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Introduction

Infection with human immunodefi ciency virus (HIV) is associated with a signifi cantly increased risk of cancer, including Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) even when patients are treated successfully with contemporary antiretroviral therapy [1, 2]. AIDS related malignancies remain a leading cause of mortality [3]. Before the introduction of highly active anti-retroviral therapy (HAART), HIV-infected patients were not candidates for standard, combination chemotherapeutic regimens because of the signifi cant risk of opportunistic infection and poor malignancy response rates [4]. Th erapy outcome in patients with HIV-related malignancies have improved since the improvement of HAART availability [5-8]. In the HAART era, treatment of HIV-related lymphomas with standard doses of chemotherapy became possible for HIV positive patients [9-14].
The role of autologous hematopoietic stem cell transplantation (ASCT) in the care of patients with HIV-related lymphoma, however, remains unclear. In the non-HIV setting, patients with relapsed refractory NHL and HL have benefits from treatment with high-dose chemotherapy and ASCT [15, 16]. Early pivotal studies come from Europe and the United States demonstrated safety and effi cacy the use of ASCT in the care of patients with high-risk, relapsed refractory HIV-related lymphoma [17, 18]. Th ese initial experiences were encouraging and spurred other investigators to study the use of ASCT for patients with lymphoma and HIV. Th e summary of the studies of high-dose chemotherapy followed by autologous hematopoietic cell transplantation in HIV-related lymphoma adapted from the Serrano et al. [19] is outlined in Table 1. Th e limitation of these studies is their retrospective nature with a large variety in patient population, status of the disease, conditioning regimen and HAART strategy. Th at is why the role of high-dose chemotherapy followed by ASCT in lymphoma patients with HIV is still a subject of controversy.
There is an urgent need for prospective comparative matched case-controlled studies to prove the safety and efficacy of ASCT in HIV-related lymphoma and their number is limited. There are three studies have been published that in one way or another meet the criteria prospective, comparative, matched case-controlled studies [26, 27, 28]. Here we report the early results of a single institution, EBMT center CIC725, matched case-control study. Th is was an observational trial designed to prospectively evaluate the safety and effectiveness of ASCT for patients with HIV-related lymphoma.

Patients and methods

Study design

Between January 2016 and October 2017, an observational study was conducted at Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation, The First State I. Pavlov Medical University of St. Petersburg (CIC725). Seven patients with HIV-related NHL or HL were enrolled in a trial. An approval for the trial was issued by the University Institutional Review Board. All the patients signed an approved informed consent, in accordance with the Declaration of Helsinki. The data on twenty-eight non-HIV-infected lymphoma patients who underwent ASCT at the same time period (control group, n=28) were also collected to compare the effi cacy and safety of the procedure (1:4). The patients were matched for age at ASCT, disease status at ASCT, number of prior regimens of chemotherapy, time from lymphoma diagnosis to ASCT, conditioning regimen and tumor histology.

Eligibility criteria

The indications for ASCT included NHL or HL if they met standard transplant criteria. HIV positive patients were required to exhibit a viral load of <50,000 copies/ml, being free of overt opportunistic infections at the time of ASCT, and receiving HAART for more than 6 months.

Stem cell mobilization and conditioning regimen

For stem cell mobilization, the patients received cyclophosphamide (CY) at 4000 mg/m2 with hydration, and Mesna (15 mg/kg) before and 3, 6, and 9 hours aft er CY for uroprotection, or an alternative salvage chemotherapy to which the lymphoma was responding. Granulocyte colonystimulating factor (G-CSF) was administered at a dose of 10 μg/kg/day starting 2 days aft er the chemotherapy. Leukapheresis was performed since the white blood count (WBC) reached ≥0.5×109/L, a maximum of 3 harvests, until an intended number of 2×106 CD34+ cells/kg has been collected. In cases of poor stem cell mobilization (failed leukapheresis), bone marrow (BM) served as a source of hematopoietic stem cells (HSC) using a standard surgical procedure. Patients who met trial eligibility criteria underwent ASCT following a preparative regimen that consisted of modifi ed BEAM to BeEAM treatment where the carmustine 300 mg/m2 (day -6) was replaced by Bendamustine 160 mg/ m2/day at day -7, day -6. Etoposide 100 mg/m2 daily (days -5 to -2), cytarabine200 mg/m2 twice daily (days -5 to -2), and melphalan 140 mg/m2 (day -1) [29]. Patients underwent ASCT on day 0 and received growth factor, transfusion, and antimicrobial supportive care as per the respective institutional standards.
Autologous peripheral stem cells were thawed in a 37°C water bath and infused through the patient’s central venous catheter on transplantation day 0.

Clinical endpoints

This study was designed to assess the safety and tolerability of intensive chemotherapy and ASCT for the treatment of HIV-related NHL and HL. Th e primary end point for the trial was one-year OS aft er ASCT. The secondary endpoints were as follows: hematopoietic recovery and organ toxicity, transplant-related mortality (TRM), progression free survival (PFS), the cumulative incidence of relapse/progressionat 12 months aft er ASCT.
The patients underwent daily routine post-transplant blood tests from day 0 through the period of neutrophil recovery, and as per the respective institutional standards. The time to hematopoietic recovery was defi ned as the fi rst of day of >500 neutrophils/μL following nadir and time to platelet count >20,000/μL at the fi rst of day with no platelet transfusions for 2 preceding days. Post-AHCT toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4. Microbiologically documented infections were classifi ed by clinical site, date of onset, and severity of the disease. Th e disease status was assessed in the patients before ASCT, at day +100 or earlier if signs of the disease re-appeared, and 1 year aft er ASCT. Responses of lymphoma to therapy were assessed using the Cheson criteria for determination of complete remission (CR), and CR+ partial remission (PR) rates at day +100 [30]. Th e data of tests for HIV status (CD4+ cells, viral load) were collected from the HIV Department where the patients were assigned and observed.

Statistical analysis

Survival estimates were calculated based on the Kaplan-Meier method. Differences between survival curves were assessed by the log-rank test. Potential baseline diff erences between the two groups were examined using the Mann-Whitney test for continuous variables or Fisher’s exact test for categorical variables. Patients who were alive at the time of analysis were censored at the last contact date. Overall survival was defi ned as the interval from day 0 ASCT to the death from any cause. Transplant-related mortality was defi ned as death occurring in a patient from causes other than relapse/progression. Progression free survival was defined as the  interval from day 0 ASCT to death, disease relapse, or progression.
The cumulative incidence of relapse/progressionwas defined as relapse or progressionoccurring in a patient the interval from day 0 ASCT to 12 months.

Results

Patient characteristics

A consecutive case-series of 7 HIV-group patients and 28 matched control group treated with ASCT between January 2016 and October 2017 were included. Patient, disease, and treatment characteristics for both groups are provided in Table 2. Both groups were comparable for all clinical and transplantation characteristics except for the higher proportion of male sex (p=0.03) in HIV-group, misbalance in type of lymphoma: presence of non-Hodgkin T-cell lymphoma and prevalence of Hodgkin lymphoma in control group.

One patient was diagnosed with HIV infection concomitant with the lymphoma diagnosis and started on antiretroviral therapy together with chemo. Meanwhile, six patients in HIV group had a long history of HIV infection before the lymphoma was diagnosed. Median time from the registration of HIV-positive status to lymphoma diagnosis was 1734 days (57.8 months). HIV status in study group at the moment of transplantation was as follows: HIV viral load was undetectable (100%); the median number of CD4+ cells was 265 cells/mcl; all the subjects received HAART. Neither patient had any planned or needed interruptions in their HAART during ASCT. All individual patient and HAART regimen have been consulted with the HIV specialist and changed the regimen before ASCT taking into account drug-drug interactions. Only in two patients before ASCT the modifi cation of the scheme HAART was required.
Six patients in HIV group received peripheral blood stem cell graft s, and BM was transfused in one case. The median transplanted HSC dose was 3.9×106 CD34+ cells/kg (range, 1.6-11.0). A median of 2 apheresis collections was performed (range, 1-3). A median of 3.4×106 CD34+ cells/kg (range, 2.6-6.0×106/kg) was transfused to the patients.

Engraftment

The median time to achievement of an absolute neutrophil count (ANC) of ≥0.5×109/L was similar for both groups: 14 days (range, 11-30 days) in HIV-infected group and 16 days (range, 10-30 days) in control group (Fig. 1a). The median time to achievement of an unsupported platelet count of ≥20×109/L was 15 days (range, 11-30 days) in HIV-infected group and 14 days (range, 11-30 days) in control group (Fig. 1b).

Toxicities

No fatal regimen-related toxicity occurred. Neither patient developed grade III or IV nausea or vomiting. Three patients developed oropharyngeal mucositis (3 cases – grade I-II, no one grade III). Tree patients experienced febrile neutropenia. Three patients had a documented bacteremia within 100 days post-ASCT (1 coagulase-negative staphylococcus, 2 Klebsiella pneumoniae). Comparative characteristics of non-hematologic toxicities (≤100 days post-ASCT) are listed
in Table 3.

Outcomes

With a median follow-up of 12 months (range, 1.2-20.7 months) in HIV group and 8 (1-20) months in control group, 2 patients died in control group; one of them died within 1 year of transplant. Relapse of the underlying disease was a cause of death in both cases. There were no registered events classifi ed as transplant-related mortality. Th e overall one-year survival (n=35) was 97.1%. Overall survival at 1 year was 100% in HIV group, 96.4% – control group, and were not significantly diff erent between the groups (Fig. 2a). At the time of transplant, 4 (57%) patients in HIV group and 17 (60.7%) patients in control group were in CR, three patients (42.8%) in HIV group and 8 (28.5%) patients in control group were in PR, whereas three (10.7%) patient in control group had active diseaseat the moment of ASCT after achieving a PR to salvage therapy. During the first year aft er ASCT, 1 (3.6%) patient in control group had relapse of the disease and died on day +73 and 1 patient (14.2%) in HIV group with HL where the anticancer immunotherapy was initiated. Th e probability of 1-year PFS for all patients was 88.6%, in HIV group – 85.7% and 89.3% for control group (p=0.98) (Fig. 2b). Th e cumulative incidence of relapse/progression at 1 year was 11.4%. Th e cumulative incidence of relapse/ progression was 14,3% in HIV group and did not differ from the control group 10.7% (p=0.98).

Discussion

Wide application of effective anti-HIV therapy allowed patients with HIV-related lymphoma to benefi t from standard chemotherapeutic regimens [9-14]. Clinical outcomes after treatment of these patients, including OS and PFS of treatment these patients similar comparable with those of non–HIV-infected individuals both in NHL and HL cases [7, 11, 13, 14, 31].
In the early 90’s clinical studies established ASCT as the standard of care for managing patients with chemotherapy-sensitive, relapsed/refractory NHL and HL [15-16, 32]. HIV infection historically has been considered as a contraindication to ASCT. With the improvement of supportive care, and the accumulation of experience in ASCT, as well as long-term results of the use of HAART there was an opportunity to extend implementation of high-dose chemotherapy followed by ASCT to HIV-infected patients. Series of the studies has been reported ASCT as a feasible, safe, and useful approach to either rescue or consolidate HIV-related lymphoma patients [19, 20-26].
Alvarnas JC et al. highlighted that published ASCT studies were largely limited to centers with signifi cant HIV-related expertise. Th is has prevented full acceptance of ASCT as the standard of care for patients with relapsed and resistant HIV-related lymphoma [26]. We cannot disagree with the statement of Dr. Alvarnas. Our transplant activity confirms the fact that ASCT for patients with lymphoma and HIV remain largely limited to centers with signifi cant HIV-specifi c expertise [33].
Today we need prospective comparative matched case-controlled studies in order to confi rm safety and effi cacy of ASCT in HIV-related lymphoma. Th ree studies that in one way or another meet these criteria were published. One study is a single-institution one, from the City of Hope – the United States center that pioneered the use of hematopoietic stem cell transplantation for HIV positive patients [27]. Two other comparative trials represent a registry-based studies from the EBMT and CIBMTR databases [26, 28]. Table 4 presents a summary of trials with appropriate comparative analyses of HIV-infected patients and matched cohorts from non–HIV-infected patients who underwent ASCT for treatment of NHL and HL. Th e well-designed single center and multicenter studies have shown that HIV status does not affect the outcome of ASCT performed for NHL and HL. Such a conclusion is based on a total group of 122 HIV-infected individuals with lymphoma observed in the three studies.
This study and early-stage data confi rm some previously published statements that high-dose chemotherapy with ASCT is a safe and eff ective procedure in patients with highrisk, relapsed refractory HIV-related lymphoma. The issues of ASCT safety in this category of patients become actual given that HSCT is a platform for development and application of gene therapy, both with classic and more advanced genome editing techniques aimed to eradicate HIV infection [34-37]. In the last few years with a development of the genome editing technology based on autologous hematopoietic stem cell transplantation is becoming one of the most promising methods of HIV one shot therapy procedure. Hematopoietic stem cells are one of the most popular and promising target for gene therapy protocols for the treatment of numerous disease and conditions, due to their tissue-specific homing, ability for diff erentiation and production of various blood cells, as well as broad clinical experience with their transplantation [38, 39].

There is no doubt that further research in this field and every new patient treated with ASCT procedure is of great value, and multicenter prospective comparative matched case-controlled studies are required. Our pilot study involved a modest number of patients observed for limited terms. However, it contributes to the solution of an urgent problem. Our preliminary data provide further evidence that HIV status does not aff ect the outcome of ASCT for lymphoma. Patients with HIV-related lymphoma should be considered candidates for ASCT if they meet standard transplant criteria.

Acknowledgments

The authors would like to acknowledge all medical staff at our University’ BMT clinic CIC725. Special thanks to our transplant nurses for their particular care of our patients. Many thanks to the HIV specialists at the First Pavlov State Medical University of Saint-Petersburg, especially to Prof. Lioznov D. A., Chief of the Department, and to entire medical staff of St. Petersburg HIV Center for detailed clinical and laboratory data provided for the patients.

Conflict of interest

No conflict of interests is declared.

References

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" ["~DETAIL_TEXT"]=> string(30896) "

Introduction

Infection with human immunodefi ciency virus (HIV) is associated with a signifi cantly increased risk of cancer, including Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) even when patients are treated successfully with contemporary antiretroviral therapy [1, 2]. AIDS related malignancies remain a leading cause of mortality [3]. Before the introduction of highly active anti-retroviral therapy (HAART), HIV-infected patients were not candidates for standard, combination chemotherapeutic regimens because of the signifi cant risk of opportunistic infection and poor malignancy response rates [4]. Th erapy outcome in patients with HIV-related malignancies have improved since the improvement of HAART availability [5-8]. In the HAART era, treatment of HIV-related lymphomas with standard doses of chemotherapy became possible for HIV positive patients [9-14].
The role of autologous hematopoietic stem cell transplantation (ASCT) in the care of patients with HIV-related lymphoma, however, remains unclear. In the non-HIV setting, patients with relapsed refractory NHL and HL have benefits from treatment with high-dose chemotherapy and ASCT [15, 16]. Early pivotal studies come from Europe and the United States demonstrated safety and effi cacy the use of ASCT in the care of patients with high-risk, relapsed refractory HIV-related lymphoma [17, 18]. Th ese initial experiences were encouraging and spurred other investigators to study the use of ASCT for patients with lymphoma and HIV. Th e summary of the studies of high-dose chemotherapy followed by autologous hematopoietic cell transplantation in HIV-related lymphoma adapted from the Serrano et al. [19] is outlined in Table 1. Th e limitation of these studies is their retrospective nature with a large variety in patient population, status of the disease, conditioning regimen and HAART strategy. Th at is why the role of high-dose chemotherapy followed by ASCT in lymphoma patients with HIV is still a subject of controversy.
There is an urgent need for prospective comparative matched case-controlled studies to prove the safety and efficacy of ASCT in HIV-related lymphoma and their number is limited. There are three studies have been published that in one way or another meet the criteria prospective, comparative, matched case-controlled studies [26, 27, 28]. Here we report the early results of a single institution, EBMT center CIC725, matched case-control study. Th is was an observational trial designed to prospectively evaluate the safety and effectiveness of ASCT for patients with HIV-related lymphoma.

Patients and methods

Study design

Between January 2016 and October 2017, an observational study was conducted at Raisa Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation, The First State I. Pavlov Medical University of St. Petersburg (CIC725). Seven patients with HIV-related NHL or HL were enrolled in a trial. An approval for the trial was issued by the University Institutional Review Board. All the patients signed an approved informed consent, in accordance with the Declaration of Helsinki. The data on twenty-eight non-HIV-infected lymphoma patients who underwent ASCT at the same time period (control group, n=28) were also collected to compare the effi cacy and safety of the procedure (1:4). The patients were matched for age at ASCT, disease status at ASCT, number of prior regimens of chemotherapy, time from lymphoma diagnosis to ASCT, conditioning regimen and tumor histology.

