Long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myeloma
Background: Most data on autologous hematopoietic cell transplantation (auto-HCT) in myeloma are based on the use of innovator formulation of melphalan. Comparative bioequivalence and efficacy studies of generic melphalan are lacking. Methods: In this retrospective study, we report long-term outcome...
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doaj-29205cbac8544135a500058ede439ade2021-05-22T04:36:20ZengElsevierHematology/Oncology and Stem Cell Therapy1658-38762021-06-01142114118Long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myelomaDeepesh P. Lad0Pankaj Malhotra1Amol N. Patil2Ram V. Nampoothiri3Kripa Shanker Kasudhan4Alka Khadwal5Gaurav Prakash6Arihant Jain7Samir Malhotra8Neelam Varma9Savita Verma Attri10Subhash Varma11Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India; Corresponding author at: Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh 160012, India.Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaDepartment of Clinical Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaDepartment of Clinical Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaDepartment of Clinical Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaDepartment of Hematology, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaDepartment of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaDepartment of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, IndiaBackground: Most data on autologous hematopoietic cell transplantation (auto-HCT) in myeloma are based on the use of innovator formulation of melphalan. Comparative bioequivalence and efficacy studies of generic melphalan are lacking. Methods: In this retrospective study, we report long-term outcomes of auto-HCT in myeloma using innovator (Alkeran, Aspen Pharma; n = 41) and generic melphalan (Alkacel, Celon Labs, India; n = 55) formulations. All consecutive patients at a single center from the period 2011–2018 were included. Results: The median follow-up in the innovator and generic groups was 61.7 and 32.5 months, respectively. Both groups were matched for age, sex, stage, and myeloma response. There were significantly more patients in the innovator melphalan group who were administered melphalan at a reduced dose at physician discretion (26.8% vs. 3.6%, p = .001). There were significantly more patients with grade 3 or higher mucositis (68.3% vs. 38.1%, p < .0001) and grade 3 or higher diarrhea (85.4% vs. 50.1%, p < .0001) in the innovator group. The median duration of hospital stay was significantly longer in the innovator group (19 days vs. 15.5 days, p < .0001). There were significantly more patients in the generic group who received standard maintenance (94.5% vs. 34.1%, p < .0001). Despite the differences in the melphalan dose and post-transplant strategies, the 4-year progression-free survival and overall survival were not significantly different in the two groups (58% vs. 63%, p = .7, 71% vs. 72%, p = .4, respectively). Conclusion: Long-term efficacy comparison is helpful in the absence of postmarketing bioequivalence studies of generic melphalan.http://www.sciencedirect.com/science/article/pii/S1658387620301138Auto-HCTGenericInnovatorMelphalanMyeloma |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Deepesh P. Lad Pankaj Malhotra Amol N. Patil Ram V. Nampoothiri Kripa Shanker Kasudhan Alka Khadwal Gaurav Prakash Arihant Jain Samir Malhotra Neelam Varma Savita Verma Attri Subhash Varma |
spellingShingle |
Deepesh P. Lad Pankaj Malhotra Amol N. Patil Ram V. Nampoothiri Kripa Shanker Kasudhan Alka Khadwal Gaurav Prakash Arihant Jain Samir Malhotra Neelam Varma Savita Verma Attri Subhash Varma Long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myeloma Hematology/Oncology and Stem Cell Therapy Auto-HCT Generic Innovator Melphalan Myeloma |
author_facet |
Deepesh P. Lad Pankaj Malhotra Amol N. Patil Ram V. Nampoothiri Kripa Shanker Kasudhan Alka Khadwal Gaurav Prakash Arihant Jain Samir Malhotra Neelam Varma Savita Verma Attri Subhash Varma |
author_sort |
Deepesh P. Lad |
title |
Long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myeloma |
title_short |
Long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myeloma |
title_full |
Long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myeloma |
title_fullStr |
Long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myeloma |
title_full_unstemmed |
Long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myeloma |
title_sort |
long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myeloma |
publisher |
Elsevier |
series |
Hematology/Oncology and Stem Cell Therapy |
issn |
1658-3876 |
publishDate |
2021-06-01 |
description |
Background: Most data on autologous hematopoietic cell transplantation (auto-HCT) in myeloma are based on the use of innovator formulation of melphalan. Comparative bioequivalence and efficacy studies of generic melphalan are lacking. Methods: In this retrospective study, we report long-term outcomes of auto-HCT in myeloma using innovator (Alkeran, Aspen Pharma; n = 41) and generic melphalan (Alkacel, Celon Labs, India; n = 55) formulations. All consecutive patients at a single center from the period 2011–2018 were included. Results: The median follow-up in the innovator and generic groups was 61.7 and 32.5 months, respectively. Both groups were matched for age, sex, stage, and myeloma response. There were significantly more patients in the innovator melphalan group who were administered melphalan at a reduced dose at physician discretion (26.8% vs. 3.6%, p = .001). There were significantly more patients with grade 3 or higher mucositis (68.3% vs. 38.1%, p < .0001) and grade 3 or higher diarrhea (85.4% vs. 50.1%, p < .0001) in the innovator group. The median duration of hospital stay was significantly longer in the innovator group (19 days vs. 15.5 days, p < .0001). There were significantly more patients in the generic group who received standard maintenance (94.5% vs. 34.1%, p < .0001). Despite the differences in the melphalan dose and post-transplant strategies, the 4-year progression-free survival and overall survival were not significantly different in the two groups (58% vs. 63%, p = .7, 71% vs. 72%, p = .4, respectively). Conclusion: Long-term efficacy comparison is helpful in the absence of postmarketing bioequivalence studies of generic melphalan. |
topic |
Auto-HCT Generic Innovator Melphalan Myeloma |
url |
http://www.sciencedirect.com/science/article/pii/S1658387620301138 |
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