BendaEAM versus BEAM as conditioning regimen for ASCT in patients with relapsed lymphoma (BEB): a multicentre, randomised, phase 2 trial.
Autologous stem cell transplantation
BEAM
Bendamustine
Conditioning regimen
Lymphoma
Journal
EClinicalMedicine
ISSN: 2589-5370
Titre abrégé: EClinicalMedicine
Pays: England
ID NLM: 101733727
Informations de publication
Date de publication:
Dec 2023
Dec 2023
Historique:
received:
22
05
2023
revised:
23
10
2023
accepted:
31
10
2023
medline:
29
11
2023
pubmed:
29
11
2023
entrez:
29
11
2023
Statut:
epublish
Résumé
Replacement of carmustine (BCNU) in the BEAM regimen (BCNU, etoposide, cytarabine, melphalan) with bendamustine (BendaEAM) before autologous stem cell transplantation (ASCT) is feasible in lymphoma. However, randomised trials are lacking. Here, we present the first trial addressing this topic. This multicentre, randomised, phase 2 study (BEB-trial) conducted at four haematological centres in Austria and Switzerland compares BEAM with BendaEAM in patients with relapsed lymphoma. Both regimens were administered intravenously before ASCT, in BEAM according to the standard protocol (300 mg/m Between April 20, 2015, and November 28, 2018, 108 patients were enrolled; of whom 53 were randomly assigned to receive BendaEAM (36 male, 17 female) and 55 to receive BEAM (39 male, 16 female). All patients engrafted rapidly. Lung toxicity did not differ between groups (BendaEAM: n = 8, 19.5%; BEAM: n = 11, 25.6%; risk difference = -6.1%: 95% confidence interval: -23.9% to 11.7%). Acute toxicities of at least grade 3 were comparable in both groups (BendaEAM: 35.8%, BEAM: 30.9%). Overall survival (BendaEAM: 92.5%, BEAM: 89.1%) and complete remission (BendaEAM: 76.7%, BEAM: 74.3%) after 1 year (median follow-up: 369 days) were similar. No difference in quality of life was observed. Results were similar for both regimens in terms of survival and response rates. A phase 3 non-inferiority study is required to investigate whether BendaEAM can be considered as an alternative to BEAM. Mundipharma.
Sections du résumé
Background
UNASSIGNED
Replacement of carmustine (BCNU) in the BEAM regimen (BCNU, etoposide, cytarabine, melphalan) with bendamustine (BendaEAM) before autologous stem cell transplantation (ASCT) is feasible in lymphoma. However, randomised trials are lacking. Here, we present the first trial addressing this topic.
Methods
UNASSIGNED
This multicentre, randomised, phase 2 study (BEB-trial) conducted at four haematological centres in Austria and Switzerland compares BEAM with BendaEAM in patients with relapsed lymphoma. Both regimens were administered intravenously before ASCT, in BEAM according to the standard protocol (300 mg/m
Findings
UNASSIGNED
Between April 20, 2015, and November 28, 2018, 108 patients were enrolled; of whom 53 were randomly assigned to receive BendaEAM (36 male, 17 female) and 55 to receive BEAM (39 male, 16 female). All patients engrafted rapidly. Lung toxicity did not differ between groups (BendaEAM: n = 8, 19.5%; BEAM: n = 11, 25.6%; risk difference = -6.1%: 95% confidence interval: -23.9% to 11.7%). Acute toxicities of at least grade 3 were comparable in both groups (BendaEAM: 35.8%, BEAM: 30.9%). Overall survival (BendaEAM: 92.5%, BEAM: 89.1%) and complete remission (BendaEAM: 76.7%, BEAM: 74.3%) after 1 year (median follow-up: 369 days) were similar. No difference in quality of life was observed.
Interpretation
UNASSIGNED
Results were similar for both regimens in terms of survival and response rates. A phase 3 non-inferiority study is required to investigate whether BendaEAM can be considered as an alternative to BEAM.
Funding
UNASSIGNED
Mundipharma.
Identifiants
pubmed: 38024477
doi: 10.1016/j.eclinm.2023.102318
pii: S2589-5370(23)00495-9
pmc: PMC10679477
doi:
Banques de données
ClinicalTrials.gov
['NCT02278796']
Types de publication
Journal Article
Langues
eng
Pagination
102318Informations de copyright
© 2023 Published by Elsevier Ltd.
Déclaration de conflit d'intérêts
FK received research funding from Mundipharma and honoraria from Novartis, Gilead, Janssen, Astra Zeneca, Abbvie, Roche, Takeda, BMS, and Incyte. VB-A received honoraria from AOP Orphan, Incyte, Novartis, Gilead, BMS Celgene, Amgen, Takeda, Sanofi, GSK, and Janssen-Cilag. TN received honoraria from Janssen and Roche. RG received honoraria from Celgene, Novartis, Roche, BMS, Takeda, Abbvie, Astra Zeneca, Janssen-Cilag, MSD, Merck, Gilead, Daiichi Sankyo, Sanofi Amgen, and Sandoz; and holds stock (options) from Novo Nordisk and Lilly. ABe received honoraria from Roche. All other authors declare no competing interests.
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