Efficacy and safety of venetoclax-based regimens versus intensive chemotherapy in older adults with newly diagnosed acute myeloid leukemia: a single-center retrospective study.

Venetoclax (VEN) has emerged as a frontline therapy for older adults with acute myeloid leukemia (AML), yet its advantages over intensive chemotherapy (IC) remain uncertain. This single-center retrospective study compared the efficacy and safety of VEN-based regimens (n = 35) with IC (n = 54) in newly diagnosed patients with AML aged ≥ 65 years. No significant differences were found in the primary endpoints of median event-free survival (190.0 vs. 84.5 days, p = 0.20) or median overall survival (324 vs. 273 days, p = 0.30). However, the VEN group demonstrated a significantly higher overall response rate (71% vs. 48%, p = 0.03) and a more favorable safety profile. Notably, 30-day mortality was 0% in the VEN group compared to 16.7% in the IC group. Rates of Grade ≥ 3 cytopenias and febrile neutropenia were also significantly lower in the VEN group. These findings suggest that VEN-based regimens offer comparable survival with improved response rates and reduced early mortality, supporting their use as an effective and safer alternative to IC even for some IC-eligible older adults with AML, though these conclusions are drawn from a single-center, retrospective study.