Abstract
Venetoclax plus azacitidine improves survival in older or unfit patients with newly diagnosed acute myeloid leukemia (AML), as demonstrated in the VIALE‐A trial.
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However, real‐world data in hospitalized patients—particularly those with secondary AML or adverse‐risk mutations—remain limited. We conducted a retrospective study of exclusively hospitalized patients with treatment‐naïve AML who completed at least one full 28‐day cycle of azacitidine and venetoclax at Baylor University Medical Center between October 2019 and October 2024, with the aim of evaluating outcomes at a clinically relevant treatment inflection point. Risk stratification was performed using ELN 2022 criteria, and safety was assessed using CTCAE v5.0. Fifty‐six patients met inclusion criteria (median age 71 years); 51.8% had secondary AML, and 53.7% had adverse‐risk disease. Among 43 evaluable patients, the composite complete remission (CRc) rate after one cycle was 55.8%. Median overall survival (OS) was 17.6 months. Patients with TP53 mutations had significantly shorter median OS (3.8 months) compared with those without TP53 mutations (20.2 months). Common grade ≥ 3 toxicities included leukopenia (67.8%) and febrile neutropenia (57.6%). By focusing on patients who completed an initial treatment cycle, this study provides conditional survival estimates that may inform decisions regarding continuation of therapy. Despite the predominance of secondary and adverse‐risk AML in this cohort, OS was comparable to that observed in VIALE‐A, supporting the effectiveness of azacitidine plus venetoclax in hospitalized AML patients ineligible for intensive chemotherapy.