ABSTRACT The standard of care for newly‐diagnosed unfit patients with acute myeloid leukemia (AML) is venetoclax (VEN) with azacitidine (AZA). In the phase 3 trial, before remission, AZA was given with 28 days of VEN. This regimen is myelosuppressive; therefore, many decrease VEN duration before and/or after initial response assessment. We report our center's outcomes administering 28 days of VEN preremission, and in most cases, postremission, relying on other strategies to reduce cytopenias. All newly‐diagnosed patients with AML treated outside of a clinical trial with VEN/AZA for > 7 days at our center from 2018 to 2024 were reviewed. 134 patients met inclusion criteria; median age was 70 years (interquartile range IQR 64–76), 57% male, and 63% had European LeukemiaNet adverse risk AML (85/134). Overall response rate (including complete remission and complete remission with incomplete hematologic recovery) was 87/134 (64.9%). Median cycles completed was 2 (IQR 1–3, range 0–26), with 117 (87%) completing ≥ 1 cycle with a response assessment. Median duration of cycles 1–5 was 42 days. Median overall survival was 381 days. Prior to response assessment, 113/117 (96.6%) received 28 days of VEN. Postresponse, 17/81 (21.0%) had a VEN reduction (in duration or dose). Grade ≥ 3 neutropenia or thrombocytopenia was higher in cycle 1 than in similar studies, without differences in transfusion needs or infectious complications. Hematologic toxicities improved with subsequent cycles. Serial cycles with 28 days of VEN can be administered pre‐ and postremission with higher early myelosuppression but similar transfusion and infection rates compared to studies of reduced VEN duration.
Jones et al. (Fri,) studied this question.