FEASIBILITY AND SAFETY OF BENDAMUSTINE, ETOPOSIDE, CYTARABINE, MELPHALAN (BEEAM) CONDITIONING REGIMEN BEFORE AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT) IN 33 PATIENTS WITH MALIGNANT LYMPHOMA
(Abstract release date: 05/19/16)
EHA Library. Bedoui M. 06/09/16; 135073; PB2173
Dr. Manel Bedoui
Contributions
Contributions
Abstract
Abstract: PB2173
Type: Publication Only
Background
High-Dose Chemotherapy supported by Autologous Stem Cell Transplantation (HDC/ASCT) is considered the treatment of choice for relapsed/refractory or high risk malignant lymphoma. However, several questions on efficacy and feasibility of HDC/ASCT remain, such as the best candidates for this strategy, the optimal conditioning regimen, and acute and late effects.To date, few comparative randomized trials have been performed, and no regimen has demonstrated superiority to another. The commonly used conditioning regimens is BEAM (BICNU …). To overcome the sourcing out of Carmustine in France we have decided to replace this product with Bendamustine, demonstrated significantly superior efficacy compared with standard therapy in B cell lymphoma, and this based on the work published by Visani and al in 2011.
Aims
We report our experience in a retrospective study concerning 33 patients treated with this conditioning regimen
Methods
From July 2012 to February 2016, 33 patients with median age 56 (28 -70) years, 8 had more than 65 years, Sex ratio (M/F) 22/11, underwent this procedure. This regimen BeEAM combined Bendamustine 100 mg/m² d-7 to d-6; Etoposide 200 mg/m² d-5 to d-2; Cytarabine 200 mg/m² twice daily d-5 to d-3; Melphalan 140 mg/m² d-1 and the reinjection of hematopoietic stem cell was done at d0. We did a reduction of 30% of Cytarabine and Etoposide doses because of age (6 patients). The diagnosis was NHL in 30 cases, composite hemopathy in 2 cases, and HD in 1 case. 30 patients had advanced stage disease (III-IV) of Ann Arbor classification, and a Bulky disease in 4 cases. For 10 patients with DLBCL in first line treatment, the IPIaa was > 2 in all cases. 15 patients received intensification followed by ASCT in first line treatment, 12 in relapse disease and 6 were primary refractory. The median number of previous line therapy was 2 (1-4). The status at the time of ASCT was evaluated by PET/CT in 29 cases. 23 were in complete remission (CR) and 6 in partial remission (PR). 4 patients was evaluated only by CT-scan (3 PR, 1 CR).
Results
Among the 33 patients treated, the number of autologous CD34+ cells infused was systematically > to 2x10^6 CD34+/kg, and we observed that the median time to myeloid engraftment (ANC>0.5x10^9/l) was 8 days (4-16), and the median time to platelet engraftment (>20x10^9/l) was 15 days (6-39). The digestive toxicity was important with 16 patients who present a diarrhea grade III-IV, and 23 oral mucositis grade III-IV. One patient presented a veno occlusive disease (VOD) treated with Defibrotide®. We observed 3 cases of cardiac toxicity (3 heart failure grade III partially reversible with medical treatment), 5 renal failure grade I-II.One patient died due to a septic choc with multidrug resistant bacteria before hematological recovery after transplant, producing an overall transplant related mortality (TRM) of 0.03%.2 patients died at distance of intensification by other causes (one patient with multiple infections caused by opportunistic agents, and the other one with secondary myeloid hemopathy) and the others 30 patients still alive, 29 in continuous CR.
Conclusion
The new effective regimen BeEAM is not safe in this population of patients with High Risk malignant non Hodgkin and Hodgkin lymphoma. The switch of Carmustine to Bendamustine in the intensive conditioning regimen, required a randomized trial to compare BeEAM and BEAM in new conditioning strategies, and advances in the supportive care will probably reduce transplantation related mortality (TRM).Limited data are available to optimize elderly patients selection for transplantation while minimizing the risk of TRM.
Session topic: E-poster
Type: Publication Only
Background
High-Dose Chemotherapy supported by Autologous Stem Cell Transplantation (HDC/ASCT) is considered the treatment of choice for relapsed/refractory or high risk malignant lymphoma. However, several questions on efficacy and feasibility of HDC/ASCT remain, such as the best candidates for this strategy, the optimal conditioning regimen, and acute and late effects.To date, few comparative randomized trials have been performed, and no regimen has demonstrated superiority to another. The commonly used conditioning regimens is BEAM (BICNU …). To overcome the sourcing out of Carmustine in France we have decided to replace this product with Bendamustine, demonstrated significantly superior efficacy compared with standard therapy in B cell lymphoma, and this based on the work published by Visani and al in 2011.
