carmustine) adversely affect mobilization [15, 16]. Melphalan is particularly stem-cell toxic, and even a low dose given orally before mobilization results in reduced CD34+ cell mobilization [4]. The most negative predictive factor for progenitor cell yield in our study was the extent of prior chemotherapy, as has been described for chemotherapy mobilization [17, 18]. Pretreatment with more than six cycles of chemotherapy resulted in a significantly lower cell harvest than pretreatment with fewer than six cycles (p≤0.0001). We observed that in patients who received more than six cycles of chemotherapy pCD34+ cell count was achieved later and showed a lower maximal height of pCD34+ cells/l PB. This finding agrees with previous studies supporting that PBSC collection should be performed early in the course of disease to avoid CT-induced stem cell damage [4, 14, 18]. Further studies of new mobilization agents (pegylated G-CSF, CXCR-inhibitors) and their combinations are needed to improve the result of stem cell mobilization and to solve the problem of so-called “poor” mobilizers.
References
2. Kobbe G, Sohngen D, Bauser U, Schneider P, Germing U,Thiele KP, Rieth C, Hunerliturkoglu A, Fischer J, Frick M, Wernet P, Aul C, Heyll A. Factors influencing G-CSF-mediated mobilization of hematopoietic progenitor cells during steady-state hematopoiesis in patients with malignant lymphoma and multiple myeloma. Annals of Hematology. 1999;78:456–462.
9. Cashen AF, Link D, Devine S, DiPersio J. Cytokines and stem cell mobilization for autologous and allogeneic transplantation. Curr Hematol Rep. 2004;3:406–412. pmid: 15496273.
10. Montgomery M, Cottler-Fox M. Mobilization and collection of autologous hematopoietic progenitor/stem cells. Clin AdvHematol Oncol. 2007;5:127–136. pmid: 17344802.
12. Goterris R, Hernandez-Boluda JC, Teruel A, Gomez C, Lis MJ, Terol MJ. Impact of different strategies of secondline stem cell harvest on the outcome of autologoustransplantation in poor peripheral blood stem cell mobilizers. Bone Marrow Transplant. 2005;36:847–853. doi: 10.1038/sj.bmt.1705147.
13. Jansen J, Thompson JM, Dugan MJ, et al. Peripheral blood progenitor cell transplantation. Ther Apher. 2002;6:5-14. doi: 10.1046/j.1526-0968.2002.00392.x.
14. Goldschmidt H, Hegenbart U, Wallmeier M, Hohaus S, Haas R. Factors influencing collection of peripheral blood progenitor cells following high-dose cyclophosphamide and granulocyte colony-stimulating factor in patients with multiple myeloma. British Journal of Haematology. 1997;98:736-744. pmid: 9332333.
16. Winkler IG, Levesque JP. Mechanisms of hematopoietic stem cell mobilization: when innate immunity assails the cells that make blood and bone. Exp Hematol. 2006;34:996–1009. doi: 10.1016/j.exphem.2006.04.005.
18. Schiller G, Rosen L, Vescio R, et al. Threshold dose of autologous CD34 positive peripheral blood progenitor cells required for engraftment after myeloablative treatment for multiple myeloma. Blood. 1994;84(suppl 1):813a.
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"13244" ["VALUE"]=> array(2) { ["TEXT"]=> string(160) "<p> Алексеев С., Бабенко Е., Эстрина М., Михайлова Н., Зубаровская Л., Афанасьев Б. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(148) "Алексеев С., Бабенко Е., Эстрина М., Михайлова Н., Зубаровская Л., Афанасьев Б.
" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["ORGANIZATION_RU"]=> array(36) { ["ID"]=> string(2) "26" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(22) "Организации" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(15) "ORGANIZATION_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "26" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> NULL ["VALUE"]=> string(0) "" ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> string(0) "" ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(22) "Организации" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } } ["SUMMARY_RU"]=> array(36) { ["ID"]=> string(2) "27" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(29) "Описание/Резюме" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_RU" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "27" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "13245" ["VALUE"]=> array(2) { ["TEXT"]=> string(1970) "<p class="bodytext">Целью мобилизации ГСК является получение не менее 2×10<sup>6</sup> CD34+ клеток на килограмм массы тела реципиента, что принято считать нижним уровнем, позволяющим достичь быстрого и устойчивого приживления трансплантата. Опыт использования Г-КСФ в качестве мобилизующего агента позволил разработать стандартные схемы стимуляции. Тем не менее, у определенной части пациентов при планировании аутологичной трансплантации в ходе стандартной процедуры мобилизации не удается получить достаточного количества ГСК. Плохой ответ или отсутствие ответа на мобилизацию требует проведения последующей ремобилизации и/или дополнительных процедур афереза, что негативно сказывается на состоянии пациента, а также приводит к увеличению экономических затрат.<br /><br />Значительное число пациентов, плохо отвечающих на мобилизацию, делает необходимым анализ факторов, влияющих на эффективность данного процесса. В исследовании проведен анализ клинико-лабораторных данных с целью выявления факторов, оказывающих влияние на результат мобилизации.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1924) "Целью мобилизации ГСК является получение не менее 2×106 CD34+ клеток на килограмм массы тела реципиента, что принято считать нижним уровнем, позволяющим достичь быстрого и устойчивого приживления трансплантата. Опыт использования Г-КСФ в качестве мобилизующего агента позволил разработать стандартные схемы стимуляции. Тем не менее, у определенной части пациентов при планировании аутологичной трансплантации в ходе стандартной процедуры мобилизации не удается получить достаточного количества ГСК. Плохой ответ или отсутствие ответа на мобилизацию требует проведения последующей ремобилизации и/или дополнительных процедур афереза, что негативно сказывается на состоянии пациента, а также приводит к увеличению экономических затрат.
