Background: The addition of a FLT3 inhibitor (FLT3i) to standard chemotherapy to treat fit newly diagnosed (ND) patients with FLT3-mutated acute myeloid leukemia (AML) represents the standard of care resulting from clinical trial results. However, evidence regarding FLT3i adoption in routine clinical practice is still scarce. Methods: Clinical data are reported from 394 ND patients with FLT3-mutated AML enrolled in the retrospective observational Italian Cohort Study on FLT3-mutated patients with AML and treated with an upfront intensive regimen with (FLT3i group, n = 92) or without (CT group, n = 302) the addition of a FLT3i. Results: With a median follow-up time of 34.5 months, an effectiveness benefit obtained by FLT3i incorporation both in terms of overall survival (median, 34.9 in the FLT3i vs 12.7 months in the CT group, p < .01) and relapse-free survival (median, 18.9 in the FLT3i vs 7.6 months in the CT group, p = .01) was documented, with a higher composite complete remission rate (75.4% in the FLT3i vs 62.4% in the CT group, p = .052). FLT3i benefit seemed to be independent from the transplant rate. Conclusions: In conclusion, the benefit of FLT3i addition to upfront intensive treatment in newly diagnosed FLT3-mutated AML patients was confirmed in a large, real-life cohort study.
Upfront intensive treatment analysis of the Italian Cohort Study on FLT3‐mutated AML patients (FLAM): The impact of a FLT3 inhibitor addition to standard chemotherapy in the real‐life setting / Nanni, Jacopo; Azzali, Irene; Papayannidis, Cristina; Mulè, Antonino; Audisio, Ernesta; Martelli, Maria Paola; Scappini, Barbara; Chiusolo, Patrizia; Cambò, Benedetta; Candoni, Anna; Lunghi, Monia; Albano, Francesco; Olivieri, Attilio; Fracchiolla, Nicola; Bernardi, Massimo; Romani, Claudio; Rigolin, Gian Matteo; Giannini, Maria Benedetta; Bocchia, Monica; Todisco, Elisabetta; Cilloni, Daniela; Bochicchio, Maria Teresa; Ottaviani, Emanuela; Mattei, Agnese; Zamagni, Federica; Valli, Irene; Volpi, Roberta; Marconi, Giovanni; Petracci, Elisabetta; Null, Null; Martinelli, Giovanni. - In: CANCER. - ISSN 0008-543X. - 131:7(2025), pp. 1-10. [10.1002/cncr.35824]
Upfront intensive treatment analysis of the Italian Cohort Study on FLT3‐mutated AML patients (FLAM): The impact of a FLT3 inhibitor addition to standard chemotherapy in the real‐life setting
Candoni, Anna;
2025
Abstract
Background: The addition of a FLT3 inhibitor (FLT3i) to standard chemotherapy to treat fit newly diagnosed (ND) patients with FLT3-mutated acute myeloid leukemia (AML) represents the standard of care resulting from clinical trial results. However, evidence regarding FLT3i adoption in routine clinical practice is still scarce. Methods: Clinical data are reported from 394 ND patients with FLT3-mutated AML enrolled in the retrospective observational Italian Cohort Study on FLT3-mutated patients with AML and treated with an upfront intensive regimen with (FLT3i group, n = 92) or without (CT group, n = 302) the addition of a FLT3i. Results: With a median follow-up time of 34.5 months, an effectiveness benefit obtained by FLT3i incorporation both in terms of overall survival (median, 34.9 in the FLT3i vs 12.7 months in the CT group, p < .01) and relapse-free survival (median, 18.9 in the FLT3i vs 7.6 months in the CT group, p = .01) was documented, with a higher composite complete remission rate (75.4% in the FLT3i vs 62.4% in the CT group, p = .052). FLT3i benefit seemed to be independent from the transplant rate. Conclusions: In conclusion, the benefit of FLT3i addition to upfront intensive treatment in newly diagnosed FLT3-mutated AML patients was confirmed in a large, real-life cohort study.
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