Changes in Outcomes of Allogeneic Hematopoietic Stem Cell Transplantation for FLT3-ITD-mutated Acute Myeloid Leukemia in the FLT3 Inhibitor Era.
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BACKGROUND: FLT3 mutations in acute myeloid leukemia (AML) are associated with high relapse rates even after allogeneic hematopoietic stem cell transplantation (allo-HSCT). OBJECTIVES: We evaluated changes in transplant outcomes in patients with FLT3-ITD-mutated AML and detailed real-world experiences with post-transplant gilteritinib maintenance. STUDY DESIGN: This study included adult patients (≥16 years) with FLT3-ITD-mutated AML who were eligible for allo-HSCT. The patients were stratified into the FLT3i era (2019-2024) and the pre-FLT3i era (2012-2018). The primary endpoint was the 3-year overall survival (OS). RESULTS: Ninety-three patients were included, 43 in the pre-FLT3i era and 50 in the FLT3i era. The FLT3i era was associated with a significantly higher 3-year OS from diagnosis (65.7% vs. 44.3%; 95% CI, 48.0-78.6 vs. 28.9-58.6). Thirty-eight patients and 48 patients, respectively, underwent allo-HSCT. The 3-year OS from allo-HSCT was 47.4% (95% CI, 31.0-62.1) and 60.6% (95% CI, 41.8-75.0), respectively (P = .11). Multivariate analysis revealed that myelodysplastic change, non-CR disease status at allo-HSCT, and a higher HCT-CI (≥2) were adverse prognostic factors. In the FLT3i era, 6 patients received maintenance therapy with gilteritinib. The median interval from HSCT to the initiation of gilteritinib was 30 days (range, 18-69). Five patients remained relapse-free, with a median treatment duration of 583 days. The 2-year OS rate was 83.3% (95% CI, 27.3-97.5). CONCLUSIONS: Although the OS from diagnosis improved significantly in the FLT3i era, relapse after allo-HSCT remained a substantial challenge. Further studies are needed to optimize FLT3i maintenance therapy strategies.