Eligibility criteria

The indications for ASCT included NHL or HL if they met standard transplant criteria. HIV positive patients were required to exhibit a viral load of <50,000 copies/ml, being free of overt opportunistic infections at the time of ASCT, and receiving HAART for more than 6 months.

Stem cell mobilization and conditioning regimen

For stem cell mobilization, the patients received cyclophosphamide (CY) at 4000 mg/m2 with hydration, and Mesna (15 mg/kg) before and 3, 6, and 9 hours aft er CY for uroprotection, or an alternative salvage chemotherapy to which the lymphoma was responding. Granulocyte colonystimulating factor (G-CSF) was administered at a dose of 10 μg/kg/day starting 2 days aft er the chemotherapy. Leukapheresis was performed since the white blood count (WBC) reached ≥0.5×109/L, a maximum of 3 harvests, until an intended number of 2×106 CD34+ cells/kg has been collected. In cases of poor stem cell mobilization (failed leukapheresis), bone marrow (BM) served as a source of hematopoietic stem cells (HSC) using a standard surgical procedure. Patients who met trial eligibility criteria underwent ASCT following a preparative regimen that consisted of modifi ed BEAM to BeEAM treatment where the carmustine 300 mg/m2 (day -6) was replaced by Bendamustine 160 mg/ m2/day at day -7, day -6. Etoposide 100 mg/m2 daily (days -5 to -2), cytarabine200 mg/m2 twice daily (days -5 to -2), and melphalan 140 mg/m2 (day -1) [29]. Patients underwent ASCT on day 0 and received growth factor, transfusion, and antimicrobial supportive care as per the respective institutional standards.
Autologous peripheral stem cells were thawed in a 37°C water bath and infused through the patient’s central venous catheter on transplantation day 0.

Clinical endpoints

This study was designed to assess the safety and tolerability of intensive chemotherapy and ASCT for the treatment of HIV-related NHL and HL. Th e primary end point for the trial was one-year OS aft er ASCT. The secondary endpoints were as follows: hematopoietic recovery and organ toxicity, transplant-related mortality (TRM), progression free survival (PFS), the cumulative incidence of relapse/progressionat 12 months aft er ASCT.
The patients underwent daily routine post-transplant blood tests from day 0 through the period of neutrophil recovery, and as per the respective institutional standards. The time to hematopoietic recovery was defi ned as the fi rst of day of >500 neutrophils/μL following nadir and time to platelet count >20,000/μL at the fi rst of day with no platelet transfusions for 2 preceding days. Post-AHCT toxicities were graded using the Common Terminology Criteria for Adverse Events, version 4. Microbiologically documented infections were classifi ed by clinical site, date of onset, and severity of the disease. Th e disease status was assessed in the patients before ASCT, at day +100 or earlier if signs of the disease re-appeared, and 1 year aft er ASCT. Responses of lymphoma to therapy were assessed using the Cheson criteria for determination of complete remission (CR), and CR+ partial remission (PR) rates at day +100 [30]. Th e data of tests for HIV status (CD4+ cells, viral load) were collected from the HIV Department where the patients were assigned and observed.

Statistical analysis

Survival estimates were calculated based on the Kaplan-Meier method. Differences between survival curves were assessed by the log-rank test. Potential baseline diff erences between the two groups were examined using the Mann-Whitney test for continuous variables or Fisher’s exact test for categorical variables. Patients who were alive at the time of analysis were censored at the last contact date. Overall survival was defi ned as the interval from day 0 ASCT to the death from any cause. Transplant-related mortality was defi ned as death occurring in a patient from causes other than relapse/progression. Progression free survival was defined as the  interval from day 0 ASCT to death, disease relapse, or progression.
The cumulative incidence of relapse/progressionwas defined as relapse or progressionoccurring in a patient the interval from day 0 ASCT to 12 months.

Results

Patient characteristics

A consecutive case-series of 7 HIV-group patients and 28 matched control group treated with ASCT between January 2016 and October 2017 were included. Patient, disease, and treatment characteristics for both groups are provided in Table 2. Both groups were comparable for all clinical and transplantation characteristics except for the higher proportion of male sex (p=0.03) in HIV-group, misbalance in type of lymphoma: presence of non-Hodgkin T-cell lymphoma and prevalence of Hodgkin lymphoma in control group.

One patient was diagnosed with HIV infection concomitant with the lymphoma diagnosis and started on antiretroviral therapy together with chemo. Meanwhile, six patients in HIV group had a long history of HIV infection before the lymphoma was diagnosed. Median time from the registration of HIV-positive status to lymphoma diagnosis was 1734 days (57.8 months). HIV status in study group at the moment of transplantation was as follows: HIV viral load was undetectable (100%); the median number of CD4+ cells was 265 cells/mcl; all the subjects received HAART. Neither patient had any planned or needed interruptions in their HAART during ASCT. All individual patient and HAART regimen have been consulted with the HIV specialist and changed the regimen before ASCT taking into account drug-drug interactions. Only in two patients before ASCT the modifi cation of the scheme HAART was required.
Six patients in HIV group received peripheral blood stem cell graft s, and BM was transfused in one case. The median transplanted HSC dose was 3.9×106 CD34+ cells/kg (range, 1.6-11.0). A median of 2 apheresis collections was performed (range, 1-3). A median of 3.4×106 CD34+ cells/kg (range, 2.6-6.0×106/kg) was transfused to the patients.

Engraftment

The median time to achievement of an absolute neutrophil count (ANC) of ≥0.5×109/L was similar for both groups: 14 days (range, 11-30 days) in HIV-infected group and 16 days (range, 10-30 days) in control group (Fig. 1a). The median time to achievement of an unsupported platelet count of ≥20×109/L was 15 days (range, 11-30 days) in HIV-infected group and 14 days (range, 11-30 days) in control group (Fig. 1b).

Toxicities

No fatal regimen-related toxicity occurred. Neither patient developed grade III or IV nausea or vomiting. Three patients developed oropharyngeal mucositis (3 cases – grade I-II, no one grade III). Tree patients experienced febrile neutropenia. Three patients had a documented bacteremia within 100 days post-ASCT (1 coagulase-negative staphylococcus, 2 Klebsiella pneumoniae). Comparative characteristics of non-hematologic toxicities (≤100 days post-ASCT) are listed
in Table 3.

Outcomes

With a median follow-up of 12 months (range, 1.2-20.7 months) in HIV group and 8 (1-20) months in control group, 2 patients died in control group; one of them died within 1 year of transplant. Relapse of the underlying disease was a cause of death in both cases. There were no registered events classifi ed as transplant-related mortality. Th e overall one-year survival (n=35) was 97.1%. Overall survival at 1 year was 100% in HIV group, 96.4% – control group, and were not significantly diff erent between the groups (Fig. 2a). At the time of transplant, 4 (57%) patients in HIV group and 17 (60.7%) patients in control group were in CR, three patients (42.8%) in HIV group and 8 (28.5%) patients in control group were in PR, whereas three (10.7%) patient in control group had active diseaseat the moment of ASCT after achieving a PR to salvage therapy. During the first year aft er ASCT, 1 (3.6%) patient in control group had relapse of the disease and died on day +73 and 1 patient (14.2%) in HIV group with HL where the anticancer immunotherapy was initiated. Th e probability of 1-year PFS for all patients was 88.6%, in HIV group – 85.7% and 89.3% for control group (p=0.98) (Fig. 2b). Th e cumulative incidence of relapse/progression at 1 year was 11.4%. Th e cumulative incidence of relapse/ progression was 14,3% in HIV group and did not differ from the control group 10.7% (p=0.98).

Discussion

Wide application of effective anti-HIV therapy allowed patients with HIV-related lymphoma to benefi t from standard chemotherapeutic regimens [9-14]. Clinical outcomes after treatment of these patients, including OS and PFS of treatment these patients similar comparable with those of non–HIV-infected individuals both in NHL and HL cases [7, 11, 13, 14, 31].
In the early 90’s clinical studies established ASCT as the standard of care for managing patients with chemotherapy-sensitive, relapsed/refractory NHL and HL [15-16, 32]. HIV infection historically has been considered as a contraindication to ASCT. With the improvement of supportive care, and the accumulation of experience in ASCT, as well as long-term results of the use of HAART there was an opportunity to extend implementation of high-dose chemotherapy followed by ASCT to HIV-infected patients. Series of the studies has been reported ASCT as a feasible, safe, and useful approach to either rescue or consolidate HIV-related lymphoma patients [19, 20-26].
Alvarnas JC et al. highlighted that published ASCT studies were largely limited to centers with signifi cant HIV-related expertise. Th is has prevented full acceptance of ASCT as the standard of care for patients with relapsed and resistant HIV-related lymphoma [26]. We cannot disagree with the statement of Dr. Alvarnas. Our transplant activity confirms the fact that ASCT for patients with lymphoma and HIV remain largely limited to centers with signifi cant HIV-specifi c expertise [33].
Today we need prospective comparative matched case-controlled studies in order to confi rm safety and effi cacy of ASCT in HIV-related lymphoma. Th ree studies that in one way or another meet these criteria were published. One study is a single-institution one, from the City of Hope – the United States center that pioneered the use of hematopoietic stem cell transplantation for HIV positive patients [27]. Two other comparative trials represent a registry-based studies from the EBMT and CIBMTR databases [26, 28]. Table 4 presents a summary of trials with appropriate comparative analyses of HIV-infected patients and matched cohorts from non–HIV-infected patients who underwent ASCT for treatment of NHL and HL. Th e well-designed single center and multicenter studies have shown that HIV status does not affect the outcome of ASCT performed for NHL and HL. Such a conclusion is based on a total group of 122 HIV-infected individuals with lymphoma observed in the three studies.
This study and early-stage data confi rm some previously published statements that high-dose chemotherapy with ASCT is a safe and eff ective procedure in patients with highrisk, relapsed refractory HIV-related lymphoma. The issues of ASCT safety in this category of patients become actual given that HSCT is a platform for development and application of gene therapy, both with classic and more advanced genome editing techniques aimed to eradicate HIV infection [34-37]. In the last few years with a development of the genome editing technology based on autologous hematopoietic stem cell transplantation is becoming one of the most promising methods of HIV one shot therapy procedure. Hematopoietic stem cells are one of the most popular and promising target for gene therapy protocols for the treatment of numerous disease and conditions, due to their tissue-specific homing, ability for diff erentiation and production of various blood cells, as well as broad clinical experience with their transplantation [38, 39].

There is no doubt that further research in this field and every new patient treated with ASCT procedure is of great value, and multicenter prospective comparative matched case-controlled studies are required. Our pilot study involved a modest number of patients observed for limited terms. However, it contributes to the solution of an urgent problem. Our preliminary data provide further evidence that HIV status does not aff ect the outcome of ASCT for lymphoma. Patients with HIV-related lymphoma should be considered candidates for ASCT if they meet standard transplant criteria.

Acknowledgments

The authors would like to acknowledge all medical staff at our University’ BMT clinic CIC725. Special thanks to our transplant nurses for their particular care of our patients. Many thanks to the HIV specialists at the First Pavlov State Medical University of Saint-Petersburg, especially to Prof. Lioznov D. A., Chief of the Department, and to entire medical staff of St. Petersburg HIV Center for detailed clinical and laboratory data provided for the patients.

Conflict of interest

No conflict of interests is declared.

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При внедрении высокоактивной антиретровирусной терапии (ВААРТ) продемонстрировано, что аутологичная трансплантация стволовых клеток (ауто-ТГСК) является приемлемым, безопасный и эффективным методом лечения пациентов с лимфомами на фоне ВИЧ. Однако количество сравнительных исследований влияния статуса ВИЧ на результаты ауто-ТГСК ограничено. Мы представляем исследование, целью которого является оценить безопасность и эффективность высокодозной химиотерапии с ауто-ТГСК у пациентов с лимфомами на фоне ВИЧ. С января 2016 года выполнены ауто-ТГСК семи пациентам с ВИЧ-ассоциированными лимфомами. Для проведения сравнительного анализа, в исследование включены 28 пациентов с лимфомами без ВИЧ инфекции, которым выполнена ауто-ТГСК в тот же период времени (группа контроля, в соотношении 1:4). Проводилась сравнительная оценка общей 1-годичной выживаемости, восстановления кроветворения, токсичности, выживаемости без прогрессирования и кумулятивной частоты рецидивов/прогрессирования в течение одного года после ауто-ТГСК. Общая выживаемость в течение одного года после ауто-ТГСК у пациентов с ВИЧ-ассоциированными лимфомами составила 100%, выживаемость без прогрессирования – 85,7%, частота рецидивов – 14,3% и не отличалась от группы сравнения. При анализе токсичности и скорости восстановления кроветворения значимых различий в группах сравнения не обнаружено. Предварительные данные подтверждают, что ВИЧ статус не влияет на результаты ауто-ТГСК для лечения лимфом, и поэтому наличие ВИЧ-инфекции само по себе, не должно влиять на принятие решения о проведении высокодозной химиотерапии с аутологичной трансплантацией гемопоэтических стволовых клеток. </p> <h2 style="text-align: justify;">Ключевые слова</h2> <p style="text-align: justify;"> Аутологичная трансплантация гемопоэтических стволовых клеток, ВИЧ, ВИЧ-ассоциированные лимфомы, высокодозная химиотерапия, неходжкинские лимфомы, лимфома Ходжкина, сравнительное исследование «случай-контроль». </p>" ["ELEMENT_PREVIEW_PICTURE_FILE_TITLE"]=> string(350) "Аутологичная трансплантация гемопоэтических ство- ловых клеток у пациентов с ВИЧ-ассоциированными лимфомами: результаты одноцентрового (CIC725) сравнительного исследования «случай-контроль»" ["ELEMENT_DETAIL_PICTURE_FILE_ALT"]=> string(350) "Аутологичная трансплантация гемопоэтических ство- ловых клеток у пациентов с ВИЧ-ассоциированными лимфомами: результаты одноцентрового (CIC725) сравнительного исследования «случай-контроль»" ["ELEMENT_DETAIL_PICTURE_FILE_TITLE"]=> string(350) "Аутологичная трансплантация гемопоэтических ство- ловых клеток у пациентов с ВИЧ-ассоциированными лимфомами: результаты одноцентрового (CIC725) сравнительного исследования «случай-контроль»" ["SECTION_META_TITLE"]=> string(350) "Аутологичная трансплантация гемопоэтических ство- ловых клеток у пациентов с ВИЧ-ассоциированными лимфомами: результаты одноцентрового (CIC725) сравнительного исследования «случай-контроль»" ["SECTION_META_KEYWORDS"]=> string(350) "Аутологичная трансплантация гемопоэтических ство- ловых клеток у пациентов с ВИЧ-ассоциированными лимфомами: результаты одноцентрового (CIC725) сравнительного исследования «случай-контроль»" ["SECTION_META_DESCRIPTION"]=> string(350) "Аутологичная трансплантация гемопоэтических ство- ловых клеток у пациентов с ВИЧ-ассоциированными лимфомами: результаты одноцентрового (CIC725) сравнительного исследования «случай-контроль»" ["SECTION_PICTURE_FILE_ALT"]=> string(350) "Аутологичная трансплантация гемопоэтических ство- ловых клеток у пациентов с ВИЧ-ассоциированными лимфомами: результаты одноцентрового (CIC725) сравнительного исследования «случай-контроль»" ["SECTION_PICTURE_FILE_TITLE"]=> string(350) "Аутологичная трансплантация гемопоэтических ство- ловых клеток у пациентов с ВИЧ-ассоциированными лимфомами: результаты одноцентрового (CIC725) сравнительного исследования «случай-контроль»" ["SECTION_PICTURE_FILE_NAME"]=> string(100) "autologichnaya-transplantatsiya-gemopoeticheskikh-stvo-lovykh-kletok-u-patsientov-s-vich-assotsiirov" ["SECTION_DETAIL_PICTURE_FILE_ALT"]=> string(350) "Аутологичная трансплантация гемопоэтических ство- ловых клеток у пациентов с ВИЧ-ассоциированными лимфомами: результаты одноцентрового (CIC725) сравнительного исследования «случай-контроль»" ["SECTION_DETAIL_PICTURE_FILE_TITLE"]=> string(350) "Аутологичная трансплантация гемопоэтических ство- 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Попова, Юлия A. Рогачева, Анастасия В. Некрасова, Иван В. Циганков, Али Базахел, Кирилл В. Лепик, Ольга В. Пирогова, Елена И. Дарская, Лилия В. Стельмах, Юрий Р. Залялов, Иван С. Моисеев, Сергей Н. Бондаренко, Наталья Б. Михайлова, Борис В. Афанасьев<br>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(456) "Марина O. Попова, Юлия A. Рогачева, Анастасия В. Некрасова, Иван В. Циганков, Али Базахел, Кирилл В. Лепик, Ольга В. Пирогова, Елена И. Дарская, Лилия В. Стельмах, Юрий Р. Залялов, Иван С. Моисеев, Сергей Н. Бондаренко, Наталья Б. Михайлова, Борис В. Афанасьев
" ["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"]=> string(5) "20011" ["VALUE"]=> array(2) { ["TEXT"]=> string(429) "НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Кафедра гематологии, трансфузиологии и трансплантологии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова (CIC725)<br>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(423) "НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой, Кафедра гематологии, трансфузиологии и трансплантологии, Первый Санкт-Петербургский государственный медицинский университет им. акад. И. П. Павлова (CIC725)
" ["TYPE"]=> string(4) "HTML" } ["~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) "20012" ["VALUE"]=> array(2) { ["TEXT"]=> string(3939) "<p style="text-align: justify;"> Пациенты, инфицированные вирусом иммунодефицита человека (ВИЧ) находятся в группе повышенного риска развития неходжскинских лимфом и лимфомы Ходжкина. При внедрении высокоактивной антиретровирусной терапии (ВААРТ) продемонстрировано, что аутологичная трансплантация стволовых клеток (ауто-ТГСК) является приемлемым, безопасный и эффективным методом лечения пациентов с лимфомами на фоне ВИЧ. Однако количество сравнительных исследований влияния статуса ВИЧ на результаты ауто-ТГСК ограничено. Мы представляем исследование, целью которого является оценить безопасность и эффективность высокодозной химиотерапии с ауто-ТГСК у пациентов с лимфомами на фоне ВИЧ. С января 2016 года выполнены ауто-ТГСК семи пациентам с ВИЧ-ассоциированными лимфомами. Для проведения сравнительного анализа, в исследование включены 28 пациентов с лимфомами без ВИЧ инфекции, которым выполнена ауто-ТГСК в тот же период времени (группа контроля, в соотношении 1:4). Проводилась сравнительная оценка общей 1-годичной выживаемости, восстановления кроветворения, токсичности, выживаемости без прогрессирования и кумулятивной частоты рецидивов/прогрессирования в течение одного года после ауто-ТГСК. Общая выживаемость в течение одного года после ауто-ТГСК у пациентов с ВИЧ-ассоциированными лимфомами составила 100%, выживаемость без прогрессирования – 85,7%, частота рецидивов – 14,3% и не отличалась от группы сравнения. При анализе токсичности и скорости восстановления кроветворения значимых различий в группах сравнения не обнаружено. Предварительные данные подтверждают, что ВИЧ статус не влияет на результаты ауто-ТГСК для лечения лимфом, и поэтому наличие ВИЧ-инфекции само по себе, не должно влиять на принятие решения о проведении высокодозной химиотерапии с аутологичной трансплантацией гемопоэтических стволовых клеток. </p> <h2 style="text-align: justify;">Ключевые слова</h2> <p style="text-align: justify;"> Аутологичная трансплантация гемопоэтических стволовых клеток, ВИЧ, ВИЧ-ассоциированные лимфомы, высокодозная химиотерапия, неходжкинские лимфомы, лимфома Ходжкина, сравнительное исследование «случай-контроль». </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(3873) "

