1. Gilteritinib with or without venetoclax for relapsed/refractory FLT3‐mutated acute myeloid leukaemia.
- Author
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Kugler, Eitan, Cohen, Inbar, Amitai, Irina, Ram, Ron, Frisch, Avraham, Nachmias, Boaz, Canaani, Jonathan, Moshe, Yakir, Krayem, Baher, Aumann, Shlomzion, Henig, Israel, Vainstein, Vladimir, Shargian, Liat, Ganzel, Chezi, Yeshurun, Moshe, Levi, Itay, Raanani, Pia, Akria, Luiza, Ofran, Yishai, and Shimony, Shai
- Subjects
ACUTE myeloid leukemia ,PROTEIN-tyrosine kinases ,VENETOCLAX ,OVERALL survival ,HEMATOPOIETIC stem cell transplantation - Abstract
Summary: Patients with FLT3‐mutated acute myeloid leukaemia (AML) that relapse or are refractory (R/R) to intensive induction have poor outcomes. Gilteritinib has recently become standard‐of‐care for patients with R/R FLT3‐mutated AML. We investigated whether adding venetoclax to gilteritinib (gilt‐ven) improves outcomes as compared with gilteritinib monotherapy. We included patients treated with gilteritinib (n = 19) and gilt‐ven (n = 17) for R/R AML after intensive chemotherapy. Gilteritinib and gilt‐ven groups did not differ in terms of mCRc rates (53% and 65%, p = 0.51) and realization of allogeneic haematopoietic stem‐cell transplantation (HSCT, 47% and 35%, p = 0.5). Overall survival (OS) was comparable between groups, although a trend towards better OS was seen with gilt‐ven (12‐month OS 58.8% [95% CI 39.5%–87.6%]) versus gilteritinib (42.1% [95% CI 24.9%–71.3%] for gilteritinib). Early salvage with gilt‐ven versus any other gilteritinib‐based approach was associated with the best outcome (p = 0.031). Combination therapy was associated with increased haematological toxicity. In summary, gilt‐ven did not improve remissions or HSCT‐realization rates in patients with R/R FLT3‐mutated AML as compared with gilteritinib and was associated with increased haematological toxicity. Although OS did not differ, a trend towards better survival was suggested with gilt‐ven and a survival benefit was shown for gilt‐ven approach when sequenced early for salvage. [ABSTRACT FROM AUTHOR]
- Published
- 2024
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