Значительное число пациентов, плохо отвечающих на мобилизацию, делает необходимым анализ факторов, влияющих на эффективность данного процесса. В исследовании проведен анализ клинико-лабораторных данных с целью выявления факторов, оказывающих влияние на результат мобилизации.
Alexeev S., Babenko E., Estrina M., Mikhailova N., Zubarovskaya L., Afanasyev B.
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Patients and methods
121 patients with hematological malignancies and solid tumors were included in the study (Hodgkin’s lymphoma (HD) (n=24), non-Hodgkin lymphomas (NHL) (n=29), multiple myeloma (MM) (n=32), acute leukemias (AL) (n=15), and solid tumors (ST) (n=21)). 100 patients (82%) were mobilized with G-CSF, and a combination of chemotherapy and G-CSF was used in 21 patients (18%). 57 patients (49%) received more than six courses of chemotherapy and 74 (51%) less than six respectively. The criterion for adequate mobilization was a score of at least 2.0 x 106 CD34+ cells/kg of body weight.
In our trial there was no correlation between PBSC yield and the patient’s diagnosis, age, or gender. BM involvement does not seem to be an independent factor, with significant adverse influence on PBSC mobilization (p=0.78). Stem cell yield was significantly higher in those patients who received fewer than six courses of chemotherapy (10.0 ± 2.2 х 106 CD34+/kg against 5.5 ± 1.7 х 106 CD34+/kg (p=0.006)). A better outcome was seen in patients mobilized with chemotherapy plus G-CSF than with G-CSF alone (8.12 ± 1.12 х 106 CD34+/kg against 6.9 ± 0.9 х 106 CD34+/kg (p= 0.008)).
Conclusions
Diagnosis, age, sex, and bone marrow involvement does not influence the outcome of stem cell mobilization. Better stem cell yield was seen in patients who received fewer than six courses of chemotherapy, and in patients mobilized with cytokines combined with chemotherapy than cytokines alone.
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" } ["SUMMARY_EN"]=> array(37) { ["ID"]=> string(2) "39" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:02:59" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(21) "Description / Summary" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(10) "SUMMARY_EN" ["DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["PROPERTY_TYPE"]=> string(1) "S" ["ROW_COUNT"]=> string(1) "1" ["COL_COUNT"]=> string(2) "30" ["LIST_TYPE"]=> string(1) "L" ["MULTIPLE"]=> string(1) "N" ["XML_ID"]=> string(2) "39" ["FILE_TYPE"]=> string(0) "" ["MULTIPLE_CNT"]=> string(1) "5" ["TMP_ID"]=> NULL ["LINK_IBLOCK_ID"]=> string(1) "0" ["WITH_DESCRIPTION"]=> string(1) "N" ["SEARCHABLE"]=> string(1) "N" ["FILTRABLE"]=> string(1) "N" ["IS_REQUIRED"]=> string(1) "N" ["VERSION"]=> string(1) "1" ["USER_TYPE"]=> string(4) "HTML" ["USER_TYPE_SETTINGS"]=> array(1) { ["height"]=> int(200) } ["HINT"]=> string(0) "" ["PROPERTY_VALUE_ID"]=> string(5) "13276" ["VALUE"]=> array(2) { ["TEXT"]=> string(2685) "<p class="bodytext">Mobilized peripheral blood stem cells (PBSC) have become the main source for autologous and allogeneic hemopoietic stem cells transplantation (HSCT) following myeloablative therapy in patients with hematological malignancies or solid tumors. Classical strategies for PBSC mobilization include administration of granulocyte colony-stimulating factor (G-CSF) alone or in combination with other agents or myelosuppressive chemotherapy. PBSC mobilization and collection have been optimized in numerous clinical trials, but a proportion of patients fail to mobilize. The aim of the study was to establish the influence of diagnosis, sex, age, number of previous courses of chemotherapy, mobilization regimen, and bone marrow (BM) involvement on the outcome of peripheral blood stem cell mobilization. </p> <h3>Patients and methods</h3> <p>121 patients with hematological malignancies and solid tumors were included in the study (Hodgkin’s lymphoma (HD) (n=24), non-Hodgkin lymphomas (NHL) (n=29), multiple myeloma (MM) (n=32), acute leukemias (AL) (n=15), and solid tumors (ST) (n=21)). 100 patients (82%) were mobilized with G-CSF, and a combination of chemotherapy and G-CSF was used in 21 patients (18%). 57 patients (49%) received more than six courses of chemotherapy and 74 (51%) less than six respectively. The criterion for adequate mobilization was a score of at least 2.0 x 10<sup>6</sup> CD34+ cells/kg of body weight. </p> <h3Results</h3> <p>In our trial there was no correlation between PBSC yield and the patient’s diagnosis, age, or gender. BM involvement does not seem to be an independent factor, with significant adverse influence on PBSC mobilization (p=0.78). Stem cell yield was significantly higher in those patients who received fewer than six courses of chemotherapy (10.0 ± 2.2 х 10<sup>6</sup> CD<sup>34+</sup>/kg against 5.5 ± 1.7 х 10<sup>6</sup> CD<sup>34+</sup>/kg (p=0.006)). A better outcome was seen in patients mobilized with chemotherapy plus G-CSF than with G-CSF alone (8.12 ± 1.12 х 10<sup>6</sup> CD<sup>34+</sup>/kg against 6.9 ± 0.9 х 10<sup>6</sup> CD<sup>34+</sup>/kg (p= 0.008)).</p><h3>Conclusions</h3> <p>Diagnosis, age, sex, and bone marrow involvement does not influence the outcome of stem cell mobilization. Better stem cell yield was seen in patients who received fewer than six courses of chemotherapy, and in patients mobilized with cytokines combined with chemotherapy than cytokines alone.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2486) "Mobilized peripheral blood stem cells (PBSC) have become the main source for autologous and allogeneic hemopoietic stem cells transplantation (HSCT) following myeloablative therapy in patients with hematological malignancies or solid tumors. Classical strategies for PBSC mobilization include administration of granulocyte colony-stimulating factor (G-CSF) alone or in combination with other agents or myelosuppressive chemotherapy. PBSC mobilization and collection have been optimized in numerous clinical trials, but a proportion of patients fail to mobilize. The aim of the study was to establish the influence of diagnosis, sex, age, number of previous courses of chemotherapy, mobilization regimen, and bone marrow (BM) involvement on the outcome of peripheral blood stem cell mobilization.
