BORTEZOMIB IN COMBINATION WITH HIGH DOSE MELPHALAN AS CONDITIONING REGIMEN IS SAFE AND IMPROVES THE RESPONSE RATES IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA.
(Abstract release date: 05/19/16)
EHA Library. Dalla Palma A. 06/09/16; 134866; PB1966
Prof. Anna Benedetta Dalla Palma
Contributions
Contributions
Abstract
Abstract: PB1966
Type: Publication Only
Background
High dose therapy followed by autologous stem cell transplantation (ASCT) is the standard of care as first-line treatment in eligible patients with newly diagnosed Multiple Myeloma (MM). High-dose Melphalan (HDM) is the standard conditioning regimen before ASCT. Recent evidence suggests that the depth of response after the induction therapy influences the progression free survival (PFS) and, in most studies, the overall survival (OS). To improve the depth of response after ASCT in transplant–eligible MM patients the introduction of Bortezomib (BOR) to high-dose Melphalan (HDM) in conditioning regimen has shown to be effective without increased hematological toxicity.
Aims
Aim of the study is to evaluate safety and response rates in patients treated with BOR+HDM as conditioning regimen before ASCT.
Methods
In this study we retrospectively analyzed, in a single center, 27 patients treated with BOR-HDM as conditioning regimen as compared to a historical cohort of 21 patients treated with HDM alone in order to evaluate the safety and the response rate of the combination treatment. All patients in both groups were treated with novel agents as part of induction therapy. The conditioning regimen consisted in HDM (100-200 mg/m2, depending on age and comorbidity) administered on day -2, and only for patients in the BOR-HDM group, a single-dose Bortezomib at the dosage of 1.3 mg/m2 on day -1. Stem cells were reinfused on day 0.
Results
Any significant difference was not observed between the two cohorts of MM patients analyzed regarding the median age at diagnosis (61 vs 59 years) and the dose of Melphalan. Distribution of ISS stage was similar in the two groups, as well as that of high-risk cytogenetic or ultra high-risk features (ISS III plus high-risk cytogenetic). Moreover the response rates after the induction therapy was not statistically different in the two groups of patients analyzed.Any significant difference on hematopoietic recovery rates was not observed in BOR+HDM as compared to HDM alone, with a mean time to neutrophil recovery of 12 days (range 9-18) and to platelet recovery of 13 days (range 10-28) in both groups. BOR+HDM conditioning was well tolerated, with no increase of neuropathy occurrence. We then analyzed the response rate after ASCT, showing that the overall response rate was significantly higher in BOR-HDM group as compared to HDM (P=0.028) with a higher number of complete response (CR) (54% vs 17%). The number of stringent CR was also significantly higher in BOR-HDM as compared to HDM alone (3 vs 0).
Conclusion
In conclusion, this retrospective analysis suggests that BOR-HDM is safe as conditioning regimen with a higher response rate after ABMT in comparison to the standard HDM regimen, giving the rational design for randomized studies needed to assess whether this conditioning regimen is superior to HDM alone.
Session topic: E-poster
Keyword(s): Autologous hematopoietic stem cell transplantation, Bortezomib, Multiple myeloma
Type: Publication Only
Background
High dose therapy followed by autologous stem cell transplantation (ASCT) is the standard of care as first-line treatment in eligible patients with newly diagnosed Multiple Myeloma (MM). High-dose Melphalan (HDM) is the standard conditioning regimen before ASCT. Recent evidence suggests that the depth of response after the induction therapy influences the progression free survival (PFS) and, in most studies, the overall survival (OS). To improve the depth of response after ASCT in transplant–eligible MM patients the introduction of Bortezomib (BOR) to high-dose Melphalan (HDM) in conditioning regimen has shown to be effective without increased hematological toxicity.
Aims
Aim of the study is to evaluate safety and response rates in patients treated with BOR+HDM as conditioning regimen before ASCT.
Methods
In this study we retrospectively analyzed, in a single center, 27 patients treated with BOR-HDM as conditioning regimen as compared to a historical cohort of 21 patients treated with HDM alone in order to evaluate the safety and the response rate of the combination treatment. All patients in both groups were treated with novel agents as part of induction therapy. The conditioning regimen consisted in HDM (100-200 mg/m2, depending on age and comorbidity) administered on day -2, and only for patients in the BOR-HDM group, a single-dose Bortezomib at the dosage of 1.3 mg/m2 on day -1. Stem cells were reinfused on day 0.
Results
Any significant difference was not observed between the two cohorts of MM patients analyzed regarding the median age at diagnosis (61 vs 59 years) and the dose of Melphalan. Distribution of ISS stage was similar in the two groups, as well as that of high-risk cytogenetic or ultra high-risk features (ISS III plus high-risk cytogenetic). Moreover the response rates after the induction therapy was not statistically different in the two groups of patients analyzed.Any significant difference on hematopoietic recovery rates was not observed in BOR+HDM as compared to HDM alone, with a mean time to neutrophil recovery of 12 days (range 9-18) and to platelet recovery of 13 days (range 10-28) in both groups. BOR+HDM conditioning was well tolerated, with no increase of neuropathy occurrence. We then analyzed the response rate after ASCT, showing that the overall response rate was significantly higher in BOR-HDM group as compared to HDM (P=0.028) with a higher number of complete response (CR) (54% vs 17%). The number of stringent CR was also significantly higher in BOR-HDM as compared to HDM alone (3 vs 0).
Conclusion
In conclusion, this retrospective analysis suggests that BOR-HDM is safe as conditioning regimen with a higher response rate after ABMT in comparison to the standard HDM regimen, giving the rational design for randomized studies needed to assess whether this conditioning regimen is superior to HDM alone.
