Allogeneic hematopoietic stem cell transplantation at the first remission for younger adults with FLT3-internal tandem duplication AML: The JALSG AML209-FLT3-SCT study.
Adolescent
Adult
Combined Modality Therapy
DNA Repeat Expansion
Female
Hematopoietic Stem Cell Transplantation
/ adverse effects
Humans
Kaplan-Meier Estimate
Leukemia, Myeloid, Acute
/ diagnosis
Male
Middle Aged
Prognosis
Remission Induction
Transplantation, Homologous
Treatment Outcome
Young Adult
fms-Like Tyrosine Kinase 3
/ genetics
FLT3-ITD
acute myeloid leukemia
allogeneic hematopoietic stem cell transplantation
Journal
Cancer science
ISSN: 1349-7006
Titre abrégé: Cancer Sci
Pays: England
ID NLM: 101168776
Informations de publication
Date de publication:
Jul 2020
Jul 2020
Historique:
received:
27
01
2020
revised:
16
04
2020
accepted:
03
05
2020
pubmed:
12
5
2020
medline:
11
8
2020
entrez:
12
5
2020
Statut:
ppublish
Résumé
In this phase II multicenter study (JALSG AML209-FLT3-SCT), we aimed to prospectively elucidate the role of allogeneic hematopoietic stem cell transplantation (allo-HSCT) at first complete remission (CR1) for FLT3-internal tandem duplication (ITD)-positive AML. Newly diagnosed de novo AML patients with FLT3-ITD were enrolled at the achievement of CR1 and received allo-HSCT as soon as possible after the first consolidation therapy. Mutations of 57 genes in AML cells at diagnosis were also analyzed. Among 48 eligible patients with a median age of 38.5 (17-49) years, 36 (75%) received allo-HSCT at a median of 108 days after CR1. The median follow-up was 1726 days. The primary end-point, 3-year disease-free survival (DFS) based on an intent to treat analysis, was 43.8% (95% confidence interval [CI], 30%-57%), suggesting the efficacy of this treatment because the lower limit of the 95% CI exceeded the threshold response rate of 20%. The 3-year overall survival, post-transplant DFS, and non-relapse mortality rates were 54.2% (95% CI, 39%-67%), 58.3% (95% CI, 41%-72%), and 25.0% (95% CI, 12%-40%), respectively. The median ITD allelic ratio (AR) was 0.344 (0.006-4.099). Neither FLT3-ITD AR nor cooccurring genetic alterations was associated with a poor DFS. This prospective study indicated the efficacy and safety of allo-HSCT for FLT3-ITD AML patients in CR1. This study was registered at: www.umin.ac.jp/ctr/ as #UMIN000003433.
Identifiants
pubmed: 32391628
doi: 10.1111/cas.14448
pmc: PMC7484840
doi:
Substances chimiques
FLT3 protein, human
EC 2.7.10.1
fms-Like Tyrosine Kinase 3
EC 2.7.10.1
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
2472-2481Subventions
Organisme : Japan Agency for Medical Research and Development
ID : 19ck0106251
Informations de copyright
© 2020 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.
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