Patients and methods
121 patients with hematological malignancies and solid tumors were included in the study (Hodgkin’s lymphoma (HD) (n=24), non-Hodgkin lymphomas (NHL) (n=29), multiple myeloma (MM) (n=32), acute leukemias (AL) (n=15), and solid tumors (ST) (n=21)). 100 patients (82%) were mobilized with G-CSF, and a combination of chemotherapy and G-CSF was used in 21 patients (18%). 57 patients (49%) received more than six courses of chemotherapy and 74 (51%) less than six respectively. The criterion for adequate mobilization was a score of at least 2.0 x 106 CD34+ cells/kg of body weight.
In our trial there was no correlation between PBSC yield and the patient’s diagnosis, age, or gender. BM involvement does not seem to be an independent factor, with significant adverse influence on PBSC mobilization (p=0.78). Stem cell yield was significantly higher in those patients who received fewer than six courses of chemotherapy (10.0 ± 2.2 х 106 CD34+/kg against 5.5 ± 1.7 х 106 CD34+/kg (p=0.006)). A better outcome was seen in patients mobilized with chemotherapy plus G-CSF than with G-CSF alone (8.12 ± 1.12 х 106 CD34+/kg against 6.9 ± 0.9 х 106 CD34+/kg (p= 0.008)).
Conclusions
Diagnosis, age, sex, and bone marrow involvement does not influence the outcome of stem cell mobilization. Better stem cell yield was seen in patients who received fewer than six courses of chemotherapy, and in patients mobilized with cytokines combined with chemotherapy than cytokines alone.
" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(21) "Description / Summary" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(2486) "Mobilized peripheral blood stem cells (PBSC) have become the main source for autologous and allogeneic hemopoietic stem cells transplantation (HSCT) following myeloablative therapy in patients with hematological malignancies or solid tumors. Classical strategies for PBSC mobilization include administration of granulocyte colony-stimulating factor (G-CSF) alone or in combination with other agents or myelosuppressive chemotherapy. PBSC mobilization and collection have been optimized in numerous clinical trials, but a proportion of patients fail to mobilize. The aim of the study was to establish the influence of diagnosis, sex, age, number of previous courses of chemotherapy, mobilization regimen, and bone marrow (BM) involvement on the outcome of peripheral blood stem cell mobilization.
Patients and methods
121 patients with hematological malignancies and solid tumors were included in the study (Hodgkin’s lymphoma (HD) (n=24), non-Hodgkin lymphomas (NHL) (n=29), multiple myeloma (MM) (n=32), acute leukemias (AL) (n=15), and solid tumors (ST) (n=21)). 100 patients (82%) were mobilized with G-CSF, and a combination of chemotherapy and G-CSF was used in 21 patients (18%). 57 patients (49%) received more than six courses of chemotherapy and 74 (51%) less than six respectively. The criterion for adequate mobilization was a score of at least 2.0 x 106 CD34+ cells/kg of body weight.
In our trial there was no correlation between PBSC yield and the patient’s diagnosis, age, or gender. BM involvement does not seem to be an independent factor, with significant adverse influence on PBSC mobilization (p=0.78). Stem cell yield was significantly higher in those patients who received fewer than six courses of chemotherapy (10.0 ± 2.2 х 106 CD34+/kg against 5.5 ± 1.7 х 106 CD34+/kg (p=0.006)). A better outcome was seen in patients mobilized with chemotherapy plus G-CSF than with G-CSF alone (8.12 ± 1.12 х 106 CD34+/kg against 6.9 ± 0.9 х 106 CD34+/kg (p= 0.008)).
Conclusions
Diagnosis, age, sex, and bone marrow involvement does not influence the outcome of stem cell mobilization. Better stem cell yield was seen in patients who received fewer than six courses of chemotherapy, and in patients mobilized with cytokines combined with chemotherapy than cytokines alone.
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В исследовании проведен анализ клинико-лабораторных данных с целью выявления факторов, оказывающих влияние на результат мобилизации.</p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(1924) "Целью мобилизации ГСК является получение не менее 2×106 CD34+ клеток на килограмм массы тела реципиента, что принято считать нижним уровнем, позволяющим достичь быстрого и устойчивого приживления трансплантата. Опыт использования Г-КСФ в качестве мобилизующего агента позволил разработать стандартные схемы стимуляции. Тем не менее, у определенной части пациентов при планировании аутологичной трансплантации в ходе стандартной процедуры мобилизации не удается получить достаточного количества ГСК. Плохой ответ или отсутствие ответа на мобилизацию требует проведения последующей ремобилизации и/или дополнительных процедур афереза, что негативно сказывается на состоянии пациента, а также приводит к увеличению экономических затрат.
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Целью мобилизации ГСК является получение не менее 2×106 CD34+ клеток на килограмм массы тела реципиента, что принято считать нижним уровнем, позволяющим достичь быстрого и устойчивого приживления трансплантата. Опыт использования Г-КСФ в качестве мобилизующего агента позволил разработать стандартные схемы стимуляции. Тем не менее, у определенной части пациентов при планировании аутологичной трансплантации в ходе стандартной процедуры мобилизации не удается получить достаточного количества ГСК. Плохой ответ или отсутствие ответа на мобилизацию требует проведения последующей ремобилизации и/или дополнительных процедур афереза, что негативно сказывается на состоянии пациента, а также приводит к увеличению экономических затрат.
