Allogeneic hematopoietic stem cell transplantation at the first remission for younger adults withFLT3-internal tandem duplication AML: The JALSG AML209-FLT3-SCT study
Open Access
- 1 July 2020
- journal article
- research article
- Published by Wiley in Cancer Science
- Vol. 111 (7), 2472-2481
- https://doi.org/10.1111/cas.14448
Abstract
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) forFLT3-internal tandem duplication (ITD)-positive AML. Newly diagnosed de novo AML patients withFLT3-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). NeitherFLT3-ITD AR nor cooccurring genetic alterations was associated with a poor DFS. This prospective study indicated the efficacy and safety of allo-HSCT forFLT3-ITD AML patients in CR1. This study was registered at: as #UMIN000003433.Keywords
Funding Information
- Japan Agency for Medical Research and Development (19ck0106251)
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