Busulfan-fludarabine versus busulfan-cyclophosphamide for allogeneic transplant in acute myeloid leukemia: long term analysis of GITMO AML-R2 trial.
Humans
Busulfan
/ administration & dosage
Middle Aged
Leukemia, Myeloid, Acute
/ therapy
Adult
Vidarabine
/ analogs & derivatives
Cyclophosphamide
/ therapeutic use
Female
Male
Hematopoietic Stem Cell Transplantation
/ methods
Aged
Transplantation Conditioning
/ methods
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Transplantation, Homologous
Follow-Up Studies
Journal
Blood cancer journal
ISSN: 2044-5385
Titre abrégé: Blood Cancer J
Pays: United States
ID NLM: 101568469
Informations de publication
Date de publication:
21 Aug 2024
21 Aug 2024
Historique:
received:
17
06
2024
accepted:
26
07
2024
revised:
18
07
2024
medline:
22
8
2024
pubmed:
22
8
2024
entrez:
21
8
2024
Statut:
epublish
Résumé
We report the long-term results of a randomized trial (GITMO, AML-R2), comparing 1:1 the combination of busulfan and cyclophosphamide (BuCy2, n = 125) and the combination of busulfan and fludarabine (BuFlu, n = 127) as conditioning regimen in acute myeloid leukemia patients (median age 51 years, range 40-65) undergoing allogeneic hematopoietic stem cell transplantation. With a median follow-up of 6 years, significantly better non-relapse mortality (NRM) was confirmed in BuFlu recipients, which is sustained up to 4 years after transplant (10% vs. 20%, p = 0.0388). This difference was higher in patients older than 51 years (11% in BuFlu vs. 27% in BuCy2, p = 0.0262). The cumulative incidence of relapse, which was the first cause of death in the entire study population, did not differ between the two randomized arms. Similarly, the leukemia-free survival (LFS) and overall survival (OS) were not different in the two cohorts, even when stratifying patients per median age. Graft-and relapse-free survival (GRFS) in BuFlu arm vs. the BuCy2 arm was 25% vs. 20% at 4 years and 20% vs. 17% at 10 years. Hence, the benefit gained by NRM reduction is not offsets by an increased relapse. Leukemia relapse remains a major concern, urging the development of new therapeutic approaches.
Identifiants
pubmed: 39168989
doi: 10.1038/s41408-024-01116-5
pii: 10.1038/s41408-024-01116-5
doi:
Substances chimiques
Busulfan
G1LN9045DK
Vidarabine
FA2DM6879K
Cyclophosphamide
8N3DW7272P
fludarabine
P2K93U8740
Types de publication
Journal Article
Randomized Controlled Trial
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
141Informations de copyright
© 2024. The Author(s).
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