Пациенты, инфицированные вирусом иммунодефицита человека (ВИЧ) находятся в группе повышенного риска развития неходжскинских лимфом и лимфомы Ходжкина. При внедрении высокоактивной антиретровирусной терапии (ВААРТ) продемонстрировано, что аутологичная трансплантация стволовых клеток (ауто-ТГСК) является приемлемым, безопасный и эффективным методом лечения пациентов с лимфомами на фоне ВИЧ. Однако количество сравнительных исследований влияния статуса ВИЧ на результаты ауто-ТГСК ограничено. Мы представляем исследование, целью которого является оценить безопасность и эффективность высокодозной химиотерапии с ауто-ТГСК у пациентов с лимфомами на фоне ВИЧ. С января 2016 года выполнены ауто-ТГСК семи пациентам с ВИЧ-ассоциированными лимфомами. Для проведения сравнительного анализа, в исследование включены 28 пациентов с лимфомами без ВИЧ инфекции, которым выполнена ауто-ТГСК в тот же период времени (группа контроля, в соотношении 1:4). Проводилась сравнительная оценка общей 1-годичной выживаемости, восстановления кроветворения, токсичности, выживаемости без прогрессирования и кумулятивной частоты рецидивов/прогрессирования в течение одного года после ауто-ТГСК. Общая выживаемость в течение одного года после ауто-ТГСК у пациентов с ВИЧ-ассоциированными лимфомами составила 100%, выживаемость без прогрессирования – 85,7%, частота рецидивов – 14,3% и не отличалась от группы сравнения. При анализе токсичности и скорости восстановления кроветворения значимых различий в группах сравнения не обнаружено. Предварительные данные подтверждают, что ВИЧ статус не влияет на результаты ауто-ТГСК для лечения лимфом, и поэтому наличие ВИЧ-инфекции само по себе, не должно влиять на принятие решения о проведении высокодозной химиотерапии с аутологичной трансплантацией гемопоэтических стволовых клеток.

Ключевые слова

Аутологичная трансплантация гемопоэтических стволовых клеток, ВИЧ, ВИЧ-ассоциированные лимфомы, высокодозная химиотерапия, неходжкинские лимфомы, лимфома Ходжкина, сравнительное исследование «случай-контроль».

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Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation, Chair of Hematology, Transfusiology and Transplantation, Th e St. Petersburg First State Medical I. Pavlov University (CIC725)" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(222) "R. Gorbacheva Memorial Research Institute of Children Oncology, Hematology and Transplantation, Chair of Hematology, Transfusiology and Transplantation, Th e St. Petersburg First State Medical I. Pavlov University (CIC725)" ["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) "20016" ["VALUE"]=> array(2) { ["TEXT"]=> string(2428) "<p style="text-align: justify;"> Human immunodefi ciency virus (HIV) infection is associated with an increased incidence of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Throughout the HAART era, autologous stem cell transplantation (ASCT) has been reported as a feasible, safe, and useful approach to either rescue or consolidate HIV-related lymphoma patients. However, the number of published comparative studies according to the HIV status is limited. Th e aim of the study was to estimate the early safety and effi cacy of high-dose chemotherapy followed by autologous hematopoietic cell transplantation in HIV-related lymphoma. Since the Jan 2016 seven patients with HIV-related lymphoma who have undergone ASCT were included in the prospective singe centre study (study group – HIV group, n=7). T e data of the non-HIV-infected patients with lymphoma who have undergone ASCT at the same period of time (control group, n=28) were collected to compare the efficacy and safety of the procedure (ratio 1:4). Median follow up time was 12 (1-20) months in study group and 8 (1-20) months in control group. The primary endpoint was overall survival (OS) at 12 months after ASCT. Secondary end points were hematopoietic recovery and organ toxicity, progression free survival (PFS) and relapse rate at 12 months aft er ASCT. Here we report the early results of a single institution (EBMT center CIC725) matched case-control study. Th is was an observation trial designed to prospectively evaluate the safety and eff ectiveness of ASCT for patients with HIV-related lymphoma. One-year overall survival in patients with HIV-related lymphoma was 100%, the probability of PFS – 85,7%, relapse rate – 14,3% and did not diff er from the control group. There were not found statistical signifi cant diff erences between two groups in hematopoietic recovery and toxicity rate. Preliminary data provide further evidence that HIV status does not affect the outcome of ASCT for lymphoma, and therefore HIV status alone should no longer exclude these patients from transplant clinical trials. </p> <h2 style="text-align: justify;">Keywords</h2> <p style="text-align: justify;"> Autologous hematopoietic cell transplantation, HIV, HIV-related lymphoma, high-dose chemotherapy, non-Hodgkin lymphoma, Hodgkin lymphoma, matched case-control study. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2362) "

Human immunodefi ciency virus (HIV) infection is associated with an increased incidence of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Throughout the HAART era, autologous stem cell transplantation (ASCT) has been reported as a feasible, safe, and useful approach to either rescue or consolidate HIV-related lymphoma patients. However, the number of published comparative studies according to the HIV status is limited. Th e aim of the study was to estimate the early safety and effi cacy of high-dose chemotherapy followed by autologous hematopoietic cell transplantation in HIV-related lymphoma. Since the Jan 2016 seven patients with HIV-related lymphoma who have undergone ASCT were included in the prospective singe centre study (study group – HIV group, n=7). T e data of the non-HIV-infected patients with lymphoma who have undergone ASCT at the same period of time (control group, n=28) were collected to compare the efficacy and safety of the procedure (ratio 1:4). Median follow up time was 12 (1-20) months in study group and 8 (1-20) months in control group. The primary endpoint was overall survival (OS) at 12 months after ASCT. Secondary end points were hematopoietic recovery and organ toxicity, progression free survival (PFS) and relapse rate at 12 months aft er ASCT. Here we report the early results of a single institution (EBMT center CIC725) matched case-control study. Th is was an observation trial designed to prospectively evaluate the safety and eff ectiveness of ASCT for patients with HIV-related lymphoma. One-year overall survival in patients with HIV-related lymphoma was 100%, the probability of PFS – 85,7%, relapse rate – 14,3% and did not diff er from the control group. There were not found statistical signifi cant diff erences between two groups in hematopoietic recovery and toxicity rate. Preliminary data provide further evidence that HIV status does not affect the outcome of ASCT for lymphoma, and therefore HIV status alone should no longer exclude these patients from transplant clinical trials.

Keywords

Autologous hematopoietic cell transplantation, HIV, HIV-related lymphoma, high-dose chemotherapy, non-Hodgkin lymphoma, Hodgkin lymphoma, matched case-control study.

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Popova, Yulia A. Rogacheva, Anastasia V. Nekrasova, Ivan V. Tsygankov, Ali Basahel, Kirill V. Lepik, Olga V. Pirogova, Elena I. Darskaya, Lilia V. Stelmakh, Yurii R. Zalyalov, Ivan S. Moiseev, Sergey N. Bondarenko, Natalia B. Mikhailova, Boris V. Afanasyev<br>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(270) "Marina O. Popova, Yulia A. Rogacheva, Anastasia V. Nekrasova, Ivan V. Tsygankov, Ali Basahel, Kirill V. Lepik, Olga V. Pirogova, Elena I. Darskaya, Lilia V. Stelmakh, Yurii R. Zalyalov, Ivan S. Moiseev, Sergey N. Bondarenko, Natalia B. Mikhailova, Boris V. Afanasyev
" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(6) "Author" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(270) "Marina O. Popova, Yulia A. Rogacheva, Anastasia V. Nekrasova, Ivan V. Tsygankov, Ali Basahel, Kirill V. Lepik, Olga V. Pirogova, Elena I. Darskaya, Lilia V. Stelmakh, Yurii R. Zalyalov, Ivan S. Moiseev, Sergey N. Bondarenko, Natalia B. Mikhailova, Boris 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) "20016" ["VALUE"]=> array(2) { ["TEXT"]=> string(2428) "<p style="text-align: justify;"> Human immunodefi ciency virus (HIV) infection is associated with an increased incidence of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Throughout the HAART era, autologous stem cell transplantation (ASCT) has been reported as a feasible, safe, and useful approach to either rescue or consolidate HIV-related lymphoma patients. However, the number of published comparative studies according to the HIV status is limited. Th e aim of the study was to estimate the early safety and effi cacy of high-dose chemotherapy followed by autologous hematopoietic cell transplantation in HIV-related lymphoma. Since the Jan 2016 seven patients with HIV-related lymphoma who have undergone ASCT were included in the prospective singe centre study (study group – HIV group, n=7). T e data of the non-HIV-infected patients with lymphoma who have undergone ASCT at the same period of time (control group, n=28) were collected to compare the efficacy and safety of the procedure (ratio 1:4). Median follow up time was 12 (1-20) months in study group and 8 (1-20) months in control group. The primary endpoint was overall survival (OS) at 12 months after ASCT. Secondary end points were hematopoietic recovery and organ toxicity, progression free survival (PFS) and relapse rate at 12 months aft er ASCT. Here we report the early results of a single institution (EBMT center CIC725) matched case-control study. Th is was an observation trial designed to prospectively evaluate the safety and eff ectiveness of ASCT for patients with HIV-related lymphoma. One-year overall survival in patients with HIV-related lymphoma was 100%, the probability of PFS – 85,7%, relapse rate – 14,3% and did not diff er from the control group. There were not found statistical signifi cant diff erences between two groups in hematopoietic recovery and toxicity rate. Preliminary data provide further evidence that HIV status does not affect the outcome of ASCT for lymphoma, and therefore HIV status alone should no longer exclude these patients from transplant clinical trials. </p> <h2 style="text-align: justify;">Keywords</h2> <p style="text-align: justify;"> Autologous hematopoietic cell transplantation, HIV, HIV-related lymphoma, high-dose chemotherapy, non-Hodgkin lymphoma, Hodgkin lymphoma, matched case-control study. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2362) "

Human immunodefi ciency virus (HIV) infection is associated with an increased incidence of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Throughout the HAART era, autologous stem cell transplantation (ASCT) has been reported as a feasible, safe, and useful approach to either rescue or consolidate HIV-related lymphoma patients. However, the number of published comparative studies according to the HIV status is limited. Th e aim of the study was to estimate the early safety and effi cacy of high-dose chemotherapy followed by autologous hematopoietic cell transplantation in HIV-related lymphoma. Since the Jan 2016 seven patients with HIV-related lymphoma who have undergone ASCT were included in the prospective singe centre study (study group – HIV group, n=7). T e data of the non-HIV-infected patients with lymphoma who have undergone ASCT at the same period of time (control group, n=28) were collected to compare the efficacy and safety of the procedure (ratio 1:4). Median follow up time was 12 (1-20) months in study group and 8 (1-20) months in control group. The primary endpoint was overall survival (OS) at 12 months after ASCT. Secondary end points were hematopoietic recovery and organ toxicity, progression free survival (PFS) and relapse rate at 12 months aft er ASCT. Here we report the early results of a single institution (EBMT center CIC725) matched case-control study. Th is was an observation trial designed to prospectively evaluate the safety and eff ectiveness of ASCT for patients with HIV-related lymphoma. One-year overall survival in patients with HIV-related lymphoma was 100%, the probability of PFS – 85,7%, relapse rate – 14,3% and did not diff er from the control group. There were not found statistical signifi cant diff erences between two groups in hematopoietic recovery and toxicity rate. Preliminary data provide further evidence that HIV status does not affect the outcome of ASCT for lymphoma, and therefore HIV status alone should no longer exclude these patients from transplant clinical trials.

Keywords

Autologous hematopoietic cell transplantation, HIV, HIV-related lymphoma, high-dose chemotherapy, non-Hodgkin lymphoma, Hodgkin lymphoma, matched case-control study.

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Human immunodefi ciency virus (HIV) infection is associated with an increased incidence of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Throughout the HAART era, autologous stem cell transplantation (ASCT) has been reported as a feasible, safe, and useful approach to either rescue or consolidate HIV-related lymphoma patients. However, the number of published comparative studies according to the HIV status is limited. Th e aim of the study was to estimate the early safety and effi cacy of high-dose chemotherapy followed by autologous hematopoietic cell transplantation in HIV-related lymphoma. Since the Jan 2016 seven patients with HIV-related lymphoma who have undergone ASCT were included in the prospective singe centre study (study group – HIV group, n=7). T e data of the non-HIV-infected patients with lymphoma who have undergone ASCT at the same period of time (control group, n=28) were collected to compare the efficacy and safety of the procedure (ratio 1:4). Median follow up time was 12 (1-20) months in study group and 8 (1-20) months in control group. The primary endpoint was overall survival (OS) at 12 months after ASCT. Secondary end points were hematopoietic recovery and organ toxicity, progression free survival (PFS) and relapse rate at 12 months aft er ASCT. Here we report the early results of a single institution (EBMT center CIC725) matched case-control study. Th is was an observation trial designed to prospectively evaluate the safety and eff ectiveness of ASCT for patients with HIV-related lymphoma. One-year overall survival in patients with HIV-related lymphoma was 100%, the probability of PFS – 85,7%, relapse rate – 14,3% and did not diff er from the control group. There were not found statistical signifi cant diff erences between two groups in hematopoietic recovery and toxicity rate. Preliminary data provide further evidence that HIV status does not affect the outcome of ASCT for lymphoma, and therefore HIV status alone should no longer exclude these patients from transplant clinical trials.

Keywords

Autologous hematopoietic cell transplantation, HIV, HIV-related lymphoma, high-dose chemotherapy, non-Hodgkin lymphoma, Hodgkin lymphoma, matched case-control study.