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Research articles
A.A. Novik1, A.N. Kuznetsov1, V.Y. Melnichenko1, D.A. Fedorenko1, T.I. Ionova1, R.V. Kruglina1, A.V. Kartashov1, K.A. Kurbatova1,
G.I. Gorodokin2
N. I. Zubarovskaya, E. V. Semenova, N. V. Stancheva, V. N. Vavilov, I. V. Kazantsev, Yu. G. Vasilieva, N. N. Klimko, B. V. Afanasyev
M. Ivanova, E. Morozova, Y. Vasilieva, Y. Rudnitskaya, R. Nabiev, L. Zubarovskaya, B. Afanasyev
Alexeev S., Babenko E., Estrina M., Mikhailova N., Zubarovskaya L., Afanasyev B.
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[TEXT] => <p class="bodytext">За последние несколько лет высокодозная химиотерапия (ВДХТ) с аутологичной трансплантацией стволовых клеток (ауто-ТГСК) признана методом выбора в терапии больных рассеянным склерозом (РС). Мы сообщаем о клинических и субъективных результатах ВДХТ с ауто-ТГСК у мужчины со вторично-прогрессирующим РС (исходная оценка 5,0 по шкале EDSS). Применялся редуцированный режим кондиционирования по программе BEAM. В результате был достигнут клинический эффект в плане снижения уровня инвалидизации и активности заболевания, наряду с соответствующим изменением качества жизни (QoL) и симптоматики. В период после трансплантации больной не проходил иммуносупрессивного или иммуномодулирующего лечения. Наши результаты показывают, что ВДХТ с ауто-ТГСК может рассматриваться в качестве эффективного способа лечения больных РС с высокой активностью заболевания и относительно низкой степенью инвалидизации. Снижение дозной интенсивности при лечении, по-видимому, не влияет на исход терапии. Оценки показателей качества жизни и симптоматики представляются эффективным подходом к оценке исходов лечения больных РС.
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A.A. Novik1, A.N. Kuznetsov1, V.Y. Melnichenko1, D.A. Fedorenko1, T.I. Ionova1, R.V. Kruglina1, A.V. Kartashov1, K.A. Kurbatova1,
G.I. Gorodokin2
1Pirogov National Medical Surgical Center, the Department of Hematology and Cellular Therapy and the Department of Neurology, Pirogov National Medical Surgical Center, Moscow, Russia;
2New Jersey Center for Quality of Life and Health Outcome Research, USA
During the last several years high dose chemotherapy (HDCT) with autologous stem cell transplantation (auto-HSCT) has been established as a therapeutic option for multiple sclerosis (MS) patients. We report clinical and patient-reported outcomes of HDCT + auto-HSCT in a male patient affected by secondary progressive MS (EDSS 5.0 at base-line). Reduced BEAM conditioning regimen was used. As a result, clinical response in terms of reduction of disability and disease activity was achieved along with quality of life (QoL) treatment response and symptom treatment response. The patient was off immunosuppressive or immunomodulating therapy throughout the post-transplant period. Our findings demonstrate that HDCT+auto-HSCT might be considered as an effective treatment for MS patients with high disease activity and relatively low disability rate. Reduction of dose intensity seems to have no influence on treatment outcome. QoL and symptom measurement appears to be an effective approach to assessment of treatment outcomes in patients with MS.
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[TEXT] => <H3>Цель исследования</h3>
<p>Определить частоту ИМ у пациентов после алло-ТГСК, выявить факторы риска, способствующие развитию ИМ.</p>
<h3>Материалы и методы</h3>
<p>С 2000г. по июнь 2008г. выполнена 221 алло-ТГСК от неродственного, родственного, частично совместимого (гаплоидентичного) донора. Из них до 21года – 131 пациентам, старше 21 года – 90 пациентам, медиана возраста составила 21 год (1-66 лет). У 87 пациентов (39,4%) алло-ТГСК произведена в рецидиве заболевания.<h3>Результаты</h3>
<p>Частота ИМ при алло-ТГСК составила 28%, 35% и 38% соответвенно при использовании родственного, неродственного и гаплоидентичного доноров, а также 32% у пациентов до 21 года и 27% в группе пациентов старше 21 года. ИМ диагностирован соответственно у 32% и 17% пациентов с МРК (миелоаблативный кондиционирующий режим кондиционирования), у 34% и 31% с не МРК до 21 года и старше (p>0,05). В обеих группах источник ГСК, скорость восстановления кроветворения донора не имели самостоятельного воздействия при оценке вероятности возникновения ИМ у пациентов после алло-ТГСК. <br /><br />Значение возраста и источника ГСК усиливалось при многофакторном анализе параметров, влиющих на развитие ИМ после алло-ТГСК. Проведение алло-ТГСК от родственного донора с неМРК в рецидиве заболевания увеличивало риск развития ИМ в 1,8 раза у пациентов старше 21 (p<0,05). Напротив, при алло-ТГСК в ремиссии ИМ развивался реже, особенно при использовании ПСКК (p<0,05).
</p>
<p class="bodytext">Влияние трансплантата отмечено и в возрасте до 21 года, где вероятность развития ИМ была выше при проведении алло-ТГСК в рецидиве заболевания с МРК и КМ в качестве источника трансплнтата (p>0,05).
</p>
<p class="bodytext">Установлено, что стадия заболевания, мукозит I-IV степени (p<0,05) и распространенная форма хронической РТПХ (p<0,05) являются наиболее значимыми отрицательными факторами. Их наличие создаёт условия для развития ИМ вне зависимости от режима кондиционирования и источника трансплантата. <br /> <br />В возрасте старше 21 года назначение АЛГ в режиме кондиционирования увеличивало вероятность развития ИМ (p<0,05). Общая 5-летняя выживаемость пациентов всех возрастных групп вне зависимости от стадии заболевания составила 40% и 18% при отсутствии и наличии ИМ, соответственно. </p>
<h3>Заключение</h3>
<p>Таким образом, наличие ИМ влияет на 5-летнюю ОВ пациентов. Основными факторами риска, влияющими на частоту ИМ после алло-ТГСК в возрастных группах до и старше 21 года являются стадия заболевания, развитие мукозита и распространенной формы хрРТПХ.