Aims
We report our experience in a retrospective study concerning 33 patients treated with this conditioning regimen
Methods
From July 2012 to February 2016, 33 patients with median age 56 (28 -70) years, 8 had more than 65 years, Sex ratio (M/F) 22/11, underwent this procedure. This regimen BeEAM combined Bendamustine 100 mg/m² d-7 to d-6; Etoposide 200 mg/m² d-5 to d-2; Cytarabine 200 mg/m² twice daily d-5 to d-3; Melphalan 140 mg/m² d-1 and the reinjection of hematopoietic stem cell was done at d0. We did a reduction of 30% of Cytarabine and Etoposide doses because of age (6 patients). The diagnosis was NHL in 30 cases, composite hemopathy in 2 cases, and HD in 1 case. 30 patients had advanced stage disease (III-IV) of Ann Arbor classification, and a Bulky disease in 4 cases. For 10 patients with DLBCL in first line treatment, the IPIaa was > 2 in all cases. 15 patients received intensification followed by ASCT in first line treatment, 12 in relapse disease and 6 were primary refractory. The median number of previous line therapy was 2 (1-4). The status at the time of ASCT was evaluated by PET/CT in 29 cases. 23 were in complete remission (CR) and 6 in partial remission (PR). 4 patients was evaluated only by CT-scan (3 PR, 1 CR).
Results
Among the 33 patients treated, the number of autologous CD34+ cells infused was systematically > to 2x10^6 CD34+/kg, and we observed that the median time to myeloid engraftment (ANC>0.5x10^9/l) was 8 days (4-16), and the median time to platelet engraftment (>20x10^9/l) was 15 days (6-39). The digestive toxicity was important with 16 patients who present a diarrhea grade III-IV, and 23 oral mucositis grade III-IV. One patient presented a veno occlusive disease (VOD) treated with Defibrotide®. We observed 3 cases of cardiac toxicity (3 heart failure grade III partially reversible with medical treatment), 5 renal failure grade I-II.One patient died due to a septic choc with multidrug resistant bacteria before hematological recovery after transplant, producing an overall transplant related mortality (TRM) of 0.03%.2 patients died at distance of intensification by other causes (one patient with multiple infections caused by opportunistic agents, and the other one with secondary myeloid hemopathy) and the others 30 patients still alive, 29 in continuous CR.
Conclusion
The new effective regimen BeEAM is not safe in this population of patients with High Risk malignant non Hodgkin and Hodgkin lymphoma. The switch of Carmustine to Bendamustine in the intensive conditioning regimen, required a randomized trial to compare BeEAM and BEAM in new conditioning strategies, and advances in the supportive care will probably reduce transplantation related mortality (TRM).Limited data are available to optimize elderly patients selection for transplantation while minimizing the risk of TRM.
Session topic: E-poster
Abstract: PB2173
Type: Publication Only
Background
High-Dose Chemotherapy supported by Autologous Stem Cell Transplantation (HDC/ASCT) is considered the treatment of choice for relapsed/refractory or high risk malignant lymphoma. However, several questions on efficacy and feasibility of HDC/ASCT remain, such as the best candidates for this strategy, the optimal conditioning regimen, and acute and late effects.To date, few comparative randomized trials have been performed, and no regimen has demonstrated superiority to another. The commonly used conditioning regimens is BEAM (BICNU …). To overcome the sourcing out of Carmustine in France we have decided to replace this product with Bendamustine, demonstrated significantly superior efficacy compared with standard therapy in B cell lymphoma, and this based on the work published by Visani and al in 2011.
Aims
We report our experience in a retrospective study concerning 33 patients treated with this conditioning regimen
Methods
From July 2012 to February 2016, 33 patients with median age 56 (28 -70) years, 8 had more than 65 years, Sex ratio (M/F) 22/11, underwent this procedure. This regimen BeEAM combined Bendamustine 100 mg/m² d-7 to d-6; Etoposide 200 mg/m² d-5 to d-2; Cytarabine 200 mg/m² twice daily d-5 to d-3; Melphalan 140 mg/m² d-1 and the reinjection of hematopoietic stem cell was done at d0. We did a reduction of 30% of Cytarabine and Etoposide doses because of age (6 patients). The diagnosis was NHL in 30 cases, composite hemopathy in 2 cases, and HD in 1 case. 30 patients had advanced stage disease (III-IV) of Ann Arbor classification, and a Bulky disease in 4 cases. For 10 patients with DLBCL in first line treatment, the IPIaa was > 2 in all cases. 15 patients received intensification followed by ASCT in first line treatment, 12 in relapse disease and 6 were primary refractory. The median number of previous line therapy was 2 (1-4). The status at the time of ASCT was evaluated by PET/CT in 29 cases. 23 were in complete remission (CR) and 6 in partial remission (PR). 4 patients was evaluated only by CT-scan (3 PR, 1 CR).
