Gilteritinib or chemotherapy for relapsed or refractory FLT3-mutated AML: New England Journal of Medicine

AE Perl, G Martinelli, JE Cortes, A Neubauer, E Berman, S Paolini, P Montesinos, MR Baer, RA Larson, C Ustun, F Fabbiano, HP Erba, A Di Stasi, R Stuart, R Olin, M Kasner, F Ciceri, WC Chou, N Podoltsev, C RecherH Yokoyama, N Hosono, SS Yoon, JH Lee, T Pardee, AT Fathi, C Liu, N Hasabou, X Liu, E Bahceci, MJ Levis

Research output: Contribution to journalArticle

Abstract

BACKGROUND Patients with relapsed or refractory acute myeloid leukemia (AML) with mutations in the FMS-like tyrosine kinase 3 gene (FLT3) infrequently have a response to salvage chemotherapy. Gilteritinib is an oral, potent, selective FLT3 inhibitor with single-agent activity in relapsed or refractory FLT3-mutated AML. METHODS In a phase 3 trial, we randomly assigned adults with relapsed or refractory FLT3mutated AML in a 2:1 ratio to receive either gilteritinib (at a dose of 120 mg per day) or salvage chemotherapy. The two primary end points were overall survival and the percentage of patients who had complete remission with full or partial hematologic recovery. Secondary end points included event-free survival (freedom from treatment failure [i.e., relapse or lack of remission] or death) and the percentage of patients who had complete remission. RESULTS Of 371 eligible patients, 247 were randomly assigned to the gilteritinib group and 124 to the salvage chemotherapy group. The median overall survival in the gilteritinib group was significantly longer than that in the chemotherapy group (9.3 months vs. 5.6 months; hazard ratio for death, 0.64; 95% confidence interval [CI], 0.49 to 0.83; P
Original languageEnglish
Pages (from-to)1728-1740
Number of pages13
JournalNew Engl. J. Med.
Volume381
Issue number18
DOIs
Publication statusPublished - 2019

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    Perl, AE., Martinelli, G., Cortes, JE., Neubauer, A., Berman, E., Paolini, S., Montesinos, P., Baer, MR., Larson, RA., Ustun, C., Fabbiano, F., Erba, HP., Di Stasi, A., Stuart, R., Olin, R., Kasner, M., Ciceri, F., Chou, WC., Podoltsev, N., ... Levis, MJ. (2019). Gilteritinib or chemotherapy for relapsed or refractory FLT3-mutated AML: New England Journal of Medicine. New Engl. J. Med., 381(18), 1728-1740. https://doi.org/10.1056/NEJMoa1902688