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" } ["SUMMARY_RU"]=> array(37) { ["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) "20012" ["VALUE"]=> array(2) { ["TEXT"]=> string(3939) "<p style="text-align: justify;"> Пациенты, инфицированные вирусом иммунодефицита человека (ВИЧ) находятся в группе повышенного риска развития неходжскинских лимфом и лимфомы Ходжкина. При внедрении высокоактивной антиретровирусной терапии (ВААРТ) продемонстрировано, что аутологичная трансплантация стволовых клеток (ауто-ТГСК) является приемлемым, безопасный и эффективным методом лечения пациентов с лимфомами на фоне ВИЧ. Однако количество сравнительных исследований влияния статуса ВИЧ на результаты ауто-ТГСК ограничено. Мы представляем исследование, целью которого является оценить безопасность и эффективность высокодозной химиотерапии с ауто-ТГСК у пациентов с лимфомами на фоне ВИЧ. С января 2016 года выполнены ауто-ТГСК семи пациентам с ВИЧ-ассоциированными лимфомами. Для проведения сравнительного анализа, в исследование включены 28 пациентов с лимфомами без ВИЧ инфекции, которым выполнена ауто-ТГСК в тот же период времени (группа контроля, в соотношении 1:4). Проводилась сравнительная оценка общей 1-годичной выживаемости, восстановления кроветворения, токсичности, выживаемости без прогрессирования и кумулятивной частоты рецидивов/прогрессирования в течение одного года после ауто-ТГСК. Общая выживаемость в течение одного года после ауто-ТГСК у пациентов с ВИЧ-ассоциированными лимфомами составила 100%, выживаемость без прогрессирования – 85,7%, частота рецидивов – 14,3% и не отличалась от группы сравнения. При анализе токсичности и скорости восстановления кроветворения значимых различий в группах сравнения не обнаружено. Предварительные данные подтверждают, что ВИЧ статус не влияет на результаты ауто-ТГСК для лечения лимфом, и поэтому наличие ВИЧ-инфекции само по себе, не должно влиять на принятие решения о проведении высокодозной химиотерапии с аутологичной трансплантацией гемопоэтических стволовых клеток. </p> <h2 style="text-align: justify;">Ключевые слова</h2> <p style="text-align: justify;"> Аутологичная трансплантация гемопоэтических стволовых клеток, ВИЧ, ВИЧ-ассоциированные лимфомы, высокодозная химиотерапия, неходжкинские лимфомы, лимфома Ходжкина, сравнительное исследование «случай-контроль». </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(3873) "

Пациенты, инфицированные вирусом иммунодефицита человека (ВИЧ) находятся в группе повышенного риска развития неходжскинских лимфом и лимфомы Ходжкина. При внедрении высокоактивной антиретровирусной терапии (ВААРТ) продемонстрировано, что аутологичная трансплантация стволовых клеток (ауто-ТГСК) является приемлемым, безопасный и эффективным методом лечения пациентов с лимфомами на фоне ВИЧ. Однако количество сравнительных исследований влияния статуса ВИЧ на результаты ауто-ТГСК ограничено. Мы представляем исследование, целью которого является оценить безопасность и эффективность высокодозной химиотерапии с ауто-ТГСК у пациентов с лимфомами на фоне ВИЧ. С января 2016 года выполнены ауто-ТГСК семи пациентам с ВИЧ-ассоциированными лимфомами. Для проведения сравнительного анализа, в исследование включены 28 пациентов с лимфомами без ВИЧ инфекции, которым выполнена ауто-ТГСК в тот же период времени (группа контроля, в соотношении 1:4). Проводилась сравнительная оценка общей 1-годичной выживаемости, восстановления кроветворения, токсичности, выживаемости без прогрессирования и кумулятивной частоты рецидивов/прогрессирования в течение одного года после ауто-ТГСК. Общая выживаемость в течение одного года после ауто-ТГСК у пациентов с ВИЧ-ассоциированными лимфомами составила 100%, выживаемость без прогрессирования – 85,7%, частота рецидивов – 14,3% и не отличалась от группы сравнения. При анализе токсичности и скорости восстановления кроветворения значимых различий в группах сравнения не обнаружено. Предварительные данные подтверждают, что ВИЧ статус не влияет на результаты ауто-ТГСК для лечения лимфом, и поэтому наличие ВИЧ-инфекции само по себе, не должно влиять на принятие решения о проведении высокодозной химиотерапии с аутологичной трансплантацией гемопоэтических стволовых клеток.

Ключевые слова

Аутологичная трансплантация гемопоэтических стволовых клеток, ВИЧ, ВИЧ-ассоциированные лимфомы, высокодозная химиотерапия, неходжкинские лимфомы, лимфома Ходжкина, сравнительное исследование «случай-контроль».

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Пациенты, инфицированные вирусом иммунодефицита человека (ВИЧ) находятся в группе повышенного риска развития неходжскинских лимфом и лимфомы Ходжкина. При внедрении высокоактивной антиретровирусной терапии (ВААРТ) продемонстрировано, что аутологичная трансплантация стволовых клеток (ауто-ТГСК) является приемлемым, безопасный и эффективным методом лечения пациентов с лимфомами на фоне ВИЧ. Однако количество сравнительных исследований влияния статуса ВИЧ на результаты ауто-ТГСК ограничено. Мы представляем исследование, целью которого является оценить безопасность и эффективность высокодозной химиотерапии с ауто-ТГСК у пациентов с лимфомами на фоне ВИЧ. С января 2016 года выполнены ауто-ТГСК семи пациентам с ВИЧ-ассоциированными лимфомами. Для проведения сравнительного анализа, в исследование включены 28 пациентов с лимфомами без ВИЧ инфекции, которым выполнена ауто-ТГСК в тот же период времени (группа контроля, в соотношении 1:4). Проводилась сравнительная оценка общей 1-годичной выживаемости, восстановления кроветворения, токсичности, выживаемости без прогрессирования и кумулятивной частоты рецидивов/прогрессирования в течение одного года после ауто-ТГСК. Общая выживаемость в течение одного года после ауто-ТГСК у пациентов с ВИЧ-ассоциированными лимфомами составила 100%, выживаемость без прогрессирования – 85,7%, частота рецидивов – 14,3% и не отличалась от группы сравнения. При анализе токсичности и скорости восстановления кроветворения значимых различий в группах сравнения не обнаружено. Предварительные данные подтверждают, что ВИЧ статус не влияет на результаты ауто-ТГСК для лечения лимфом, и поэтому наличие ВИЧ-инфекции само по себе, не должно влиять на принятие решения о проведении высокодозной химиотерапии с аутологичной трансплантацией гемопоэтических стволовых клеток.

Ключевые слова

Аутологичная трансплантация гемопоэтических стволовых клеток, ВИЧ, ВИЧ-ассоциированные лимфомы, высокодозная химиотерапия, неходжкинские лимфомы, лимфома Ходжкина, сравнительное исследование «случай-контроль».

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Introduction

Graft-versus-host disease (GVHD) prophylaxis based on calcineurin inhibitors (CNI), namely cyclosporin A and tacrolimus, was developed in 1980s by Donald Th omas group [1] and is still the standard of care in the majority of European centers [2]. Although tacrolimus and cyclosporin A have some diff erences in the effi cacy aft er unrelated hematopoietic stem cell transplantation (HSCT), there are no signifi cant differences between these two agents for matched related graft s in the majority of studies [3,4]. Th is type of prophylaxis results in grade II-IV acute GVHD and chronic GVHD in about 20-40% of patients undergoing HSCT from matched related donors (MRD) [5-7].
A recent study by Luznik et al. demonstrated that post-transplant cyclophosphamide (PTCy) could be used as single-agent GVHD prophylaxis for matched bone marrow graft s with relatively low incidence of acute and chronic GVHD [8]. Th is fi nding was subsequently confi rmed in a multicenter study [9]. Th e single-agent PTCy regimen is associated with low immunosuppression burden and relatively fast immunologic recovery, so it is anticipated to reduce the rate of infectious complications and potentiate graft -versus-leukemia (GVL) eff ect [10, 11]. However, no studies were published with direct comparison of the prophylaxis with CNIs and PTCy as the single agent. Th is retrospective study compares patients transplanted for malignant diseases with these two types of GVHD prophylaxis.

Patients and methods

Patients and transplantation procedures

183 patients transplanted in 2006-2016 at the First St.Petersburg State I. Pavlov Medical University were enrolled in the study. Only first allogeneic transplantations were included. All patients received 10/10 HLA-matched bone marrow graft from related donor. Th e Ethical Committee of Pavlov First St. Petersburg State Medical University approved the usage of PTCy as a single-agent for GVHD prophylaxis. All patients signed informed consent for the use of their medical data to research purposes. 78 subjects received PTCy, and 105 were administered either cyclosporine A or tacrolimus combined with a second immunosuppressive agent. 49% of patients had acute myeloid leukemia; 31%, acute lymphoblastic leukemia (ALL); 8%, chronic myeloid leukemia; 3%, myelodysplastic syndrome, and 8%, malignant lymphomas. 27% of patients underwent salvage transplantation, defi ned as acute leukemia without hematologic remission, chronic myeloid leukemia in blast crisis and lymphomas in less than partial remission status. Comparative clinical characteristics of the two groups are presented in Table 1. PTCy group comprised less ALL patients, less salvage patients and a significantly later year of transplant. Th e other characteristics were comparable. Median follow-up in the control group was 50 months (range 8 to 111); in the PTCy group, 24 months (range 5 to 41).

Transplantation procedures

Myeloablative conditioning (MAC) was performed with oral busulfan at a dose of 16 mg/kg and cyclophosphamide (100-120 mg/kg). Reduced intensity conditioning (RIC) was performed with fl udarabine (180 mg/m2), and busulfan (8 mg/kg). Patients were assigned to RIC if they were 40 years or older, had HSCT-specifi c comorbidity index (HCTCI)≥ 2, grade >3 hepatic toxicity during induction therapy, or uncontrolled infection at the start of conditioning.
GVHD prophylaxis in the PTCy group consisted of single-agent cyclophosphamide (50 mg/kg) administered at days +3, +4. Mesna (50 mg/kg/day) was administered during the days of PTCy infusion. Glucocorticoid administration was prohibited from day -5 until day +5, except of cases with anaphylaxia and severe respiratory failure. In the groups with conventional prophylaxis, the patients received either tacrolimus with target concentrations of 5-15 ng/ml, or cyclosporine A, starting from the day -1, with target concentrations of 150-350 ng/ml. Th e second agent in the prophylaxis regimen was methotrexate administered as a short course (10-15 mg/m2) at days +1,+3,+6, or mycophenolate mofetil (MMF) 30 mg/kg from day -1 to day +30.
Supportive care included omeprasole 40 mg/day, acyclovir 600 mg/day, trimetoprim/sulfamethaxazole 960 mg/day, allopurinol and unfractionated heparin (100 IU/kg/day) starting day -7. In patients without previous history of invasive fungal infection, prophylaxis was done with fl uconazole (400 mg/day) starting on day 0, in patients with history or evidence of invasive aspergillosis, with voriconazole (400 mg/day) starting on day 0. Premedication before graft transfusion in the PTCy group was performed with metamesole 2 g and diphenhydramine 20 mg and steroids 1 mg/kg were added in the conventional prophylaxis group.

Clinical definitions

Time to disease relapse, acute GVHD (GVHD), moderate to severe chronic GVHD (cGVHD), non-relapse mortality (NRM), overall survival (OS), event-free survival (EFS), and GVHD-relapse free survival (GRFS) were defi ned as the time from transplantation to the event. All these parameters were calculated for the two-year interval. Incidence of aGVHD was calculated at 125 days aft er HSCT, and the time frame for the other outcomes was three years. Events for EFS were relapse or death. Events for GRFS were either death, relapse, grade III-IV acute GVHD or systemic therapy-requiring chronic GVHD. Th e Consensus Conference criteria and NIH criteria were used for aGVHD and cGVHD grading, respectively [12, 13]. Primary graft failure was defined as a complete absence of donor chimerism in bone marrow biopsy by day +40. Time to engraft ment was calculated as a time period from HSCT to unsupported neutrophil count of >500/μl and white blood cell count >1000/μl for 3  onsecutive days. Toxicity was assessed with CTCAE ver. 4.03. Sepsis in the study was defi ned as systemic infl ammatory reaction with microbiologically confi rmed bacteremia. Th e multivariate correction was performed with Hematopoietic Cell Transplantation-specifi c Comorbidity Index (HCT-CI) [14] and disease risk index (DRI) by Armand et al. [15].

Statistical Analysis

Comparison of groups was performed by Chi-square test. The survival distributions for OS, EFS, GRFS were calculated using Kaplan-Meier methodology. Th e comparisons were made using the log-rank test. Cumulative incidence analysis with competing risks for aGVHD, cGVHD, relapse incidence and NRM was performed using Gray test. Relapse and NRM were accounted as competing risks. Early discontinuation of immunosuppression due to relapse or minimal residual disease was considered a competing risk for aGVHD. Donor lymphocyte infusion was considered a competing risk for cGVHD. Multivariate analysis was done using proportional hazard regression. Fine and Grey regression was used for the multivariate analysis of cumulative incidences [16]. Factors used for multivariate correction had at least p=0.15 significance in the univariate analysis. Heterogeneities between the hazard ratios in the subgroup analysis were tested for significance using the Cochran’s Q test, with df degrees of freedom. Incidence and severity of complications was compared using Mann-Whitney test. Analyses were conducted in SAS 9.3 (SAS Institute, Inc.).

Results

Engraftment and graft-versus-host disease

Incidence of primary graft failure was not diff erent between groups (1.1 vs 1.6%, p=0.42). Nonetheless, engraft ment in the PTCy group was slower when assessed by neutrophil count (19 vs 24 days, p<0.001) and platelet count (17 vs 23 days, p=0.005). Acute GVHD grade II-IV was significantly less frequent in the PTCy group (8% vs 27%, p=0.0021, multivariate HR 0.239, 95% CI 0.099-0.58). The superiority of PTCy was also observed for grade III-IV acute GVHD (4% vs 15%, p=0.0040, multivariate HR 0.192, 95% CI 0.055-0.666) (Fig. 1). Incidence of grade I acute GVHD was not different (18% vs 13%, p=0.39) in the PTCy and conventional prophylaxis groups, respectively.
Moderate and severe chronic GVHD was not different between PTCy and CNIs groups (26% vs 30%, p=0.938, multivariate HR 0.898, 95% CI 0.477-1.69). Incidence of mild chronic GVHD was also not diff erent (9% vs 10%, p=0.60). Mortality, relapses and survival outcomes NRM was lower in the PTCy group in the univariate analysis (8% vs 22%, p=0.0195), although there was no diff erence when corrected for other variables (HR 0.384, 95% CI 0.089-1.437, p=0.1768). Relapse incidence was not diff erent in the univariate analysis (40% vs 49%, p=0.0896) in the PTCy and CNIs groups, respectively. However, in the multivariate analysis the use of PTCy was associated with lower incidence of relapse (HR 0.519, 95% CI 0.297-0.893, p=0.023). These NRM and relapse incidence borderline improvements translated in superior OS (62% vs 41%, p=0.0027, multivariate HR 0.489, 95% CI 0.261-0.917), EFS (52% vs 31%, p=0.0013, multivariate HR 0.571, 95% CI 0.334-0.976) and GVHD-relapse-free survival (30% vs 12%, p=0.0006, multivariate HR 0.493, 95% CI 0.309-0.786) (Fig. 1).

Unadjusted parameters represent results of univariate analysis; adjusted parameters represent results of multivariate analysis. In the multivariate analyses, co-variables  or acute GVHD were as follows: intensity of the conditioning; age and female donor for male recipient. Co-variable for chronic moderate and severe (m&s) GVHD was only previous acute GVHD; co-variables for NRM were intensity of the conditioning, salvage status, HCT-CI, occurrence of severe sepsis, female donor for male recipient, development of transplant-associated microangiopathy and year of transplant; co-variables for Relapse incidence were acute GVHD, chronic GVHD, intensity of the conditioning, salvage status, DRI, reactivation of cytomegalovirus, age and time to engraft ment; co-variables for overall, event-free and GVHDrelapse- free survival were intensity of the conditioning, DRI, HCT-CI, CD34+ cells in the graft , severe sepsis, age and year of transplant.
The subgroup analysis of EFS demonstrated that signifi cant benefi t of PTCy prophylaxis was observed for both RIC (HR 0.57, p=0.0175) and MAC (HR 0.38, p=0.0259), patients with high DRI (HR 0.584, p=0.0385), patients younger than 40 years old (HR 0.497, p=0.0054), patients with acute leukemia (HR=0.545, p=0.089), non-salvage group (HR 0.609, p=0.0493) and donor-recipient pairs other than female to male (HR 0.516, p=0.0077). For the other subgroups, no significant diff erences were noted between PTCy and CNIbased prophylaxis, at least in the current study population (p>0.05), as seen in Fig. 2.

