Long-term outcomes of innovator versus generic melphalan formulation in autologous hematopoietic cell transplantation for multiple myeloma.
Adult
Antineoplastic Agents, Alkylating
/ therapeutic use
Disease-Free Survival
Drug Substitution
Drugs, Generic
/ therapeutic use
Female
Hematopoietic Stem Cell Transplantation
/ methods
Humans
Male
Melphalan
/ therapeutic use
Middle Aged
Multiple Myeloma
/ therapy
Myeloablative Agonists
/ therapeutic use
Retrospective Studies
Transplantation, Autologous
/ methods
Treatment Outcome
Auto-HCT
Generic
Innovator
Melphalan
Myeloma
Journal
Hematology/oncology and stem cell therapy
ISSN: 2589-0646
Titre abrégé: Hematol Oncol Stem Cell Ther
Pays: Saudi Arabia
ID NLM: 101468532
Informations de publication
Date de publication:
Jun 2021
Jun 2021
Historique:
received:
14
05
2020
revised:
08
06
2020
accepted:
09
06
2020
pubmed:
6
7
2020
medline:
16
6
2021
entrez:
6
7
2020
Statut:
ppublish
Résumé
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. 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. 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). Long-term efficacy comparison is helpful in the absence of postmarketing bioequivalence studies of generic melphalan.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
Long-term efficacy comparison is helpful in the absence of postmarketing bioequivalence studies of generic melphalan.
Identifiants
pubmed: 32622756
pii: S1658-3876(20)30113-8
doi: 10.1016/j.hemonc.2020.06.002
pii:
doi:
Substances chimiques
Antineoplastic Agents, Alkylating
0
Drugs, Generic
0
Myeloablative Agonists
0
Melphalan
Q41OR9510P
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
114-118Informations de copyright
Copyright © 2020 King Faisal Specialist Hospital & Research Centre. Published by Elsevier Ltd. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest Part of this work was funded by the Science and Engineering Research Board, Department of Science and Technology, Government of India (file number ECR/2016/000884) grant to DPL and ANP. All the other authors have no competing financial interests to disclose.