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Определить частоту ИМ у пациентов после алло-ТГСК, выявить факторы риска, способствующие развитию ИМ.
Материалы и методы
С 2000г. по июнь 2008г. выполнена 221 алло-ТГСК от неродственного, родственного, частично совместимого (гаплоидентичного) донора. Из них до 21года – 131 пациентам, старше 21 года – 90 пациентам, медиана возраста составила 21 год (1-66 лет). У 87 пациентов (39,4%) алло-ТГСК произведена в рецидиве заболевания.
Результаты
Частота ИМ при алло-ТГСК составила 28%, 35% и 38% соответвенно при использовании родственного, неродственного и гаплоидентичного доноров, а также 32% у пациентов до 21 года и 27% в группе пациентов старше 21 года. ИМ диагностирован соответственно у 32% и 17% пациентов с МРК (миелоаблативный кондиционирующий режим кондиционирования), у 34% и 31% с не МРК до 21 года и старше (p>0,05). В обеих группах источник ГСК, скорость восстановления кроветворения донора не имели самостоятельного воздействия при оценке вероятности возникновения ИМ у пациентов после алло-ТГСК.
Значение возраста и источника ГСК усиливалось при многофакторном анализе параметров, влиющих на развитие ИМ после алло-ТГСК. Проведение алло-ТГСК от родственного донора с неМРК в рецидиве заболевания увеличивало риск развития ИМ в 1,8 раза у пациентов старше 21 (p<0,05). Напротив, при алло-ТГСК в ремиссии ИМ развивался реже, особенно при использовании ПСКК (p<0,05).
Влияние трансплантата отмечено и в возрасте до 21 года, где вероятность развития ИМ была выше при проведении алло-ТГСК в рецидиве заболевания с МРК и КМ в качестве источника трансплнтата (p>0,05).
Установлено, что стадия заболевания, мукозит I-IV степени (p<0,05) и распространенная форма хронической РТПХ (p<0,05) являются наиболее значимыми отрицательными факторами. Их наличие создаёт условия для развития ИМ вне зависимости от режима кондиционирования и источника трансплантата.
В возрасте старше 21 года назначение АЛГ в режиме кондиционирования увеличивало вероятность развития ИМ (p<0,05). Общая 5-летняя выживаемость пациентов всех возрастных групп вне зависимости от стадии заболевания составила 40% и 18% при отсутствии и наличии ИМ, соответственно.
Заключение
Таким образом, наличие ИМ влияет на 5-летнюю ОВ пациентов. Основными факторами риска, влияющими на частоту ИМ после алло-ТГСК в возрастных группах до и старше 21 года являются стадия заболевания, развитие мукозита и распространенной формы хрРТПХ.
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N. I. Zubarovskaya, E. V. Semenova, N. V. Stancheva, V. N. Vavilov, I. V. Kazantsev, Yu. G. Vasilieva, N. N. Klimko, B. V. Afanasyev
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N. I. Zubarovskaya, E. V. Semenova, N. V. Stancheva, V. N. Vavilov, I. V. Kazantsev, Yu. G. Vasilieva, N. N. Klimko, B. V. Afanasyev
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[TEXT] => <p>R. M. Gorbacheva Memorial Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, <br>St. Petersburg, Russia</p>
<br>
<p class="bodytext"><b>Correspondence:</b> Natalia Zubarovskaya, Memorial R.M. Gorbacheva Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, 6/8, Tolstoy str., St. Petersburg, 199044, Russia, Tel.: +7 (812) 499-68-19, Fax: +7 (812) 234-06-16,<br> E-mail: <a href="javascript:linkTo_UnCryptMailto('qempxs.dsyfevszDqemp2vy');">zoubarov@<span style="display:none;">spam is bad</span>mail.ru</a> <sup><br /></sup>
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St. Petersburg, Russia
Correspondence: Natalia Zubarovskaya, Memorial R.M. Gorbacheva Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, 6/8, Tolstoy str., St. Petersburg, 199044, Russia, Tel.: +7 (812) 499-68-19, Fax: +7 (812) 234-06-16,
E-mail: zoubarov@mail.ru
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[TEXT] => <h3>Background</h3>
<p> The aim of the study was to determine the risk factors and incidence of invasive fungal diseases (IFD) in patients after allo-HSCT.</p>
<h3>Materials and patients</h3>
<p>In our department 221 allo-HSCTs from related, unrelated and haploidentical donors were performed between October 2000 and June 2008. In the study were enrolled 131 patients younger than 21 and 90 patients older than 21 years old after allo-HSCT. In 87 (37%) patients allo-HSCT was conducted in non-remission.</p>
<h3>Results</h3>
<p>The incidence of IFD after allo-HSCT remains high. Depending on donor characteristics (HLA-matched related, unrelated or haploidentical donor) it is 28%, 35%, and 38% respectively. Looking at age it is 32% for patients ≤21 years, and 27% for patients >21 years. In the RIC regimen group IFD was diagnosed in 34% of younger (≤21 years) patients and 31% of older (>21 years); and for the MC group it amounted to 32% for younger (p>0.05) and 17% for elder age groups (p<0.05). Neither the rate of IFD in both age groups, the source of HSC and/or rate of post-transplant engraftment were found to independently exert influence on the incidence of IFD following allo-SCT. <br /><br />In multifactor analysis was noticed correlation between HSC sources and age.<br /><br />IFD incidence was 1.8-fold higher in elder relapsed patients after related allo-HSCT with RIC (p<0.05). Contrariwise, in this group the incidence of IFD was low in patients that underwent HSCT in remission and received PBSC (p<0.05). The influence of transplant type was also noticed in the younger (≤21 years) group: the probability of IFD development was much higher in relapsed patients after BM allo-HSCT with RIC (p<0.05). It was noticed that the disease stage, grade I–IV mucositis (p<0.05), and extensive cGVHD (p<0.05) were the most prominent risk factors for IFD development. When these factors are present no difference was seen in groups with different conditioning regimens and HSC sources. <br /><br />In patients >21 years IFD incidence increased by inclusion of ATG in the conditioning regimen (p<0.05). </p>
<h3>Conclusions</h3>
<p>The main risk factors that influence the incidence of IFD after allo-HSCT in all age groups are the stage of the disease, mucositis development, and extensive form of cGVHD. After diagnosis of IFD 12-weeks OS is 50%. IFD impairs 5-years OS after allo-HSCT.</p>
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[TEXT] => Background
The aim of the study was to determine the risk factors and incidence of invasive fungal diseases (IFD) in patients after allo-HSCT.