Hazard ratio (HR) heterogeneity was calculated using Cochran’s Q test. Th e size of the marker represents the number of patients in the each subgroup.

Complications of transplantation

There was no difference in liver toxicity (p=0.08), neurotoxicity (p=0.11), incidence of hemorrhagic cystitis (13% vs 14%, p=0.38), veno-occlusive disease (p=0.19), sepsis (p=0.06), severe sepsis (p=0.77), invasive mycosis (p=0.07), CMV reactivation (p=0.84) and “overall” transplant-assocciated microangiopathy (TAM) according to Cho et al criteria (p=0.13) [17]. However, there was reduced incidence of nephrotoxicity in the PTCy group (33% vs 43%, p=0.0079), with no grade 3-4 cases observed in the PTCy group. A reduced incidence of mucositis was revealed aft er PTCy (78% vs 88%, p=0.0059), but grade 3 and 4 mucositis was more frequent in this group (41% vs 34%, p=0.0163). Th ere was a borderline significant increase of sepsis incidence aft er PTCy (29% vs 17%, p=0.0566), but similar incidence of severe sepsis (6% vs 5%, p=0.77).

Discussion

Despite previous reports of feasibility and safety of single-agent PTCy prophylaxis [8, 9] this is the fi rst to our knowledge comparison of this regimen to conventional regimen consisting of CNI and second other agent, like MMF or methotrexate. It should be mentioned that, when compared to previous studies, the incidence of grade II-IV acute GVHD was lower in our cohort (8% vs 43-51%). In the published trials, this could be explained by inclusion of patients with both related and unrelated graft s and by use of myeloablative therapy (MAC) in all the patients. In our study we included only related donors and majority of patients received RIC, which are the known factors that reduce GVHD incidence [18]. In this population of patients receiving predominantly RIC transplantation from related donor, a single-agent PTCy was associated with lower acute, but not chronic GVHD incidence. All of the other outcomes in this cohort were generally comparable to the previous reports [8,9] indicating the reproducibility of the results with single-agent PTCy.

We have observed a moderate superiority of PTCy, both in terms of NRM and relapse incidence, which, however, was translated into a signifi cant benefi t in OS, EFS and GFRS. The mechanisms underlying the improvement of results might include the reduced GVHD-related mortality, lower immunosuppression burden, preservation of certain T-cell antigen-specifi c subpopulations and faster development of graft -versus-leukemia (GVL) eff ect [19, 20]. Interestingly, 30% GRFS in the PTCy group indicate that one-third of the patients are cured without any further need for immunosuppression. However, the results of the study should be interpreted with caution because of its retrospective nature, inhomogeneous patient population, and diff erences in the time of transplant between the groups. Th e question whether single-agent PTCy is better than conventional prophylaxis should be addressed in a prospective clinical trial. The ongoing BMT CTN 1301 trial is addressing this issue, and the study completion is expected in 2021 [21].

The subgroup analysis revealed that the patients that benefit from PTCy are mostly young acute leukemia patients with high DRI. Th is could be explained by larger benefi t of GVL in this population of patients [22]. Absence of diff erences in the other patient populations might be due to a small sample size in these subgroups, since all non-signifi cant diff erences were observed in the smaller proportions of patients than did significant ones.

The analysis of clinical complications has shown a generally comparable safety profi le between PTCy-based and CNIbased prophylaxis. A reduced nephrotoxicity is anticipated, since calcineurin inhibitors are well-known agents causing acute kidney damage [23]. Our group had also reported the reduced TAM incidence in unrelated graft s with PTCy [24], but the diff erences were not statistically signifi cant in this patient cohort despite lower percentage (1% vs 5%). Larger studies are required to demonstrate that reduced acute GVHD incidence and absence of CNIs as well-known risk factors of TAM might diminish its occurence [25]. The alarming trend of higher sepsis incidence aft er PTCy might be a consequence of slower engraftment and longer neutropenia duration, but also, since PTCy group consisted of more recent transplantations, this might be due to improved sepsis diagnostics over time. Th e latter explanation might be more probable, because the incidence of bacteremia recently reported by other groups varies from 24 to 48% [26].

Conclusion

Despite the drawbacks of a single-center retrospective nature, our study in matched related bone marrow recipients has shown a reduced incidence of acute, but not chronic GVHD with single-agent PTCy compared to conventional GVHD prophylaxis. Moreover, the use of PTCy was associated with improved overall and event-free survival. Th ese fi ndings should be confi rmed in multicenter prospective randomized trials.

Financial Disclosure Statement

The authors have nothing to disclaim.

Acknowledgements and conflict of interests

The authors declare no confl ict of interest. We thank our nursing stuff and our patients for making this study possible.

References

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6. Hiraoka A, Ohashi Y, Okamoto S et al. Phase III study comparing tacrolimus (FK506) with cyclosporine for graft-versus-host disease prophylaxis after allogeneic bone marrow transplantation. Bone Marrow Transplant. 2001;28(2):181-185.
7. Inamoto Y, Flowers ME, Appelbaum FR et al. A retrospective comparison of tacrolimus versus cyclosporine with methotrexate for immunosuppression aft er allogeneic hematopoietic cell transplantation with mobilized blood cells. Biol Blood Marrow Transplant. 2011;17(7):1088-1092.
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9. Kanakry CG, O’Donnell PV, Furlong T, de Lima MJ, Wei W, Medeot M et al. Multi-institutional study of post-transplantation cyclophosphamide as single-agent graft -versushost disease prophylaxis aft er allogeneic bone marrow transplantation using myeloablative busulfan and fl udarabine conditioning. J Clin Oncol. 2014;32(31):3497-3505.
10. Kanakry CG, Bolaños-Meade J, Kasamon YL, Zahurak M, Durakovic N, Furlong T et al. Low immunosuppressive burden after HLA-matched related or unrelated
BMT using posttransplantation cyclophosphamide. Blood. 2017;129(10):1389-1393.
11. Kanakry CG, Coff ey DG, Towlerton AM, Vulic A, Storer BE et al. Origin and evolution of the T cell repertoire after posttransplantation cyclophosphamide. JCI Insight. 2016;1(5). pii: e86252. Epub 2016 Apr 21.
12. Przepiorka D, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Th omas ED. 1994 Consensus Conference on Acute GVHD Grading. Bone Marrow Transplant. 1995;15:825–828.
13. Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft -versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005;11:945–956.
14. Sorror ML, Maris MB, Storb R, Baron F, Sandmaier BM, Maloney DG, Storer B. Hematopoietic cell transplantation (HCT)-specifi c comorbidity index: a new tool for risk assessment before allogeneic HCT. Blood. 2005;106(8):2912-2919.
15. Armand P, Kim HT, Logan BR, Wang Z, Alyea EP, Kalaycio ME, Maziarz RT, Antin JH, Soiff er RJ, Weisdorf DJ, Rizzo JD, Horowitz MM, Saber W. Validation and refi nement of the Disease Risk Index for allogeneic stem cell transplantation. Blood. 2014;123(23):3664-3671.
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24. Moiseev IS, Pirogova OV, Alyanski AL, Babenko EV, Gindina TL, Darskaya EI, Slesarchuk OA, Bondarenko SN, Afanasyev BV. Graft -versus-host disease prophylaxis in unrelated peripheral blood stem cell transplantation with post-transplantation cyclophosphamide, tacrolimus, and mycophenolate mofetil. Biol Blood Marrow Transplant. 2016;22(6):1037-1042.
25. Carreras E, Diaz-Ricart M. Th e role of the endothelium in the short-term complications of hematopoietic SCT. Bone Marrow Transplant. 2011;46(12):1495-1502.
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Introduction

Graft-versus-host disease (GVHD) prophylaxis based on calcineurin inhibitors (CNI), namely cyclosporin A and tacrolimus, was developed in 1980s by Donald Th omas group [1] and is still the standard of care in the majority of European centers [2]. Although tacrolimus and cyclosporin A have some diff erences in the effi cacy aft er unrelated hematopoietic stem cell transplantation (HSCT), there are no signifi cant differences between these two agents for matched related graft s in the majority of studies [3,4]. Th is type of prophylaxis results in grade II-IV acute GVHD and chronic GVHD in about 20-40% of patients undergoing HSCT from matched related donors (MRD) [5-7].
A recent study by Luznik et al. demonstrated that post-transplant cyclophosphamide (PTCy) could be used as single-agent GVHD prophylaxis for matched bone marrow graft s with relatively low incidence of acute and chronic GVHD [8]. Th is fi nding was subsequently confi rmed in a multicenter study [9]. Th e single-agent PTCy regimen is associated with low immunosuppression burden and relatively fast immunologic recovery, so it is anticipated to reduce the rate of infectious complications and potentiate graft -versus-leukemia (GVL) eff ect [10, 11]. However, no studies were published with direct comparison of the prophylaxis with CNIs and PTCy as the single agent. Th is retrospective study compares patients transplanted for malignant diseases with these two types of GVHD prophylaxis.

Patients and methods

Patients and transplantation procedures

183 patients transplanted in 2006-2016 at the First St.Petersburg State I. Pavlov Medical University were enrolled in the study. Only first allogeneic transplantations were included. All patients received 10/10 HLA-matched bone marrow graft from related donor. Th e Ethical Committee of Pavlov First St. Petersburg State Medical University approved the usage of PTCy as a single-agent for GVHD prophylaxis. All patients signed informed consent for the use of their medical data to research purposes. 78 subjects received PTCy, and 105 were administered either cyclosporine A or tacrolimus combined with a second immunosuppressive agent. 49% of patients had acute myeloid leukemia; 31%, acute lymphoblastic leukemia (ALL); 8%, chronic myeloid leukemia; 3%, myelodysplastic syndrome, and 8%, malignant lymphomas. 27% of patients underwent salvage transplantation, defi ned as acute leukemia without hematologic remission, chronic myeloid leukemia in blast crisis and lymphomas in less than partial remission status. Comparative clinical characteristics of the two groups are presented in Table 1. PTCy group comprised less ALL patients, less salvage patients and a significantly later year of transplant. Th e other characteristics were comparable. Median follow-up in the control group was 50 months (range 8 to 111); in the PTCy group, 24 months (range 5 to 41).

Transplantation procedures

Myeloablative conditioning (MAC) was performed with oral busulfan at a dose of 16 mg/kg and cyclophosphamide (100-120 mg/kg). Reduced intensity conditioning (RIC) was performed with fl udarabine (180 mg/m2), and busulfan (8 mg/kg). Patients were assigned to RIC if they were 40 years or older, had HSCT-specifi c comorbidity index (HCTCI)≥ 2, grade >3 hepatic toxicity during induction therapy, or uncontrolled infection at the start of conditioning.
GVHD prophylaxis in the PTCy group consisted of single-agent cyclophosphamide (50 mg/kg) administered at days +3, +4. Mesna (50 mg/kg/day) was administered during the days of PTCy infusion. Glucocorticoid administration was prohibited from day -5 until day +5, except of cases with anaphylaxia and severe respiratory failure. In the groups with conventional prophylaxis, the patients received either tacrolimus with target concentrations of 5-15 ng/ml, or cyclosporine A, starting from the day -1, with target concentrations of 150-350 ng/ml. Th e second agent in the prophylaxis regimen was methotrexate administered as a short course (10-15 mg/m2) at days +1,+3,+6, or mycophenolate mofetil (MMF) 30 mg/kg from day -1 to day +30.
Supportive care included omeprasole 40 mg/day, acyclovir 600 mg/day, trimetoprim/sulfamethaxazole 960 mg/day, allopurinol and unfractionated heparin (100 IU/kg/day) starting day -7. In patients without previous history of invasive fungal infection, prophylaxis was done with fl uconazole (400 mg/day) starting on day 0, in patients with history or evidence of invasive aspergillosis, with voriconazole (400 mg/day) starting on day 0. Premedication before graft transfusion in the PTCy group was performed with metamesole 2 g and diphenhydramine 20 mg and steroids 1 mg/kg were added in the conventional prophylaxis group.

Clinical definitions

Time to disease relapse, acute GVHD (GVHD), moderate to severe chronic GVHD (cGVHD), non-relapse mortality (NRM), overall survival (OS), event-free survival (EFS), and GVHD-relapse free survival (GRFS) were defi ned as the time from transplantation to the event. All these parameters were calculated for the two-year interval. Incidence of aGVHD was calculated at 125 days aft er HSCT, and the time frame for the other outcomes was three years. Events for EFS were relapse or death. Events for GRFS were either death, relapse, grade III-IV acute GVHD or systemic therapy-requiring chronic GVHD. Th e Consensus Conference criteria and NIH criteria were used for aGVHD and cGVHD grading, respectively [12, 13]. Primary graft failure was defined as a complete absence of donor chimerism in bone marrow biopsy by day +40. Time to engraft ment was calculated as a time period from HSCT to unsupported neutrophil count of >500/μl and white blood cell count >1000/μl for 3  onsecutive days. Toxicity was assessed with CTCAE ver. 4.03. Sepsis in the study was defi ned as systemic infl ammatory reaction with microbiologically confi rmed bacteremia. Th e multivariate correction was performed with Hematopoietic Cell Transplantation-specifi c Comorbidity Index (HCT-CI) [14] and disease risk index (DRI) by Armand et al. [15].

Statistical Analysis

Comparison of groups was performed by Chi-square test. The survival distributions for OS, EFS, GRFS were calculated using Kaplan-Meier methodology. Th e comparisons were made using the log-rank test. Cumulative incidence analysis with competing risks for aGVHD, cGVHD, relapse incidence and NRM was performed using Gray test. Relapse and NRM were accounted as competing risks. Early discontinuation of immunosuppression due to relapse or minimal residual disease was considered a competing risk for aGVHD. Donor lymphocyte infusion was considered a competing risk for cGVHD. Multivariate analysis was done using proportional hazard regression. Fine and Grey regression was used for the multivariate analysis of cumulative incidences [16]. Factors used for multivariate correction had at least p=0.15 significance in the univariate analysis. Heterogeneities between the hazard ratios in the subgroup analysis were tested for significance using the Cochran’s Q test, with df degrees of freedom. Incidence and severity of complications was compared using Mann-Whitney test. Analyses were conducted in SAS 9.3 (SAS Institute, Inc.).

Results

Engraftment and graft-versus-host disease

Incidence of primary graft failure was not diff erent between groups (1.1 vs 1.6%, p=0.42). Nonetheless, engraft ment in the PTCy group was slower when assessed by neutrophil count (19 vs 24 days, p<0.001) and platelet count (17 vs 23 days, p=0.005). Acute GVHD grade II-IV was significantly less frequent in the PTCy group (8% vs 27%, p=0.0021, multivariate HR 0.239, 95% CI 0.099-0.58). The superiority of PTCy was also observed for grade III-IV acute GVHD (4% vs 15%, p=0.0040, multivariate HR 0.192, 95% CI 0.055-0.666) (Fig. 1). Incidence of grade I acute GVHD was not different (18% vs 13%, p=0.39) in the PTCy and conventional prophylaxis groups, respectively.
Moderate and severe chronic GVHD was not different between PTCy and CNIs groups (26% vs 30%, p=0.938, multivariate HR 0.898, 95% CI 0.477-1.69). Incidence of mild chronic GVHD was also not diff erent (9% vs 10%, p=0.60). Mortality, relapses and survival outcomes NRM was lower in the PTCy group in the univariate analysis (8% vs 22%, p=0.0195), although there was no diff erence when corrected for other variables (HR 0.384, 95% CI 0.089-1.437, p=0.1768). Relapse incidence was not diff erent in the univariate analysis (40% vs 49%, p=0.0896) in the PTCy and CNIs groups, respectively. However, in the multivariate analysis the use of PTCy was associated with lower incidence of relapse (HR 0.519, 95% CI 0.297-0.893, p=0.023). These NRM and relapse incidence borderline improvements translated in superior OS (62% vs 41%, p=0.0027, multivariate HR 0.489, 95% CI 0.261-0.917), EFS (52% vs 31%, p=0.0013, multivariate HR 0.571, 95% CI 0.334-0.976) and GVHD-relapse-free survival (30% vs 12%, p=0.0006, multivariate HR 0.493, 95% CI 0.309-0.786) (Fig. 1).

