Gilteritinib activity in refractory or relapsed FLT3-mutated acute myeloid leukemia patients previously treated by intensive chemotherapy and midostaurin: a study from the French AML Intergroup ALFA/FILO.
Fiche publication
Date publication
novembre 2022
Journal
Leukemia
Auteurs
Membres identifiés du Cancéropôle Est :
Dr CHRETIEN Marie-Lorraine
Tous les auteurs :
Dumas PY, Raffoux E, Bérard E, Bertoli S, Hospital MA, Heiblig M, Desbrosses Y, Bonmati C, Pautas C, Lambert J, Orvain C, Banos A, Pasquier F, Peterlin P, Marchand T, Uzunov M, Frayfer J, Turlure P, Cluzeau T, Jourdan E, Himberlin C, Tavernier E, Villate A, Haiat S, Chretien ML, Carre M, Chantepie S, Vaida I, Wemeau M, Chebrek S, Guillerm G, Guièze R, Debarri H, Gehlkopf E, Laribi K, Marcais A, Santagostino A, Béné MC, Mineur A, Pigneux A, Dombret H, Récher C
Lien Pubmed
Résumé
The real-world efficacy and safety of gilteritinib was assessed in an ambispective study that included 167 R/R FLT3-mutated AML patients. Among them, 140 received gilteritinib as single agent (cohort B), including 67 previously treated by intensive chemotherapy and midostaurin (cohort C). The main differences in patient characteristics in this study compared to the ADMIRAL trial were ECOG ≥ 2 (83.6% vs. 16.6%), FLT3-TKD mutation (21.0% vs. 8.5%), primary induction failure (15.0% vs. 40.0%) and line of treatment (beyond 2nd in 37.1% vs. 0.0%). The rates of composite complete remission, excluding those that occurred after hematopoietic stem cell transplantation (HSCT), were similar at respectively 25.4% and 27.5% in cohorts B and C. Median overall survival (OS) for these two groups was also similar at respectively 6.4 and 7.8 months. Multivariate analyses for prognostic factors associated with OS identified female gender (HR 1.61), adverse cytogenetic risk (HR 2.52), and allogenic HSCT after gilteritinib (HR 0.13). Although these patients were more heavily pretreated, these real-world data reproduce the results of ADMIRAL and provide new insights into the course of patients previously treated by intensive chemotherapy and midostaurin and beyond the 2nd line of treatment who can benefit from treatment in an outpatient setting.
Référence
Leukemia. 2022 11 14;: