FLAMSA versus FLAG-IDA as salvage therapy in adults with relapsed/refractory acute myeloid leukemia and acute lymphoblastic leukemia: A single-center real-world retrospective study.
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Management of relapsed or refractory acute leukemia remains challenging, as allogeneic transplantation is the only curative option. Although targeted therapies are increasingly incorporated as bridge-to-transplant strategies in both AML and ALL, conventional chemotherapy regimens such as FLAMSA and FLAG-IDA remain important salvage options for patients without targetable molecular alterations or when access to targeted therapies is limited. There are no head-to-head comparative data for these two regimens. We retrospectively evaluated 102 adults with relapsed or refractory AML or ALL who were treated with FLAMSA or FLAG-IDA as salvage regimens between 2010 and 2023, including primary refractory patients and those relapsing after Allo-HCT. Among patients treated with the intent to transplant (n = 86), CR/CRi rates after one cycle were comparable (66.1%vs.58.3%; p = 0.38). FLAMSA was associated with shorter durations of neutropenia (25.5 vs.29 days; p = 0.031), thrombocytopenia (23.5 vs.30.5 days; p < 0.001), and hospitalization (24.5 vs.31 days; p = 0.02), as well as a lower incidence of bacterial pneumonia (16.7%vs.38.7%; p = 0.04) and septic shock or ICU admission (12.5%vs.35.5%; p = 0.03). In the AML subgroup, post-transplant survival was numerically higher in patients treated with FLAG-IDA (2-year OS: 66.4% vs. 36.2%, p = 0.11; 2-year RFS: 63.4% vs. 33.7%, p = 0.07), although differences did not reach statistical significance. In the ALL subgroup, survival outcomes were comparable between the two regimens (2-year OS: 47.0% vs. 33.3%, p = 0.83; 2-year RFS: 35.0% vs. 33.3%, p = 0.98). In multivariate analysis, the choice of salvage regimen (FLAMSA vs FLAG-IDA) was not associated with overall survival (HR 1.05, 95% CI 0.43-2.57; p = 0.899), whereas high-risk disease independently predicted inferior survival (HR 3.24, 95% CI 1.36-7.75; p = 0.008). Among patients relapsing after Allo-HCT (n = 16), CR/CRi rates and the proportion proceeding to second transplantation did not differ. In this single-center cohort, FLAMSA was associated with a more favorable toxicity profile than FLAG-IDA, while overall outcomes were broadly comparable between the two regimens. Given the potential impact of historical confounding, these findings warrant validation in additional cohorts.