Unadjusted parameters represent results of univariate analysis; adjusted parameters represent results of multivariate analysis. In the multivariate analyses, co-variables  or acute GVHD were as follows: intensity of the conditioning; age and female donor for male recipient. Co-variable for chronic moderate and severe (m&s) GVHD was only previous acute GVHD; co-variables for NRM were intensity of the conditioning, salvage status, HCT-CI, occurrence of severe sepsis, female donor for male recipient, development of transplant-associated microangiopathy and year of transplant; co-variables for Relapse incidence were acute GVHD, chronic GVHD, intensity of the conditioning, salvage status, DRI, reactivation of cytomegalovirus, age and time to engraft ment; co-variables for overall, event-free and GVHDrelapse- free survival were intensity of the conditioning, DRI, HCT-CI, CD34+ cells in the graft , severe sepsis, age and year of transplant.
The subgroup analysis of EFS demonstrated that signifi cant benefi t of PTCy prophylaxis was observed for both RIC (HR 0.57, p=0.0175) and MAC (HR 0.38, p=0.0259), patients with high DRI (HR 0.584, p=0.0385), patients younger than 40 years old (HR 0.497, p=0.0054), patients with acute leukemia (HR=0.545, p=0.089), non-salvage group (HR 0.609, p=0.0493) and donor-recipient pairs other than female to male (HR 0.516, p=0.0077). For the other subgroups, no significant diff erences were noted between PTCy and CNIbased prophylaxis, at least in the current study population (p>0.05), as seen in Fig. 2.

Hazard ratio (HR) heterogeneity was calculated using Cochran’s Q test. Th e size of the marker represents the number of patients in the each subgroup.

Complications of transplantation

There was no difference in liver toxicity (p=0.08), neurotoxicity (p=0.11), incidence of hemorrhagic cystitis (13% vs 14%, p=0.38), veno-occlusive disease (p=0.19), sepsis (p=0.06), severe sepsis (p=0.77), invasive mycosis (p=0.07), CMV reactivation (p=0.84) and “overall” transplant-assocciated microangiopathy (TAM) according to Cho et al criteria (p=0.13) [17]. However, there was reduced incidence of nephrotoxicity in the PTCy group (33% vs 43%, p=0.0079), with no grade 3-4 cases observed in the PTCy group. A reduced incidence of mucositis was revealed aft er PTCy (78% vs 88%, p=0.0059), but grade 3 and 4 mucositis was more frequent in this group (41% vs 34%, p=0.0163). Th ere was a borderline significant increase of sepsis incidence aft er PTCy (29% vs 17%, p=0.0566), but similar incidence of severe sepsis (6% vs 5%, p=0.77).

Discussion

Despite previous reports of feasibility and safety of single-agent PTCy prophylaxis [8, 9] this is the fi rst to our knowledge comparison of this regimen to conventional regimen consisting of CNI and second other agent, like MMF or methotrexate. It should be mentioned that, when compared to previous studies, the incidence of grade II-IV acute GVHD was lower in our cohort (8% vs 43-51%). In the published trials, this could be explained by inclusion of patients with both related and unrelated graft s and by use of myeloablative therapy (MAC) in all the patients. In our study we included only related donors and majority of patients received RIC, which are the known factors that reduce GVHD incidence [18]. In this population of patients receiving predominantly RIC transplantation from related donor, a single-agent PTCy was associated with lower acute, but not chronic GVHD incidence. All of the other outcomes in this cohort were generally comparable to the previous reports [8,9] indicating the reproducibility of the results with single-agent PTCy.

We have observed a moderate superiority of PTCy, both in terms of NRM and relapse incidence, which, however, was translated into a signifi cant benefi t in OS, EFS and GFRS. The mechanisms underlying the improvement of results might include the reduced GVHD-related mortality, lower immunosuppression burden, preservation of certain T-cell antigen-specifi c subpopulations and faster development of graft -versus-leukemia (GVL) eff ect [19, 20]. Interestingly, 30% GRFS in the PTCy group indicate that one-third of the patients are cured without any further need for immunosuppression. However, the results of the study should be interpreted with caution because of its retrospective nature, inhomogeneous patient population, and diff erences in the time of transplant between the groups. Th e question whether single-agent PTCy is better than conventional prophylaxis should be addressed in a prospective clinical trial. The ongoing BMT CTN 1301 trial is addressing this issue, and the study completion is expected in 2021 [21].

The subgroup analysis revealed that the patients that benefit from PTCy are mostly young acute leukemia patients with high DRI. Th is could be explained by larger benefi t of GVL in this population of patients [22]. Absence of diff erences in the other patient populations might be due to a small sample size in these subgroups, since all non-signifi cant diff erences were observed in the smaller proportions of patients than did significant ones.

The analysis of clinical complications has shown a generally comparable safety profi le between PTCy-based and CNIbased prophylaxis. A reduced nephrotoxicity is anticipated, since calcineurin inhibitors are well-known agents causing acute kidney damage [23]. Our group had also reported the reduced TAM incidence in unrelated graft s with PTCy [24], but the diff erences were not statistically signifi cant in this patient cohort despite lower percentage (1% vs 5%). Larger studies are required to demonstrate that reduced acute GVHD incidence and absence of CNIs as well-known risk factors of TAM might diminish its occurence [25]. The alarming trend of higher sepsis incidence aft er PTCy might be a consequence of slower engraftment and longer neutropenia duration, but also, since PTCy group consisted of more recent transplantations, this might be due to improved sepsis diagnostics over time. Th e latter explanation might be more probable, because the incidence of bacteremia recently reported by other groups varies from 24 to 48% [26].

Conclusion

Despite the drawbacks of a single-center retrospective nature, our study in matched related bone marrow recipients has shown a reduced incidence of acute, but not chronic GVHD with single-agent PTCy compared to conventional GVHD prophylaxis. Moreover, the use of PTCy was associated with improved overall and event-free survival. Th ese fi ndings should be confi rmed in multicenter prospective randomized trials.

Financial Disclosure Statement

The authors have nothing to disclaim.

Acknowledgements and conflict of interests

The authors declare no confl ict of interest. We thank our nursing stuff and our patients for making this study possible.

References

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Моисеев¹,², Ольга В. Пирогова¹, Елена В. Бабенко¹, Елена И. Дарская¹, Елена В. Морозова,¹,², Сергей Н. Бондаренко¹, Борис В. Афанасьев¹,²" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(353) "Иван С. Моисеев¹,², Ольга В. Пирогова¹, Елена В. Бабенко¹, Елена И. Дарская¹, Елена В. Морозова,¹,², Сергей Н. Бондаренко¹, Борис В. 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Р. М. Горбачевой<br> ²Кафедра гематологии, трансфузиологии и трансплантологии, Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова, Санкт-Петербург, Россия" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(498) "¹НИИ детской онкологии, гематологии и трансплантологии им. Р. М. Горбачевой
²Кафедра гематологии, трансфузиологии и трансплантологии, Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова, Санкт-Петербург, Россия" ["TYPE"]=> string(4) "HTML" } ["~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) "20023" ["VALUE"]=> array(2) { ["TEXT"]=> string(4071) "<p style="text-align: justify;"> В настоящий момент опубликован ряд исследований, показавших эффективность профилактики реакции «трансплантат против хозяина» (РТПХ) с использованием пост-трансплантационного циклофосфана в качестве единственного препарата (моноПТЦф) при HLA-совместимых трансплантациях костного мозга (ТКМ). Тем не менее, до сих пор не было опубликовано прямых сравнений эффективности моноПТЦф и классической профилактики с использованием ингибиторов кальциневрина (ИКН). В данном исследовании проведено сравнение результатов ТКМ у 78 пациентов, получавших профилактику РТПХ с использованием моноПТЦф, и 105 пациентов исторического контроля, получавших профилактику такролимусом/циклоспорином А и микофенолатом мофетилом/метотрексатом. Исследуемые группы были сравнимы по клиническим характеристикам, однако в группе с ИКН было больше пациентов группы «спасения» и больший процент пациентов с острым лимфобластным лейкозом. ПТЦф достоверно лучше предотвращал развитие острой РТПХ II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) и III-IV степени (HR 0.192, 95% CI 0.055-0.666, p=0.009), а также снижал вероятность рецидива (HR 0.519, 95% CI 0.297-0.893, p=0.023). Частота хронической РТПХ (HR 0.898, 95% CI 0.477-1.69, p=0.74) и трансплантационной летальности (HR 0.384, 95% CI 0.089-1.437, p=0.1768) достоверно не различались между группами. В группе пациентов с моноПТЦф наблюдалась достоверно более высокая общая выживаемость (HR 0.489, 95% CI 0.261-0.917, p=0.03), бессобытийная выживаемость (HR 0.571, 95% CI 0.334-0.976, p=0.04) и выживаемость без рецидива и РТПХ (HR 0.493, 95% CI 0.309-0.786, p=0.003). Токсичность ТКМ была сравнима в двух группах, за исключения меньшей нефротоксичности (33% против 43%, p=0.008) и частоты пост-трансплантационной микроангиопатии (3% против 11%, p=0.04) режима с ПТЦф, и большей частотой мукозитов 3-4 степени при данном режиме (41% против 34%, p=0.02). Несмотря на недостатки ретроспективного и одноцентрового подхода, в данном исследовании было показано преимущество режима профилактики РТПХ на основе моноПТЦф. Полученные результаты должны быть подтверждены в проспективном рандомизированном исследовании. </p> <h2 style="text-align: justify;">Ключевые слова</h2> <p style="text-align: justify;"> Трансплантация костного мозга, реакция «трансплантат против хозяина», пост-трансплантационный циклофосфан, профилактика. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(4005) "

В настоящий момент опубликован ряд исследований, показавших эффективность профилактики реакции «трансплантат против хозяина» (РТПХ) с использованием пост-трансплантационного циклофосфана в качестве единственного препарата (моноПТЦф) при HLA-совместимых трансплантациях костного мозга (ТКМ). Тем не менее, до сих пор не было опубликовано прямых сравнений эффективности моноПТЦф и классической профилактики с использованием ингибиторов кальциневрина (ИКН). В данном исследовании проведено сравнение результатов ТКМ у 78 пациентов, получавших профилактику РТПХ с использованием моноПТЦф, и 105 пациентов исторического контроля, получавших профилактику такролимусом/циклоспорином А и микофенолатом мофетилом/метотрексатом. Исследуемые группы были сравнимы по клиническим характеристикам, однако в группе с ИКН было больше пациентов группы «спасения» и больший процент пациентов с острым лимфобластным лейкозом. ПТЦф достоверно лучше предотвращал развитие острой РТПХ II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) и III-IV степени (HR 0.192, 95% CI 0.055-0.666, p=0.009), а также снижал вероятность рецидива (HR 0.519, 95% CI 0.297-0.893, p=0.023). Частота хронической РТПХ (HR 0.898, 95% CI 0.477-1.69, p=0.74) и трансплантационной летальности (HR 0.384, 95% CI 0.089-1.437, p=0.1768) достоверно не различались между группами. В группе пациентов с моноПТЦф наблюдалась достоверно более высокая общая выживаемость (HR 0.489, 95% CI 0.261-0.917, p=0.03), бессобытийная выживаемость (HR 0.571, 95% CI 0.334-0.976, p=0.04) и выживаемость без рецидива и РТПХ (HR 0.493, 95% CI 0.309-0.786, p=0.003). Токсичность ТКМ была сравнима в двух группах, за исключения меньшей нефротоксичности (33% против 43%, p=0.008) и частоты пост-трансплантационной микроангиопатии (3% против 11%, p=0.04) режима с ПТЦф, и большей частотой мукозитов 3-4 степени при данном режиме (41% против 34%, p=0.02). Несмотря на недостатки ретроспективного и одноцентрового подхода, в данном исследовании было показано преимущество режима профилактики РТПХ на основе моноПТЦф. Полученные результаты должны быть подтверждены в проспективном рандомизированном исследовании.

Ключевые слова

Трансплантация костного мозга, реакция «трансплантат против хозяина», пост-трансплантационный циклофосфан, профилактика.

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²Chair of Hematology, Transfusiology and Transplantation, Pavlov First St. Petersburg State Medical University, St. Petersburg, Russian Federation" ["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) "20027" ["VALUE"]=> array(2) { ["TEXT"]=> string(2134) "<p style="text-align: justify;"> A number of studies were published demonstrating efficacy of single-agent graft-versus-host disease prophylaxis (GVHD) with post-transplantation cyclophosphamide (saPTCy) in matched related bone marrow transplantations (BMT), however no comparisons were published so far between saPTCy and conventional GVHD prophylaxis based on calcineurin inhibitors (CNIs). In this study, 78 patients graft ed with bone marrow from matched related donor (MRD) with saPTCy GVHD prophylaxis were compared to 105 historical control patients also receiving bone marrow from MRD, but with tacrolimus/cyclosporine A and mycophenolate mofetil/methotrexate prophylaxis. Groups were comparable in pre-transplant characteristics of patients, except higher prevalence of salvage patients and acute lymphoblastic leukemia in CNIs cohort. PTCy was superior to CNIs in prevention of grade II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) and grade III-IV acute GVHD (HR 0.192, 95% CI 0.055-0.666, p=0.009), relapse (HR 0.519, 95% CI 0.297-0.893, p=0.023). No difference was observed for moderate and severe chronic GVHD (HR 0.898, 95% CI 0.477-1.69, p=0.74) and non-relapse mortality (HR 0.384, 95% CI 0.089-1.437, p=0.1768). Patients after saPTCy had improved overall survival (HR 0.489, 95% CI 0.261-0.917, p=0.03), event-free-survival (HR 0.571, 95% CI 0.334-0.976, p=0.04) and GVHD-relapse-free survival (HR 0.493, 95% CI 0.309-0.786, p=0.003). Th e toxicity of BMT was generally comparable, except lower incidence of nephrotoxicity (33% vs 43%, p=0.008) aft er PTCy, but with higher incidence of grade 3-4 mucositis in this group (41% vs 34%, p=0.02). Despite limitations of single-center retrospective design, this study demonstrated superiority of saPTCy vs CNI-based prophylaxis, but these results should be confirmed in prospective randomized trials. </p> <h2 style="text-align: justify;">Keywords</h2> <p style="text-align: justify;"> Bone marrow transplantation, graft-versus-host disease, post-transplantation cyclophosphamide, prophylaxis. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2068) "

A number of studies were published demonstrating efficacy of single-agent graft-versus-host disease prophylaxis (GVHD) with post-transplantation cyclophosphamide (saPTCy) in matched related bone marrow transplantations (BMT), however no comparisons were published so far between saPTCy and conventional GVHD prophylaxis based on calcineurin inhibitors (CNIs). In this study, 78 patients graft ed with bone marrow from matched related donor (MRD) with saPTCy GVHD prophylaxis were compared to 105 historical control patients also receiving bone marrow from MRD, but with tacrolimus/cyclosporine A and mycophenolate mofetil/methotrexate prophylaxis. Groups were comparable in pre-transplant characteristics of patients, except higher prevalence of salvage patients and acute lymphoblastic leukemia in CNIs cohort. PTCy was superior to CNIs in prevention of grade II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) and grade III-IV acute GVHD (HR 0.192, 95% CI 0.055-0.666, p=0.009), relapse (HR 0.519, 95% CI 0.297-0.893, p=0.023). No difference was observed for moderate and severe chronic GVHD (HR 0.898, 95% CI 0.477-1.69, p=0.74) and non-relapse mortality (HR 0.384, 95% CI 0.089-1.437, p=0.1768). Patients after saPTCy had improved overall survival (HR 0.489, 95% CI 0.261-0.917, p=0.03), event-free-survival (HR 0.571, 95% CI 0.334-0.976, p=0.04) and GVHD-relapse-free survival (HR 0.493, 95% CI 0.309-0.786, p=0.003). Th e toxicity of BMT was generally comparable, except lower incidence of nephrotoxicity (33% vs 43%, p=0.008) aft er PTCy, but with higher incidence of grade 3-4 mucositis in this group (41% vs 34%, p=0.02). Despite limitations of single-center retrospective design, this study demonstrated superiority of saPTCy vs CNI-based prophylaxis, but these results should be confirmed in prospective randomized trials.

Keywords

Bone marrow transplantation, graft-versus-host disease, post-transplantation cyclophosphamide, prophylaxis.

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Moiseev¹,², Olga V. Pirogova¹, Elena V. Babenko¹, Tatyana L. Gindina¹, Elena I. Darskaya¹, Elena V. Morozova¹,², Sergey N. Bondarenko¹, Boris V. Afanasyev¹,²<br>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(290) "Ivan S. Moiseev¹,², Olga V. Pirogova¹, Elena V. Babenko¹, Tatyana L. Gindina¹, Elena I. Darskaya¹, Elena V. Morozova¹,², Sergey N. Bondarenko¹, Boris V. Afanasyev¹,²
" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(6) "Author" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(290) "Ivan S. Moiseev¹,², Olga V. Pirogova¹, Elena V. Babenko¹, Tatyana L. Gindina¹, Elena I. Darskaya¹, Elena V. Morozova¹,², Sergey N. Bondarenko¹, Boris V. Afanasyev¹,²
" } ["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) "20027" ["VALUE"]=> array(2) { ["TEXT"]=> string(2134) "<p style="text-align: justify;"> A number of studies were published demonstrating efficacy of single-agent graft-versus-host disease prophylaxis (GVHD) with post-transplantation cyclophosphamide (saPTCy) in matched related bone marrow transplantations (BMT), however no comparisons were published so far between saPTCy and conventional GVHD prophylaxis based on calcineurin inhibitors (CNIs). In this study, 78 patients graft ed with bone marrow from matched related donor (MRD) with saPTCy GVHD prophylaxis were compared to 105 historical control patients also receiving bone marrow from MRD, but with tacrolimus/cyclosporine A and mycophenolate mofetil/methotrexate prophylaxis. Groups were comparable in pre-transplant characteristics of patients, except higher prevalence of salvage patients and acute lymphoblastic leukemia in CNIs cohort. PTCy was superior to CNIs in prevention of grade II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) and grade III-IV acute GVHD (HR 0.192, 95% CI 0.055-0.666, p=0.009), relapse (HR 0.519, 95% CI 0.297-0.893, p=0.023). No difference was observed for moderate and severe chronic GVHD (HR 0.898, 95% CI 0.477-1.69, p=0.74) and non-relapse mortality (HR 0.384, 95% CI 0.089-1.437, p=0.1768). Patients after saPTCy had improved overall survival (HR 0.489, 95% CI 0.261-0.917, p=0.03), event-free-survival (HR 0.571, 95% CI 0.334-0.976, p=0.04) and GVHD-relapse-free survival (HR 0.493, 95% CI 0.309-0.786, p=0.003). Th e toxicity of BMT was generally comparable, except lower incidence of nephrotoxicity (33% vs 43%, p=0.008) aft er PTCy, but with higher incidence of grade 3-4 mucositis in this group (41% vs 34%, p=0.02). Despite limitations of single-center retrospective design, this study demonstrated superiority of saPTCy vs CNI-based prophylaxis, but these results should be confirmed in prospective randomized trials. </p> <h2 style="text-align: justify;">Keywords</h2> <p style="text-align: justify;"> Bone marrow transplantation, graft-versus-host disease, post-transplantation cyclophosphamide, prophylaxis. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(2068) "

A number of studies were published demonstrating efficacy of single-agent graft-versus-host disease prophylaxis (GVHD) with post-transplantation cyclophosphamide (saPTCy) in matched related bone marrow transplantations (BMT), however no comparisons were published so far between saPTCy and conventional GVHD prophylaxis based on calcineurin inhibitors (CNIs). In this study, 78 patients graft ed with bone marrow from matched related donor (MRD) with saPTCy GVHD prophylaxis were compared to 105 historical control patients also receiving bone marrow from MRD, but with tacrolimus/cyclosporine A and mycophenolate mofetil/methotrexate prophylaxis. Groups were comparable in pre-transplant characteristics of patients, except higher prevalence of salvage patients and acute lymphoblastic leukemia in CNIs cohort. PTCy was superior to CNIs in prevention of grade II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) and grade III-IV acute GVHD (HR 0.192, 95% CI 0.055-0.666, p=0.009), relapse (HR 0.519, 95% CI 0.297-0.893, p=0.023). No difference was observed for moderate and severe chronic GVHD (HR 0.898, 95% CI 0.477-1.69, p=0.74) and non-relapse mortality (HR 0.384, 95% CI 0.089-1.437, p=0.1768). Patients after saPTCy had improved overall survival (HR 0.489, 95% CI 0.261-0.917, p=0.03), event-free-survival (HR 0.571, 95% CI 0.334-0.976, p=0.04) and GVHD-relapse-free survival (HR 0.493, 95% CI 0.309-0.786, p=0.003). Th e toxicity of BMT was generally comparable, except lower incidence of nephrotoxicity (33% vs 43%, p=0.008) aft er PTCy, but with higher incidence of grade 3-4 mucositis in this group (41% vs 34%, p=0.02). Despite limitations of single-center retrospective design, this study demonstrated superiority of saPTCy vs CNI-based prophylaxis, but these results should be confirmed in prospective randomized trials.

Keywords

Bone marrow transplantation, graft-versus-host disease, post-transplantation cyclophosphamide, prophylaxis.

" ["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(2068) "

A number of studies were published demonstrating efficacy of single-agent graft-versus-host disease prophylaxis (GVHD) with post-transplantation cyclophosphamide (saPTCy) in matched related bone marrow transplantations (BMT), however no comparisons were published so far between saPTCy and conventional GVHD prophylaxis based on calcineurin inhibitors (CNIs). In this study, 78 patients graft ed with bone marrow from matched related donor (MRD) with saPTCy GVHD prophylaxis were compared to 105 historical control patients also receiving bone marrow from MRD, but with tacrolimus/cyclosporine A and mycophenolate mofetil/methotrexate prophylaxis. Groups were comparable in pre-transplant characteristics of patients, except higher prevalence of salvage patients and acute lymphoblastic leukemia in CNIs cohort. PTCy was superior to CNIs in prevention of grade II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) and grade III-IV acute GVHD (HR 0.192, 95% CI 0.055-0.666, p=0.009), relapse (HR 0.519, 95% CI 0.297-0.893, p=0.023). No difference was observed for moderate and severe chronic GVHD (HR 0.898, 95% CI 0.477-1.69, p=0.74) and non-relapse mortality (HR 0.384, 95% CI 0.089-1.437, p=0.1768). Patients after saPTCy had improved overall survival (HR 0.489, 95% CI 0.261-0.917, p=0.03), event-free-survival (HR 0.571, 95% CI 0.334-0.976, p=0.04) and GVHD-relapse-free survival (HR 0.493, 95% CI 0.309-0.786, p=0.003). Th e toxicity of BMT was generally comparable, except lower incidence of nephrotoxicity (33% vs 43%, p=0.008) aft er PTCy, but with higher incidence of grade 3-4 mucositis in this group (41% vs 34%, p=0.02). Despite limitations of single-center retrospective design, this study demonstrated superiority of saPTCy vs CNI-based prophylaxis, but these results should be confirmed in prospective randomized trials.

Keywords

Bone marrow transplantation, graft-versus-host disease, post-transplantation cyclophosphamide, prophylaxis.

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²Chair of Hematology, Transfusiology and Transplantation, Pavlov First St. Petersburg State Medical University, St. Petersburg, Russian Federation" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Organization" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(320) "¹R. M. Gorbacheva Memorial Institute of Children Hematology, Oncology and Transplantation, Pavlov First Saint Petersburg State Medical University
²Chair of Hematology, Transfusiology and Transplantation, Pavlov First St. Petersburg State Medical University, St. Petersburg, Russian Federation" } ["AUTHOR_RU"]=> array(37) { ["ID"]=> string(2) "25" ["TIMESTAMP_X"]=> string(19) "2015-09-02 18:01:20" ["IBLOCK_ID"]=> string(1) "2" ["NAME"]=> string(12) "Авторы" ["ACTIVE"]=> string(1) "Y" ["SORT"]=> string(3) "500" ["CODE"]=> string(9) "AUTHOR_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) "25" ["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) "20021" ["VALUE"]=> array(2) { ["TEXT"]=> string(473) "Иван С. Моисеев¹,², Ольга В. Пирогова¹, Елена В. Бабенко¹, Елена И. Дарская¹, Елена В. Морозова,¹,², Сергей Н. Бондаренко¹, Борис В. Афанасьев¹,²" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(353) "Иван С. Моисеев¹,², Ольга В. Пирогова¹, Елена В. Бабенко¹, Елена И. Дарская¹, Елена В. Морозова,¹,², Сергей Н. Бондаренко¹, Борис В. Афанасьев¹,²" ["TYPE"]=> string(4) "HTML" } ["~DESCRIPTION"]=> string(0) "" ["~NAME"]=> string(12) "Авторы" ["~DEFAULT_VALUE"]=> array(2) { ["TEXT"]=> string(0) "" ["TYPE"]=> string(4) "HTML" } ["DISPLAY_VALUE"]=> string(353) "Иван С. Моисеев¹,², Ольга В. Пирогова¹, Елена В. Бабенко¹, Елена И. Дарская¹, Елена В. Морозова,¹,², Сергей Н. Бондаренко¹, Борис В. Афанасьев¹,²" } ["SUMMARY_RU"]=> array(37) { ["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) "20023" ["VALUE"]=> array(2) { ["TEXT"]=> string(4071) "<p style="text-align: justify;"> В настоящий момент опубликован ряд исследований, показавших эффективность профилактики реакции «трансплантат против хозяина» (РТПХ) с использованием пост-трансплантационного циклофосфана в качестве единственного препарата (моноПТЦф) при HLA-совместимых трансплантациях костного мозга (ТКМ). Тем не менее, до сих пор не было опубликовано прямых сравнений эффективности моноПТЦф и классической профилактики с использованием ингибиторов кальциневрина (ИКН). В данном исследовании проведено сравнение результатов ТКМ у 78 пациентов, получавших профилактику РТПХ с использованием моноПТЦф, и 105 пациентов исторического контроля, получавших профилактику такролимусом/циклоспорином А и микофенолатом мофетилом/метотрексатом. Исследуемые группы были сравнимы по клиническим характеристикам, однако в группе с ИКН было больше пациентов группы «спасения» и больший процент пациентов с острым лимфобластным лейкозом. ПТЦф достоверно лучше предотвращал развитие острой РТПХ II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) и III-IV степени (HR 0.192, 95% CI 0.055-0.666, p=0.009), а также снижал вероятность рецидива (HR 0.519, 95% CI 0.297-0.893, p=0.023). Частота хронической РТПХ (HR 0.898, 95% CI 0.477-1.69, p=0.74) и трансплантационной летальности (HR 0.384, 95% CI 0.089-1.437, p=0.1768) достоверно не различались между группами. В группе пациентов с моноПТЦф наблюдалась достоверно более высокая общая выживаемость (HR 0.489, 95% CI 0.261-0.917, p=0.03), бессобытийная выживаемость (HR 0.571, 95% CI 0.334-0.976, p=0.04) и выживаемость без рецидива и РТПХ (HR 0.493, 95% CI 0.309-0.786, p=0.003). Токсичность ТКМ была сравнима в двух группах, за исключения меньшей нефротоксичности (33% против 43%, p=0.008) и частоты пост-трансплантационной микроангиопатии (3% против 11%, p=0.04) режима с ПТЦф, и большей частотой мукозитов 3-4 степени при данном режиме (41% против 34%, p=0.02). Несмотря на недостатки ретроспективного и одноцентрового подхода, в данном исследовании было показано преимущество режима профилактики РТПХ на основе моноПТЦф. Полученные результаты должны быть подтверждены в проспективном рандомизированном исследовании. </p> <h2 style="text-align: justify;">Ключевые слова</h2> <p style="text-align: justify;"> Трансплантация костного мозга, реакция «трансплантат против хозяина», пост-трансплантационный циклофосфан, профилактика. </p>" ["TYPE"]=> string(4) "HTML" } ["DESCRIPTION"]=> string(0) "" ["VALUE_ENUM"]=> NULL ["VALUE_XML_ID"]=> NULL ["VALUE_SORT"]=> NULL ["~VALUE"]=> array(2) { ["TEXT"]=> string(4005) "

В настоящий момент опубликован ряд исследований, показавших эффективность профилактики реакции «трансплантат против хозяина» (РТПХ) с использованием пост-трансплантационного циклофосфана в качестве единственного препарата (моноПТЦф) при HLA-совместимых трансплантациях костного мозга (ТКМ). Тем не менее, до сих пор не было опубликовано прямых сравнений эффективности моноПТЦф и классической профилактики с использованием ингибиторов кальциневрина (ИКН). В данном исследовании проведено сравнение результатов ТКМ у 78 пациентов, получавших профилактику РТПХ с использованием моноПТЦф, и 105 пациентов исторического контроля, получавших профилактику такролимусом/циклоспорином А и микофенолатом мофетилом/метотрексатом. Исследуемые группы были сравнимы по клиническим характеристикам, однако в группе с ИКН было больше пациентов группы «спасения» и больший процент пациентов с острым лимфобластным лейкозом. ПТЦф достоверно лучше предотвращал развитие острой РТПХ II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) и III-IV степени (HR 0.192, 95% CI 0.055-0.666, p=0.009), а также снижал вероятность рецидива (HR 0.519, 95% CI 0.297-0.893, p=0.023). Частота хронической РТПХ (HR 0.898, 95% CI 0.477-1.69, p=0.74) и трансплантационной летальности (HR 0.384, 95% CI 0.089-1.437, p=0.1768) достоверно не различались между группами. В группе пациентов с моноПТЦф наблюдалась достоверно более высокая общая выживаемость (HR 0.489, 95% CI 0.261-0.917, p=0.03), бессобытийная выживаемость (HR 0.571, 95% CI 0.334-0.976, p=0.04) и выживаемость без рецидива и РТПХ (HR 0.493, 95% CI 0.309-0.786, p=0.003). Токсичность ТКМ была сравнима в двух группах, за исключения меньшей нефротоксичности (33% против 43%, p=0.008) и частоты пост-трансплантационной микроангиопатии (3% против 11%, p=0.04) режима с ПТЦф, и большей частотой мукозитов 3-4 степени при данном режиме (41% против 34%, p=0.02). Несмотря на недостатки ретроспективного и одноцентрового подхода, в данном исследовании было показано преимущество режима профилактики РТПХ на основе моноПТЦф. Полученные результаты должны быть подтверждены в проспективном рандомизированном исследовании.

Ключевые слова

Трансплантация костного мозга, реакция «трансплантат против хозяина», пост-трансплантационный циклофосфан, профилактика.

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В настоящий момент опубликован ряд исследований, показавших эффективность профилактики реакции «трансплантат против хозяина» (РТПХ) с использованием пост-трансплантационного циклофосфана в качестве единственного препарата (моноПТЦф) при HLA-совместимых трансплантациях костного мозга (ТКМ). Тем не менее, до сих пор не было опубликовано прямых сравнений эффективности моноПТЦф и классической профилактики с использованием ингибиторов кальциневрина (ИКН). В данном исследовании проведено сравнение результатов ТКМ у 78 пациентов, получавших профилактику РТПХ с использованием моноПТЦф, и 105 пациентов исторического контроля, получавших профилактику такролимусом/циклоспорином А и микофенолатом мофетилом/метотрексатом. Исследуемые группы были сравнимы по клиническим характеристикам, однако в группе с ИКН было больше пациентов группы «спасения» и больший процент пациентов с острым лимфобластным лейкозом. ПТЦф достоверно лучше предотвращал развитие острой РТПХ II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) и III-IV степени (HR 0.192, 95% CI 0.055-0.666, p=0.009), а также снижал вероятность рецидива (HR 0.519, 95% CI 0.297-0.893, p=0.023). Частота хронической РТПХ (HR 0.898, 95% CI 0.477-1.69, p=0.74) и трансплантационной летальности (HR 0.384, 95% CI 0.089-1.437, p=0.1768) достоверно не различались между группами. В группе пациентов с моноПТЦф наблюдалась достоверно более высокая общая выживаемость (HR 0.489, 95% CI 0.261-0.917, p=0.03), бессобытийная выживаемость (HR 0.571, 95% CI 0.334-0.976, p=0.04) и выживаемость без рецидива и РТПХ (HR 0.493, 95% CI 0.309-0.786, p=0.003). Токсичность ТКМ была сравнима в двух группах, за исключения меньшей нефротоксичности (33% против 43%, p=0.008) и частоты пост-трансплантационной микроангиопатии (3% против 11%, p=0.04) режима с ПТЦф, и большей частотой мукозитов 3-4 степени при данном режиме (41% против 34%, p=0.02). Несмотря на недостатки ретроспективного и одноцентрового подхода, в данном исследовании было показано преимущество режима профилактики РТПХ на основе моноПТЦф. Полученные результаты должны быть подтверждены в проспективном рандомизированном исследовании.

Ключевые слова

Трансплантация костного мозга, реакция «трансплантат против хозяина», пост-трансплантационный циклофосфан, профилактика.