Materials and patients
In our department 221 allo-HSCTs from related, unrelated and haploidentical donors were performed between October 2000 and June 2008. In the study were enrolled 131 patients younger than 21 and 90 patients older than 21 years old after allo-HSCT. In 87 (37%) patients allo-HSCT was conducted in non-remission.
Results
The incidence of IFD after allo-HSCT remains high. Depending on donor characteristics (HLA-matched related, unrelated or haploidentical donor) it is 28%, 35%, and 38% respectively. Looking at age it is 32% for patients ≤21 years, and 27% for patients >21 years. In the RIC regimen group IFD was diagnosed in 34% of younger (≤21 years) patients and 31% of older (>21 years); and for the MC group it amounted to 32% for younger (p>0.05) and 17% for elder age groups (p<0.05). Neither the rate of IFD in both age groups, the source of HSC and/or rate of post-transplant engraftment were found to independently exert influence on the incidence of IFD following allo-SCT.
In multifactor analysis was noticed correlation between HSC sources and age.
IFD incidence was 1.8-fold higher in elder relapsed patients after related allo-HSCT with RIC (p<0.05). Contrariwise, in this group the incidence of IFD was low in patients that underwent HSCT in remission and received PBSC (p<0.05). The influence of transplant type was also noticed in the younger (≤21 years) group: the probability of IFD development was much higher in relapsed patients after BM allo-HSCT with RIC (p<0.05). It was noticed that the disease stage, grade I–IV mucositis (p<0.05), and extensive cGVHD (p<0.05) were the most prominent risk factors for IFD development. When these factors are present no difference was seen in groups with different conditioning regimens and HSC sources.
In patients >21 years IFD incidence increased by inclusion of ATG in the conditioning regimen (p<0.05).
Conclusions
The main risk factors that influence the incidence of IFD after allo-HSCT in all age groups are the stage of the disease, mucositis development, and extensive form of cGVHD. After diagnosis of IFD 12-weeks OS is 50%. IFD impairs 5-years OS after allo-HSCT.
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N. I. Zubarovskaya, E. V. Semenova, N. V. Stancheva, V. N. Vavilov, I. V. Kazantsev, Yu. G. Vasilieva, N. N. Klimko, B. V. Afanasyev
R. M. Gorbacheva Memorial Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University,
St. Petersburg, Russia
Correspondence: Natalia Zubarovskaya, Memorial R.M. Gorbacheva Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, 6/8, Tolstoy str., St. Petersburg, 199044, Russia, Tel.: +7 (812) 499-68-19, Fax: +7 (812) 234-06-16,
E-mail: zoubarov@mail.ru
Background
The aim of the study was to determine the risk factors and incidence of invasive fungal diseases (IFD) in patients after allo-HSCT.
Materials and patients
In our department 221 allo-HSCTs from related, unrelated and haploidentical donors were performed between October 2000 and June 2008. In the study were enrolled 131 patients younger than 21 and 90 patients older than 21 years old after allo-HSCT. In 87 (37%) patients allo-HSCT was conducted in non-remission.
Results
The incidence of IFD after allo-HSCT remains high. Depending on donor characteristics (HLA-matched related, unrelated or haploidentical donor) it is 28%, 35%, and 38% respectively. Looking at age it is 32% for patients ≤21 years, and 27% for patients >21 years. In the RIC regimen group IFD was diagnosed in 34% of younger (≤21 years) patients and 31% of older (>21 years); and for the MC group it amounted to 32% for younger (p>0.05) and 17% for elder age groups (p<0.05). Neither the rate of IFD in both age groups, the source of HSC and/or rate of post-transplant engraftment were found to independently exert influence on the incidence of IFD following allo-SCT.
In multifactor analysis was noticed correlation between HSC sources and age.
IFD incidence was 1.8-fold higher in elder relapsed patients after related allo-HSCT with RIC (p<0.05). Contrariwise, in this group the incidence of IFD was low in patients that underwent HSCT in remission and received PBSC (p<0.05). The influence of transplant type was also noticed in the younger (≤21 years) group: the probability of IFD development was much higher in relapsed patients after BM allo-HSCT with RIC (p<0.05). It was noticed that the disease stage, grade I–IV mucositis (p<0.05), and extensive cGVHD (p<0.05) were the most prominent risk factors for IFD development. When these factors are present no difference was seen in groups with different conditioning regimens and HSC sources.
In patients >21 years IFD incidence increased by inclusion of ATG in the conditioning regimen (p<0.05).
Conclusions
The main risk factors that influence the incidence of IFD after allo-HSCT in all age groups are the stage of the disease, mucositis development, and extensive form of cGVHD. After diagnosis of IFD 12-weeks OS is 50%. IFD impairs 5-years OS after allo-HSCT.
