Sampol, AntoniaGarcia, AntoniCervera, MartaGarcia Avila, SaraBargay, JoanOrtín, XavierNomdedéu Guinot, Josep FrancescEsteve, JordiSierra Gil, JorgeOñate, GuadalupePratcorona, MartaGarrido, AnaArtigas-Baleri, AliciaBataller Torralba, AlexTormo, MarArnan, MontserratVives, SusanaColl, RosaSalamero, OlgaVall Llovera, Ferran2025-11-272025-11-272023-05-052044-5385https://hdl.handle.net/2445/224473Midostaurin added to intensive chemotherapy is the standard of care for acute myeloid leukemia (AML) with FLT3 mutations (FLT3mut). We analyzed the impact of midostaurin in 227 FLT3mut-AML patients included in the AML-12 prospective trial for fit patients ≤70 years (#NCT04687098). Patients were divided into an early (2012-2015) and late (2016-2020) cohorts. They were uniformly treated except for the addition of midostaurin in 71% of late group patients. No differences were observed in response rates or the number of allotransplants between groups. Outcome was improved in the late period: 2-year relapse incidence decreased from 42% vs 29% in early vs late group (p = 0.024) and 2-year overall survival (OS) improved from 47% vs 61% (p = 0.042), respectively. The effect of midostaurin was evident in NPM1mut patients (n = 151), with 2-yr OS of 72% (exposed) vs 50% (naive) patients (p = 0.011) and mitigated FLT3-ITD allelic ratio prognostic value: 2-yr OS with midostaurin was 85% and 58% in low and high ratio patients (p = 0.049) vs 67% and 39% in naive patients (p = 0.005). In the wild-type NPM1 subset (n = 75), we did not observe significant differences between both study periods. In conclusion, this study highlights the improved outcome of FLT3mut AML fit patients with the incorporation of midostaurin.9 p.application/pdfengcc-by (c) Oñate, G. et al., 2023http://creativecommons.org/licenses/by/4.0/Pronòstic mèdicLeucèmia mieloideMutació (Biologia)PrognosisMyeloid leukemiaMutation (Biology)info:eu-repo/semantics/article7619552025-11-27info:eu-repo/semantics/openAccess37147301