ArticleCancer2025
Gilteritinib in FLT3-mutated acute myeloid leukemia: A real-world Italian experience.
Article in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Real-Life Study on Gilteritinib-Related Infections (GilteRInf): An Italian SEIFEM Study.American journal of hematology · 2026Article
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- Effectiveness of Gilteritinib Beyond Second-Line Therapy in Relapsed/Refractory FLT3 -Mutated Acute Myeloid Leukemia: A Real-World Multicenter Study of 171 Patients.American journal of hematology · 2026Article
- Targeting TLK2 with antisense oligonucleotides as a new strategy in acute myeloid leukemia.Frontiers in oncology · 2026Article
- Article
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Authors and funding
33 authors.
Funding
Abstract
BACKGROUND AND
methodsThis real-world study evaluated the clinical effectiveness of gilteritinib in 205 patients with relapsed or refractory (R/R) FLT3-mutated acute myeloid leukemia (AML) enrolled in the Italian expanded access since January 2018.
resultsOf the 205 patients, 124 (60.5%) received gilteritinib as a bridging therapy to allogeneic stem cell transplantation (allo-SCT), achieving complete remission in 52.4% (n = 65). The median overall survival (OS) for the entire cohort was 11.0 months, with estimated OS rates of 46.8% at 1 year and 28.5% at 3 years. Sixty patients (48% of those bridged) underwent allo-SCT after a median of 3.7 months on gilteritinib, achieving posttransplant OS rates of 65.2% at 1 year and 56.1% at 3 years. The acquisition of FLT3 mutations at relapse and the presence of TP53 co-mutations were significantly associated with inferior outcomes. Among 46 patients (22.4%) who relapsed after allo-SCT, gilteritinib treatment yielded an overall response rate (ORR) of 54.3%, a median OS of 11.1 months, and 1- and 3-year OS rates of 49.5% and 15.5%, respectively. Additionally, 35 patients (17.1%) previously treated with nonintensive chemotherapy received gilteritinib until disease progression or intolerance, achieving an ORR of 11.4%, a median OS of 5.9 months, and a 1-year OS rate of 29.0%.
conclusionsThese real-world data confirm that clinical outcomes achieved with gilteritinib in patients with R/R FLT3-mutated AML are consistent with those observed in pivotal clinical trials. Notably, approximately half of the transplant-eligible patients were successfully bridged to allo-SCT and demonstrated encouraging long-term survival.
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