Research articles
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[TEXT] => <p>Посттрансфузионная перегрузка железом (ПЖ) является относительно частым осложнением, возникающем при длительном лечении различных гематологических заболеваний. У реципиентов гемопоэтических стволовых клеток (ГСК), как аллогенных, так и аутологичных, часто отмечается ПЖ из-за проведения трансфузий эритроцитов в период первичного лечения и в посттрансплантационном периоде. Кроме того, есть и некоторые состояния, которые приводят к повышенному риску ПЖ. </p>
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<p>Предлагается скрининг всех кандидатов на трансплантацию ГСК и всех больных после трансплантации на наличие ПЖ до трансплантации и в различные сроки после нее. Ферритин сыворотки неспецифичен для ПЖ и является плохим прогностическим маркером нагрузки организма железом. Он может быть использован для оценки ПЖ, но его рекомендуется применять вместе с рядом других параметров.</p>
<p>Адекватная терапия хелатами может ослабить нагрузку железом и ее осложнения и должна назначаться по мере появления признаков ПЖ. Необходимы дальнейшие исследования для уточнения естественной истории ПЖ и ее вклада в позднюю заболеваемость и смертность у реципиентов после трансплантации. </p>
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Целый ряд ранних посттрансплантационных осложнений, включая инфекции, нарушения функций печени и синдром обструкции синусоидов печени, связаны с ПЖ. Позднее развитие этого заболевания исходно связано с поражением сердца и печени. Сообщалось о том, что ПЖ повышает риск инфекций в поздние сроки после трансплантации.
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Адекватная терапия хелатами может ослабить нагрузку железом и ее осложнения и должна назначаться по мере появления признаков ПЖ. Необходимы дальнейшие исследования для уточнения естественной истории ПЖ и ее вклада в позднюю заболеваемость и смертность у реципиентов после трансплантации.
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[TEXT] => <p>Posttransfusional iron overload is a relatively common complication related to long-term treatment of various haematological diseases. Haematopoietic stem cell transplant recipients - both allogenic and autologous - often present with iron overload because of exposure to red blood cell (RBC) transfusions during the initial treatment and in the post transplant period. Despite these there are also some conditions which contribute to increased risk for iron overload.</p>
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M. Ivanova, E. Morozova, Y. Vasilieva, Y. Rudnitskaya, R. Nabiev, L. Zubarovskaya, B. Afanasyev
Memorial R. M. Gorbacheva Institute of Children Hematology and Transplantation, St. Petersburg Pavlov State Medical University, St. Petersburg, Russia
Posttransfusional iron overload is a relatively common complication related to long-term treatment of various haematological diseases. Haematopoietic stem cell transplant recipients - both allogenic and autologous - often present with iron overload because of exposure to red blood cell (RBC) transfusions during the initial treatment and in the post transplant period. Despite these there are also some conditions which contribute to increased risk for iron overload.
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It has been suggested that all candidates for and all survivors of haematopoietic stem cell transplantation HSCT should be screened for iron overload at various time points before and after transplantation. Serum ferritin is sensitive but not specific for iron overload and is a poor predictor of body iron burden. It can be used for iron overload assessment, but it is recommended to use it together with some other parameters.
Adequate chelation therapy can reduce iron burden and complications and should be administered as soon as there are signs of iron overload.
More studies are needed to better define the natural history of iron overload and its impact on late morbidity and mortality in transplant recipients.
Research articles
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[TEXT] => Целью мобилизации ГСК является получение не менее 2×106 CD34+ клеток на килограмм массы тела реципиента, что принято считать нижним уровнем, позволяющим достичь быстрого и устойчивого приживления трансплантата. Опыт использования Г-КСФ в качестве мобилизующего агента позволил разработать стандартные схемы стимуляции. Тем не менее, у определенной части пациентов при планировании аутологичной трансплантации в ходе стандартной процедуры мобилизации не удается получить достаточного количества ГСК. Плохой ответ или отсутствие ответа на мобилизацию требует проведения последующей ремобилизации и/или дополнительных процедур афереза, что негативно сказывается на состоянии пациента, а также приводит к увеличению экономических затрат.
Значительное число пациентов, плохо отвечающих на мобилизацию, делает необходимым анализ факторов, влияющих на эффективность данного процесса. В исследовании проведен анализ клинико-лабораторных данных с целью выявления факторов, оказывающих влияние на результат мобилизации.
