Abstract: Introduction: Treatment of acute myeloid leukemia (AML) in elderly or medically unfit patients remains challenging. Although low-intensity regimens are now standard, intermediate-intensity approaches may still be relevant in selected clinical scenarios. FLAG-IDA LITE was developed as a reduced-intensity adaptation of fludarabine- and cytarabine-based induction to preserve antileukemic activity while improving tolerability. Patients and methods: We conducted a retrospective analysis of elderly or unfit patients with de novo or secondary AML treated with FLAG-IDA LITE at a single institution between 2006 and 2020. Responses were assessed according to Cheson criteria, and cytogenetic risk was classified using the 2010 Medical Research Council (MRC) criteria. Overall survival (OS) was calculated from day 1 of treatment. Results: Ninety-one patients were included, with a median age of 76 years and a high burden of comorbidities and adverse disease features. Complete remission (CR) or CR with incomplete hematologic recovery (CRi) was achieved in 52 patients (57%). Thirty-day mortality was 9.8%, mainly due to infectious complications during induction. Median OS for the entire cohort was 7 months. Patients achieving CR/CRi had a significantly prolonged median OS compared with nonresponders (19 vs. 4 months). Adverse-risk cytogenetics were associated with lower response rates and inferior survival. Conclusions: In conclusion, FLAG-IDA LITE yielded modest overall outcomes in a highly vulnerable AML population but provided meaningful survival benefit in patients achieving remission. These findings support a selective role for intermediate-intensity induction regimens in carefully chosen elderly or unfit patients, particularly when rapid disease control is required.

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