Azacitidine-Venetoclax in Elderly and Unfit Acute Myeloid Leukemia: Real-World Outcomes Outside Clinical Trials

Background

Azacitidine plus venetoclax (AZA+VEN) is the current standard first-line treatment for elderly or medically unfit patients with acute myeloid leukemia (AML). However, patients treated in real-world settings often differ from those enrolled in clinical trials due to frailty, comorbidities, secondary AML, and prior exposure to hypomethylating agents. Materials and Methods: We retrospectively analyzed 21 consecutive AML patients who received frontline AZA+VEN between October 2020 and May 2026. Patient fitness was assessed according to SIE/SIES/GITMO criteria. Data on treatment responses, toxicities, treatment modifications, survival outcomes, ELN 2022/2024 risk categories, and comorbidity burden, including HCT-CI and augmented HCT-CI scores, were collected.