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[TEXT] => <p class="bodytext">Mobilized peripheral blood stem cells (PBSC) have become the main source for autologous and allogeneic hemopoietic stem cells transplantation (HSCT) following myeloablative therapy in patients with hematological malignancies or solid tumors. Classical strategies for PBSC mobilization include administration of granulocyte colony-stimulating factor (G-CSF) alone or in combination with other agents or myelosuppressive chemotherapy. PBSC mobilization and collection have been optimized in numerous clinical trials, but a proportion of patients fail to mobilize. The aim of the study was to establish the influence of diagnosis, sex, age, number of previous courses of chemotherapy, mobilization regimen, and bone marrow (BM) involvement on the outcome of peripheral blood stem cell mobilization. </p>
<h3>Patients and methods</h3>
<p>121 patients with hematological malignancies and solid tumors were included in the study (Hodgkin’s lymphoma (HD) (n=24), non-Hodgkin lymphomas (NHL) (n=29), multiple myeloma (MM) (n=32), acute leukemias (AL) (n=15), and solid tumors (ST) (n=21)). 100 patients (82%) were mobilized with G-CSF, and a combination of chemotherapy and G-CSF was used in 21 patients (18%). 57 patients (49%) received more than six courses of chemotherapy and 74 (51%) less than six respectively. The criterion for adequate mobilization was a score of at least 2.0 x 10<sup>6</sup> CD34+ cells/kg of body weight. </p>
<h3Results</h3>
<p>In our trial there was no correlation between PBSC yield and the patient’s diagnosis, age, or gender. BM involvement does not seem to be an independent factor, with significant adverse influence on PBSC mobilization (p=0.78). Stem cell yield was significantly higher in those patients who received fewer than six courses of chemotherapy (10.0 ± 2.2 х 10<sup>6</sup> CD<sup>34+</sup>/kg against 5.5 ± 1.7 х 10<sup>6</sup> CD<sup>34+</sup>/kg (p=0.006)). A better outcome was seen in patients mobilized with chemotherapy plus G-CSF than with G-CSF alone (8.12 ± 1.12 х 10<sup>6</sup> CD<sup>34+</sup>/kg against 6.9 ± 0.9 х 10<sup>6</sup> CD<sup>34+</sup>/kg (p= 0.008)).</p><h3>Conclusions</h3>
<p>Diagnosis, age, sex, and bone marrow involvement does not influence the outcome of stem cell mobilization. Better stem cell yield was seen in patients who received fewer than six courses of chemotherapy, and in patients mobilized with cytokines combined with chemotherapy than cytokines alone.</p>
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[TEXT] => Mobilized peripheral blood stem cells (PBSC) have become the main source for autologous and allogeneic hemopoietic stem cells transplantation (HSCT) following myeloablative therapy in patients with hematological malignancies or solid tumors. Classical strategies for PBSC mobilization include administration of granulocyte colony-stimulating factor (G-CSF) alone or in combination with other agents or myelosuppressive chemotherapy. PBSC mobilization and collection have been optimized in numerous clinical trials, but a proportion of patients fail to mobilize. The aim of the study was to establish the influence of diagnosis, sex, age, number of previous courses of chemotherapy, mobilization regimen, and bone marrow (BM) involvement on the outcome of peripheral blood stem cell mobilization.
Patients and methods
121 patients with hematological malignancies and solid tumors were included in the study (Hodgkin’s lymphoma (HD) (n=24), non-Hodgkin lymphomas (NHL) (n=29), multiple myeloma (MM) (n=32), acute leukemias (AL) (n=15), and solid tumors (ST) (n=21)). 100 patients (82%) were mobilized with G-CSF, and a combination of chemotherapy and G-CSF was used in 21 patients (18%). 57 patients (49%) received more than six courses of chemotherapy and 74 (51%) less than six respectively. The criterion for adequate mobilization was a score of at least 2.0 x 106 CD34+ cells/kg of body weight.
In our trial there was no correlation between PBSC yield and the patient’s diagnosis, age, or gender. BM involvement does not seem to be an independent factor, with significant adverse influence on PBSC mobilization (p=0.78). Stem cell yield was significantly higher in those patients who received fewer than six courses of chemotherapy (10.0 ± 2.2 х 106 CD34+/kg against 5.5 ± 1.7 х 106 CD34+/kg (p=0.006)). A better outcome was seen in patients mobilized with chemotherapy plus G-CSF than with G-CSF alone (8.12 ± 1.12 х 106 CD34+/kg against 6.9 ± 0.9 х 106 CD34+/kg (p= 0.008)).
Conclusions
Diagnosis, age, sex, and bone marrow involvement does not influence the outcome of stem cell mobilization. Better stem cell yield was seen in patients who received fewer than six courses of chemotherapy, and in patients mobilized with cytokines combined with chemotherapy than cytokines alone.
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Alexeev S., Babenko E., Estrina M., Mikhailova N., Zubarovskaya L., Afanasyev B.
St. Petersburg Pavlov State Medical University, St. Petersburg, Russia
Mobilized peripheral blood stem cells (PBSC) have become the main source for autologous and allogeneic hemopoietic stem cells transplantation (HSCT) following myeloablative therapy in patients with hematological malignancies or solid tumors. Classical strategies for PBSC mobilization include administration of granulocyte colony-stimulating factor (G-CSF) alone or in combination with other agents or myelosuppressive chemotherapy. PBSC mobilization and collection have been optimized in numerous clinical trials, but a proportion of patients fail to mobilize. The aim of the study was to establish the influence of diagnosis, sex, age, number of previous courses of chemotherapy, mobilization regimen, and bone marrow (BM) involvement on the outcome of peripheral blood stem cell mobilization.
Patients and methods
121 patients with hematological malignancies and solid tumors were included in the study (Hodgkin’s lymphoma (HD) (n=24), non-Hodgkin lymphomas (NHL) (n=29), multiple myeloma (MM) (n=32), acute leukemias (AL) (n=15), and solid tumors (ST) (n=21)). 100 patients (82%) were mobilized with G-CSF, and a combination of chemotherapy and G-CSF was used in 21 patients (18%). 57 patients (49%) received more than six courses of chemotherapy and 74 (51%) less than six respectively. The criterion for adequate mobilization was a score of at least 2.0 x 106 CD34+ cells/kg of body weight.
In our trial there was no correlation between PBSC yield and the patient’s diagnosis, age, or gender. BM involvement does not seem to be an independent factor, with significant adverse influence on PBSC mobilization (p=0.78). Stem cell yield was significantly higher in those patients who received fewer than six courses of chemotherapy (10.0 ± 2.2 х 106 CD34+/kg against 5.5 ± 1.7 х 106 CD34+/kg (p=0.006)). A better outcome was seen in patients mobilized with chemotherapy plus G-CSF than with G-CSF alone (8.12 ± 1.12 х 106 CD34+/kg against 6.9 ± 0.9 х 106 CD34+/kg (p= 0.008)).
Conclusions
Diagnosis, age, sex, and bone marrow involvement does not influence the outcome of stem cell mobilization. Better stem cell yield was seen in patients who received fewer than six courses of chemotherapy, and in patients mobilized with cytokines combined with chemotherapy than cytokines alone.