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                    [TEXT] => <p style="text-align: justify;">
	 Пациенты, инфицированные вирусом иммунодефицита человека (ВИЧ) находятся в группе повышенного риска развития неходжскинских лимфом и лимфомы Ходжкина. При внедрении высокоактивной антиретровирусной терапии (ВААРТ) продемонстрировано, что аутологичная трансплантация стволовых клеток (ауто-ТГСК) является приемлемым, безопасный и эффективным методом лечения пациентов с лимфомами на фоне ВИЧ. Однако количество сравнительных исследований влияния статуса ВИЧ на результаты ауто-ТГСК ограничено. Мы представляем исследование, целью которого является оценить безопасность и эффективность высокодозной химиотерапии с ауто-ТГСК у пациентов с лимфомами на фоне ВИЧ. С января 2016 года выполнены ауто-ТГСК семи пациентам с ВИЧ-ассоциированными лимфомами. Для проведения сравнительного анализа, в исследование включены 28 пациентов с лимфомами без ВИЧ инфекции, которым выполнена ауто-ТГСК в тот же период времени (группа контроля, в соотношении 1:4). Проводилась сравнительная оценка общей 1-годичной выживаемости, восстановления кроветворения, токсичности, выживаемости без прогрессирования и кумулятивной частоты рецидивов/прогрессирования в течение одного года после ауто-ТГСК. Общая выживаемость в течение одного года после ауто-ТГСК у пациентов с ВИЧ-ассоциированными лимфомами составила 100%, выживаемость без прогрессирования – 85,7%, частота рецидивов – 14,3% и не отличалась от группы сравнения. При анализе токсичности и скорости восстановления кроветворения значимых различий в группах сравнения не обнаружено. Предварительные данные подтверждают, что ВИЧ статус не влияет на результаты ауто-ТГСК для лечения лимфом, и поэтому наличие ВИЧ-инфекции само по себе, не должно влиять на принятие решения о проведении высокодозной химиотерапии с аутологичной трансплантацией гемопоэтических стволовых клеток.
</p>
<h2 style="text-align: justify;">Ключевые слова</h2>
<p style="text-align: justify;">
	 Аутологичная трансплантация гемопоэтических стволовых клеток, ВИЧ, ВИЧ-ассоциированные лимфомы, высокодозная химиотерапия, неходжкинские лимфомы, лимфома Ходжкина, сравнительное исследование «случай-контроль».
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	 Пациенты, инфицированные вирусом иммунодефицита человека (ВИЧ) находятся в группе повышенного риска развития неходжскинских лимфом и лимфомы Ходжкина. При внедрении высокоактивной антиретровирусной терапии (ВААРТ) продемонстрировано, что аутологичная трансплантация стволовых клеток (ауто-ТГСК) является приемлемым, безопасный и эффективным методом лечения пациентов с лимфомами на фоне ВИЧ. Однако количество сравнительных исследований влияния статуса ВИЧ на результаты ауто-ТГСК ограничено. Мы представляем исследование, целью которого является оценить безопасность и эффективность высокодозной химиотерапии с ауто-ТГСК у пациентов с лимфомами на фоне ВИЧ. С января 2016 года выполнены ауто-ТГСК семи пациентам с ВИЧ-ассоциированными лимфомами. Для проведения сравнительного анализа, в исследование включены 28 пациентов с лимфомами без ВИЧ инфекции, которым выполнена ауто-ТГСК в тот же период времени (группа контроля, в соотношении 1:4). Проводилась сравнительная оценка общей 1-годичной выживаемости, восстановления кроветворения, токсичности, выживаемости без прогрессирования и кумулятивной частоты рецидивов/прогрессирования в течение одного года после ауто-ТГСК. Общая выживаемость в течение одного года после ауто-ТГСК у пациентов с ВИЧ-ассоциированными лимфомами составила 100%, выживаемость без прогрессирования – 85,7%, частота рецидивов – 14,3% и не отличалась от группы сравнения. При анализе токсичности и скорости восстановления кроветворения значимых различий в группах сравнения не обнаружено. Предварительные данные подтверждают, что ВИЧ статус не влияет на результаты ауто-ТГСК для лечения лимфом, и поэтому наличие ВИЧ-инфекции само по себе, не должно влиять на принятие решения о проведении высокодозной химиотерапии с аутологичной трансплантацией гемопоэтических стволовых клеток.

Ключевые слова

	 Аутологичная трансплантация гемопоэтических стволовых клеток, ВИЧ, ВИЧ-ассоциированные лимфомы, высокодозная химиотерапия, неходжкинские лимфомы, лимфома Ходжкина, сравнительное исследование «случай-контроль».

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	 Human immunodefi ciency virus (HIV) infection is associated with an increased incidence of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Throughout the HAART era, autologous stem cell transplantation (ASCT) has been reported as a feasible, safe, and useful approach to either rescue or consolidate HIV-related lymphoma patients. However, the number of published comparative studies according to the HIV status is limited. Th e aim of the study was to estimate the early safety and effi cacy of high-dose chemotherapy followed by autologous hematopoietic cell transplantation in HIV-related lymphoma. Since the Jan 2016 seven patients with HIV-related lymphoma who have undergone ASCT were included in the prospective singe centre study (study group – HIV group, n=7). T e data of the non-HIV-infected patients with lymphoma who have undergone ASCT at the same period of time (control group, n=28) were collected to compare the efficacy and safety of the procedure (ratio 1:4). Median follow up time was 12 (1-20) months in study group and 8 (1-20) months in control group. The primary endpoint was overall survival (OS) at 12 months after ASCT. Secondary end points were hematopoietic recovery and organ toxicity, progression free survival (PFS) and relapse rate at 12 months aft er ASCT. Here we report the early results of a single institution (EBMT center CIC725) matched case-control study. Th is was an observation trial designed to prospectively evaluate the safety and eff ectiveness of ASCT for patients with HIV-related lymphoma. One-year overall survival in patients with HIV-related lymphoma was 100%, the probability of PFS – 85,7%, relapse rate – 14,3% and did not diff er from the control group. There were not found statistical signifi cant diff erences between two groups in hematopoietic recovery and toxicity rate. Preliminary data provide further evidence that HIV status does not affect the outcome of ASCT for lymphoma, and therefore HIV status alone should no longer exclude these patients from transplant clinical trials.
</p>
<h2 style="text-align: justify;">Keywords</h2>
<p style="text-align: justify;">
	 Autologous hematopoietic cell transplantation, HIV, HIV-related lymphoma, high-dose chemotherapy, non-Hodgkin lymphoma, Hodgkin lymphoma, matched case-control study.
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	 Human immunodefi ciency virus (HIV) infection is associated with an increased incidence of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL). Throughout the HAART era, autologous stem cell transplantation (ASCT) has been reported as a feasible, safe, and useful approach to either rescue or consolidate HIV-related lymphoma patients. However, the number of published comparative studies according to the HIV status is limited. Th e aim of the study was to estimate the early safety and effi cacy of high-dose chemotherapy followed by autologous hematopoietic cell transplantation in HIV-related lymphoma. Since the Jan 2016 seven patients with HIV-related lymphoma who have undergone ASCT were included in the prospective singe centre study (study group – HIV group, n=7). T e data of the non-HIV-infected patients with lymphoma who have undergone ASCT at the same period of time (control group, n=28) were collected to compare the efficacy and safety of the procedure (ratio 1:4). Median follow up time was 12 (1-20) months in study group and 8 (1-20) months in control group. The primary endpoint was overall survival (OS) at 12 months after ASCT. Secondary end points were hematopoietic recovery and organ toxicity, progression free survival (PFS) and relapse rate at 12 months aft er ASCT. Here we report the early results of a single institution (EBMT center CIC725) matched case-control study. Th is was an observation trial designed to prospectively evaluate the safety and eff ectiveness of ASCT for patients with HIV-related lymphoma. One-year overall survival in patients with HIV-related lymphoma was 100%, the probability of PFS – 85,7%, relapse rate – 14,3% and did not diff er from the control group. There were not found statistical signifi cant diff erences between two groups in hematopoietic recovery and toxicity rate. Preliminary data provide further evidence that HIV status does not affect the outcome of ASCT for lymphoma, and therefore HIV status alone should no longer exclude these patients from transplant clinical trials.

Keywords

	 Autologous hematopoietic cell transplantation, HIV, HIV-related lymphoma, high-dose chemotherapy, non-Hodgkin lymphoma, Hodgkin lymphoma, matched case-control study.

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 <sup>2</sup>Кафедра гематологии, трансфузиологии и трансплантологии, Первый Санкт-Петербургский государственный медицинский университет имени академика И. П. Павлова, Санкт-Петербург, Россия
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	 В настоящий момент опубликован ряд исследований, показавших эффективность профилактики реакции «трансплантат против хозяина» (РТПХ) с использованием пост-трансплантационного циклофосфана в качестве единственного препарата (моноПТЦф) при HLA-совместимых трансплантациях костного мозга (ТКМ). Тем не менее, до сих пор не было опубликовано прямых сравнений эффективности моноПТЦф и классической профилактики с использованием ингибиторов кальциневрина (ИКН). В данном исследовании проведено сравнение результатов ТКМ у 78 пациентов, получавших профилактику РТПХ с использованием моноПТЦф, и 105 пациентов исторического контроля, получавших профилактику такролимусом/циклоспорином А и микофенолатом мофетилом/метотрексатом. Исследуемые группы были сравнимы по клиническим характеристикам, однако в группе с ИКН было больше пациентов группы «спасения» и больший процент пациентов с острым лимфобластным лейкозом. ПТЦф достоверно лучше предотвращал развитие острой РТПХ II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) и III-IV степени (HR 0.192, 95% CI 0.055-0.666, p=0.009), а также снижал вероятность рецидива (HR 0.519, 95% CI 0.297-0.893, p=0.023). Частота хронической РТПХ (HR 0.898, 95% CI 0.477-1.69, p=0.74) и трансплантационной летальности (HR 0.384, 95% CI 0.089-1.437, p=0.1768) достоверно не различались между группами. В группе пациентов с моноПТЦф наблюдалась достоверно более высокая общая выживаемость (HR 0.489, 95% CI 0.261-0.917, p=0.03), бессобытийная выживаемость (HR 0.571, 95% CI 0.334-0.976, p=0.04) и выживаемость без рецидива и РТПХ (HR 0.493, 95% CI 0.309-0.786, p=0.003). Токсичность ТКМ была сравнима в двух группах, за исключения меньшей нефротоксичности (33% против 43%, p=0.008) и частоты пост-трансплантационной микроангиопатии (3% против 11%, p=0.04) режима с ПТЦф, и большей частотой мукозитов 3-4 степени при данном режиме (41% против 34%, p=0.02). Несмотря на недостатки ретроспективного и одноцентрового подхода, в данном исследовании было показано преимущество режима профилактики РТПХ на основе моноПТЦф. Полученные результаты должны быть подтверждены в проспективном рандомизированном исследовании.
</p>
<h2 style="text-align: justify;">Ключевые слова</h2>
<p style="text-align: justify;">
	 Трансплантация костного мозга, реакция «трансплантат против хозяина», пост-трансплантационный циклофосфан, профилактика.
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	 В настоящий момент опубликован ряд исследований, показавших эффективность профилактики реакции «трансплантат против хозяина» (РТПХ) с использованием пост-трансплантационного циклофосфана в качестве единственного препарата (моноПТЦф) при HLA-совместимых трансплантациях костного мозга (ТКМ). Тем не менее, до сих пор не было опубликовано прямых сравнений эффективности моноПТЦф и классической профилактики с использованием ингибиторов кальциневрина (ИКН). В данном исследовании проведено сравнение результатов ТКМ у 78 пациентов, получавших профилактику РТПХ с использованием моноПТЦф, и 105 пациентов исторического контроля, получавших профилактику такролимусом/циклоспорином А и микофенолатом мофетилом/метотрексатом. Исследуемые группы были сравнимы по клиническим характеристикам, однако в группе с ИКН было больше пациентов группы «спасения» и больший процент пациентов с острым лимфобластным лейкозом. ПТЦф достоверно лучше предотвращал развитие острой РТПХ II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) и III-IV степени (HR 0.192, 95% CI 0.055-0.666, p=0.009), а также снижал вероятность рецидива (HR 0.519, 95% CI 0.297-0.893, p=0.023). Частота хронической РТПХ (HR 0.898, 95% CI 0.477-1.69, p=0.74) и трансплантационной летальности (HR 0.384, 95% CI 0.089-1.437, p=0.1768) достоверно не различались между группами. В группе пациентов с моноПТЦф наблюдалась достоверно более высокая общая выживаемость (HR 0.489, 95% CI 0.261-0.917, p=0.03), бессобытийная выживаемость (HR 0.571, 95% CI 0.334-0.976, p=0.04) и выживаемость без рецидива и РТПХ (HR 0.493, 95% CI 0.309-0.786, p=0.003). Токсичность ТКМ была сравнима в двух группах, за исключения меньшей нефротоксичности (33% против 43%, p=0.008) и частоты пост-трансплантационной микроангиопатии (3% против 11%, p=0.04) режима с ПТЦф, и большей частотой мукозитов 3-4 степени при данном режиме (41% против 34%, p=0.02). Несмотря на недостатки ретроспективного и одноцентрового подхода, в данном исследовании было показано преимущество режима профилактики РТПХ на основе моноПТЦф. Полученные результаты должны быть подтверждены в проспективном рандомизированном исследовании.

Ключевые слова

	 Трансплантация костного мозга, реакция «трансплантат против хозяина», пост-трансплантационный циклофосфан, профилактика.

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	 A number of studies were published demonstrating efficacy of single-agent graft-versus-host disease prophylaxis (GVHD) with post-transplantation cyclophosphamide (saPTCy) in matched related bone marrow transplantations (BMT), however no comparisons were published so far between saPTCy and conventional GVHD prophylaxis based on calcineurin inhibitors (CNIs). In this study, 78 patients graft ed with bone marrow from matched related donor (MRD) with saPTCy GVHD prophylaxis were compared to 105 historical control patients also receiving bone marrow from MRD, but with tacrolimus/cyclosporine A and mycophenolate mofetil/methotrexate prophylaxis. Groups were comparable in pre-transplant characteristics of patients, except higher prevalence of salvage patients and acute lymphoblastic leukemia in CNIs cohort. PTCy was superior to CNIs in prevention of grade II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) and grade III-IV acute GVHD (HR 0.192, 95% CI 0.055-0.666, p=0.009), relapse (HR 0.519, 95% CI 0.297-0.893, p=0.023). No difference was observed for moderate and severe chronic GVHD (HR 0.898, 95% CI 0.477-1.69, p=0.74) and non-relapse mortality (HR 0.384, 95% CI 0.089-1.437, p=0.1768). Patients after saPTCy had improved overall survival (HR 0.489, 95% CI 0.261-0.917, p=0.03), event-free-survival (HR 0.571, 95% CI 0.334-0.976, p=0.04) and GVHD-relapse-free survival (HR 0.493, 95% CI 0.309-0.786, p=0.003). Th e toxicity of BMT was generally comparable, except lower incidence of nephrotoxicity (33% vs 43%, p=0.008) aft er PTCy, but with higher incidence of grade 3-4 mucositis in this group (41% vs 34%, p=0.02). Despite limitations of single-center retrospective design, this study demonstrated superiority of saPTCy vs CNI-based prophylaxis, but these results should be confirmed in prospective randomized trials.
</p>
<h2 style="text-align: justify;">Keywords</h2>
<p style="text-align: justify;">
	 Bone marrow transplantation, graft-versus-host disease, post-transplantation cyclophosphamide, prophylaxis.
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	 A number of studies were published demonstrating efficacy of single-agent graft-versus-host disease prophylaxis (GVHD) with post-transplantation cyclophosphamide (saPTCy) in matched related bone marrow transplantations (BMT), however no comparisons were published so far between saPTCy and conventional GVHD prophylaxis based on calcineurin inhibitors (CNIs). In this study, 78 patients graft ed with bone marrow from matched related donor (MRD) with saPTCy GVHD prophylaxis were compared to 105 historical control patients also receiving bone marrow from MRD, but with tacrolimus/cyclosporine A and mycophenolate mofetil/methotrexate prophylaxis. Groups were comparable in pre-transplant characteristics of patients, except higher prevalence of salvage patients and acute lymphoblastic leukemia in CNIs cohort. PTCy was superior to CNIs in prevention of grade II-IV (HR 0.239, 95% CI 0.099-0.58, p=0.002) and grade III-IV acute GVHD (HR 0.192, 95% CI 0.055-0.666, p=0.009), relapse (HR 0.519, 95% CI 0.297-0.893, p=0.023). No difference was observed for moderate and severe chronic GVHD (HR 0.898, 95% CI 0.477-1.69, p=0.74) and non-relapse mortality (HR 0.384, 95% CI 0.089-1.437, p=0.1768). Patients after saPTCy had improved overall survival (HR 0.489, 95% CI 0.261-0.917, p=0.03), event-free-survival (HR 0.571, 95% CI 0.334-0.976, p=0.04) and GVHD-relapse-free survival (HR 0.493, 95% CI 0.309-0.786, p=0.003). Th e toxicity of BMT was generally comparable, except lower incidence of nephrotoxicity (33% vs 43%, p=0.008) aft er PTCy, but with higher incidence of grade 3-4 mucositis in this group (41% vs 34%, p=0.02). Despite limitations of single-center retrospective design, this study demonstrated superiority of saPTCy vs CNI-based prophylaxis, but these results should be confirmed in prospective randomized trials.

Keywords

	 Bone marrow transplantation, graft-versus-host disease, post-transplantation cyclophosphamide, prophylaxis.

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