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Meta-Analysis
. 2025 Aug:155:107724.
doi: 10.1016/j.leukres.2025.107724. Epub 2025 Jun 2.

Impact of FLT3 inhibitors on the outcomes of FLT3-ITD mutated acute myeloid leukemia following allogeneic hematopoietic stem cell transplant: A systematic review and meta-analysis

Muhammad Kashif Amin  1 , Muhammad Atif Khan  2 , Faiza Humayun Khan  3 , Asma Zakir  2 , Muayad Azzam  2 , Reem Mustafa  2 , Talha Badar  4
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Free article
Meta-Analysis

Impact of FLT3 inhibitors on the outcomes of FLT3-ITD mutated acute myeloid leukemia following allogeneic hematopoietic stem cell transplant: A systematic review and meta-analysis

Muhammad Kashif Amin et al. Leuk Res. 2025 Aug.
Free article

Abstract

Background: Acute Myeloid Leukemia (AML) with FLT3-ITD mutations is associated with high post-transplant relapse rates. FLT3 inhibitor (FLT3i) maintenance therapy following allogeneic hematopoietic stem cell transplantation (allo-HCT) has emerged as a promising strategy to improve outcomes in this high-risk population.

Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) evaluating FLT3i maintenance therapy versus standard of care (SOC) after allo-HCT in patients with FLT3-ITD-mutated acute myeloid leukemia (AML). A comprehensive search of PubMed, Embase, CENTRAL, and ClinicalTrials.gov was performed in accordance with PRISMA guidelines. Primary outcomes included relapse-free survival (RFS), overall survival (OS), and FLT3i-related adverse events. Pooled hazard ratios (HRs) and relative risks (RRs) were calculated using the "meta" package in R (version 4.4.0).

Results: Four RCTs including 701 patients (ages 18-78) met inclusion criteria. FLT3i maintenance significantly reduced relapse (HR 0.50; 95 % CI: 0.34-0.74) and mortality (HR 0.63; 95 % CI: 0.44-0.91) compared to SOC. Hematologic toxicity (RR 2.12; 95 % CI: 1.67-2.70) and chronic GVHD (RR 1.18; 95 % CI: 1.00-1.41) were more frequent in the FLT3i group. Rates of acute GVHD (RR 1.05; 95 % CI: 0.78-1.41) and hepatotoxicity (RR 1.09; 95 % CI: 0.72-1.66) were comparable. Interestingly, skin toxicity was lower with FLT3i (RR 0.36; 95 % CI: 0.16-0.84).

Conclusion: FLT3i maintenance significantly improves RFS and OS in FLT3-ITD-mutated AML post-allo-HCT, though at the cost of increased hematologic toxicity and chronic GVHD. Further studies are needed to define optimal agents, duration, and patient selection to balance efficacy with tolerability.

Keywords: Acute myeloid leukemia (AML); FLT3 inhibitors; Post-transplant maintenance therapy.

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Conflict of interest statement

Declaration of Competing Interest The authors declare no conflicts of interest related to this study. The research was conducted independently, and no funding or sponsorship from commercial entities influenced the study design, data analysis, or manuscript preparation.

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