Session topic: E-poster
Keyword(s): Autologous hematopoietic stem cell transplantation, Bortezomib, Multiple myeloma
Abstract: PB1966
Type: Publication Only
Background
High dose therapy followed by autologous stem cell transplantation (ASCT) is the standard of care as first-line treatment in eligible patients with newly diagnosed Multiple Myeloma (MM). High-dose Melphalan (HDM) is the standard conditioning regimen before ASCT. Recent evidence suggests that the depth of response after the induction therapy influences the progression free survival (PFS) and, in most studies, the overall survival (OS). To improve the depth of response after ASCT in transplant–eligible MM patients the introduction of Bortezomib (BOR) to high-dose Melphalan (HDM) in conditioning regimen has shown to be effective without increased hematological toxicity.
Aims
Aim of the study is to evaluate safety and response rates in patients treated with BOR+HDM as conditioning regimen before ASCT.
Methods
In this study we retrospectively analyzed, in a single center, 27 patients treated with BOR-HDM as conditioning regimen as compared to a historical cohort of 21 patients treated with HDM alone in order to evaluate the safety and the response rate of the combination treatment. All patients in both groups were treated with novel agents as part of induction therapy. The conditioning regimen consisted in HDM (100-200 mg/m2, depending on age and comorbidity) administered on day -2, and only for patients in the BOR-HDM group, a single-dose Bortezomib at the dosage of 1.3 mg/m2 on day -1. Stem cells were reinfused on day 0.
Results
Any significant difference was not observed between the two cohorts of MM patients analyzed regarding the median age at diagnosis (61 vs 59 years) and the dose of Melphalan. Distribution of ISS stage was similar in the two groups, as well as that of high-risk cytogenetic or ultra high-risk features (ISS III plus high-risk cytogenetic). Moreover the response rates after the induction therapy was not statistically different in the two groups of patients analyzed.Any significant difference on hematopoietic recovery rates was not observed in BOR+HDM as compared to HDM alone, with a mean time to neutrophil recovery of 12 days (range 9-18) and to platelet recovery of 13 days (range 10-28) in both groups. BOR+HDM conditioning was well tolerated, with no increase of neuropathy occurrence. We then analyzed the response rate after ASCT, showing that the overall response rate was significantly higher in BOR-HDM group as compared to HDM (P=0.028) with a higher number of complete response (CR) (54% vs 17%). The number of stringent CR was also significantly higher in BOR-HDM as compared to HDM alone (3 vs 0).
Conclusion
In conclusion, this retrospective analysis suggests that BOR-HDM is safe as conditioning regimen with a higher response rate after ABMT in comparison to the standard HDM regimen, giving the rational design for randomized studies needed to assess whether this conditioning regimen is superior to HDM alone.
Session topic: E-poster
Keyword(s): Autologous hematopoietic stem cell transplantation, Bortezomib, Multiple myeloma
Type: Publication Only
Background
High dose therapy followed by autologous stem cell transplantation (ASCT) is the standard of care as first-line treatment in eligible patients with newly diagnosed Multiple Myeloma (MM). High-dose Melphalan (HDM) is the standard conditioning regimen before ASCT. Recent evidence suggests that the depth of response after the induction therapy influences the progression free survival (PFS) and, in most studies, the overall survival (OS). To improve the depth of response after ASCT in transplant–eligible MM patients the introduction of Bortezomib (BOR) to high-dose Melphalan (HDM) in conditioning regimen has shown to be effective without increased hematological toxicity.
Aims
Aim of the study is to evaluate safety and response rates in patients treated with BOR+HDM as conditioning regimen before ASCT.
Methods
In this study we retrospectively analyzed, in a single center, 27 patients treated with BOR-HDM as conditioning regimen as compared to a historical cohort of 21 patients treated with HDM alone in order to evaluate the safety and the response rate of the combination treatment. All patients in both groups were treated with novel agents as part of induction therapy. The conditioning regimen consisted in HDM (100-200 mg/m2, depending on age and comorbidity) administered on day -2, and only for patients in the BOR-HDM group, a single-dose Bortezomib at the dosage of 1.3 mg/m2 on day -1. Stem cells were reinfused on day 0.
Results
Any significant difference was not observed between the two cohorts of MM patients analyzed regarding the median age at diagnosis (61 vs 59 years) and the dose of Melphalan. Distribution of ISS stage was similar in the two groups, as well as that of high-risk cytogenetic or ultra high-risk features (ISS III plus high-risk cytogenetic). Moreover the response rates after the induction therapy was not statistically different in the two groups of patients analyzed.Any significant difference on hematopoietic recovery rates was not observed in BOR+HDM as compared to HDM alone, with a mean time to neutrophil recovery of 12 days (range 9-18) and to platelet recovery of 13 days (range 10-28) in both groups. BOR+HDM conditioning was well tolerated, with no increase of neuropathy occurrence. We then analyzed the response rate after ASCT, showing that the overall response rate was significantly higher in BOR-HDM group as compared to HDM (P=0.028) with a higher number of complete response (CR) (54% vs 17%). The number of stringent CR was also significantly higher in BOR-HDM as compared to HDM alone (3 vs 0).
Conclusion
In conclusion, this retrospective analysis suggests that BOR-HDM is safe as conditioning regimen with a higher response rate after ABMT in comparison to the standard HDM regimen, giving the rational design for randomized studies needed to assess whether this conditioning regimen is superior to HDM alone.
Session topic: E-poster
Keyword(s): Autologous hematopoietic stem cell transplantation, Bortezomib, Multiple myeloma
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