Results
Among the 33 patients treated, the number of autologous CD34+ cells infused was systematically > to 2x10^6 CD34+/kg, and we observed that the median time to myeloid engraftment (ANC>0.5x10^9/l) was 8 days (4-16), and the median time to platelet engraftment (>20x10^9/l) was 15 days (6-39). The digestive toxicity was important with 16 patients who present a diarrhea grade III-IV, and 23 oral mucositis grade III-IV. One patient presented a veno occlusive disease (VOD) treated with Defibrotide®. We observed 3 cases of cardiac toxicity (3 heart failure grade III partially reversible with medical treatment), 5 renal failure grade I-II.One patient died due to a septic choc with multidrug resistant bacteria before hematological recovery after transplant, producing an overall transplant related mortality (TRM) of 0.03%.2 patients died at distance of intensification by other causes (one patient with multiple infections caused by opportunistic agents, and the other one with secondary myeloid hemopathy) and the others 30 patients still alive, 29 in continuous CR.
Conclusion
The new effective regimen BeEAM is not safe in this population of patients with High Risk malignant non Hodgkin and Hodgkin lymphoma. The switch of Carmustine to Bendamustine in the intensive conditioning regimen, required a randomized trial to compare BeEAM and BEAM in new conditioning strategies, and advances in the supportive care will probably reduce transplantation related mortality (TRM).Limited data are available to optimize elderly patients selection for transplantation while minimizing the risk of TRM.
Session topic: E-poster
Type: Publication Only
Background
High-Dose Chemotherapy supported by Autologous Stem Cell Transplantation (HDC/ASCT) is considered the treatment of choice for relapsed/refractory or high risk malignant lymphoma. However, several questions on efficacy and feasibility of HDC/ASCT remain, such as the best candidates for this strategy, the optimal conditioning regimen, and acute and late effects.To date, few comparative randomized trials have been performed, and no regimen has demonstrated superiority to another. The commonly used conditioning regimens is BEAM (BICNU …). To overcome the sourcing out of Carmustine in France we have decided to replace this product with Bendamustine, demonstrated significantly superior efficacy compared with standard therapy in B cell lymphoma, and this based on the work published by Visani and al in 2011.
Aims
We report our experience in a retrospective study concerning 33 patients treated with this conditioning regimen
Methods
From July 2012 to February 2016, 33 patients with median age 56 (28 -70) years, 8 had more than 65 years, Sex ratio (M/F) 22/11, underwent this procedure. This regimen BeEAM combined Bendamustine 100 mg/m² d-7 to d-6; Etoposide 200 mg/m² d-5 to d-2; Cytarabine 200 mg/m² twice daily d-5 to d-3; Melphalan 140 mg/m² d-1 and the reinjection of hematopoietic stem cell was done at d0. We did a reduction of 30% of Cytarabine and Etoposide doses because of age (6 patients). The diagnosis was NHL in 30 cases, composite hemopathy in 2 cases, and HD in 1 case. 30 patients had advanced stage disease (III-IV) of Ann Arbor classification, and a Bulky disease in 4 cases. For 10 patients with DLBCL in first line treatment, the IPIaa was > 2 in all cases. 15 patients received intensification followed by ASCT in first line treatment, 12 in relapse disease and 6 were primary refractory. The median number of previous line therapy was 2 (1-4). The status at the time of ASCT was evaluated by PET/CT in 29 cases. 23 were in complete remission (CR) and 6 in partial remission (PR). 4 patients was evaluated only by CT-scan (3 PR, 1 CR).
Results
Among the 33 patients treated, the number of autologous CD34+ cells infused was systematically > to 2x10^6 CD34+/kg, and we observed that the median time to myeloid engraftment (ANC>0.5x10^9/l) was 8 days (4-16), and the median time to platelet engraftment (>20x10^9/l) was 15 days (6-39). The digestive toxicity was important with 16 patients who present a diarrhea grade III-IV, and 23 oral mucositis grade III-IV. One patient presented a veno occlusive disease (VOD) treated with Defibrotide®. We observed 3 cases of cardiac toxicity (3 heart failure grade III partially reversible with medical treatment), 5 renal failure grade I-II.One patient died due to a septic choc with multidrug resistant bacteria before hematological recovery after transplant, producing an overall transplant related mortality (TRM) of 0.03%.2 patients died at distance of intensification by other causes (one patient with multiple infections caused by opportunistic agents, and the other one with secondary myeloid hemopathy) and the others 30 patients still alive, 29 in continuous CR.
Conclusion
The new effective regimen BeEAM is not safe in this population of patients with High Risk malignant non Hodgkin and Hodgkin lymphoma. The switch of Carmustine to Bendamustine in the intensive conditioning regimen, required a randomized trial to compare BeEAM and BEAM in new conditioning strategies, and advances in the supportive care will probably reduce transplantation related mortality (TRM).Limited data are available to optimize elderly patients selection for transplantation while minimizing the risk of TRM.
Session topic: E-poster
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