Outcomes of Venetoclax‐Based Regimens Versus Intensive and Reduced‐Intensity Chemotherapy in Newly Diagnosed AML

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Abstract
Background: Venetoclax‐based regimens (VEN) have been widely adopted as frontline therapeutic options for elderly patients with acute myeloid leukemia (AML). However, comprehensive real‐world comparisons of VEN with conventional intensive or reduced‐intensity chemotherapy remain limited. Methods: In this multicenter retrospective study, we evaluated treatment patterns and outcomes in 1370 patients with newly diagnosed AML. Patients were classified into three cohorts according to their frontline treatment: intensive chemotherapy (IC), reduced‐intensity chemotherapy (rIC), or VEN. Analyses were performed in both the overall cohort and elderly patients (aged ≥ 60 years), including baseline comparisons, uni‐ and multivariable analyses, and subgroup analyses. Results: Baseline characteristics differed substantially among treatment cohorts; patients treated with VEN were older and had a higher prevalence of adverse‐risk disease than those receiving IC or rIC . In the overall cohort, VEN achieved an overall response rate ( ORR ) comparable to IC and higher than rIC (74.3% vs. 60.2%, p = 0.034). Among elderly patients, VEN was associated with a higher ORR than rIC (75.7% vs. 50.5%, p = 0.001), and the favorable ORR findings remained significant after correction for multiple testing. VEN was also associated with a lower 60‐day early‐death rate than rIC in elderly patients (1.4% vs. 20.0%, p < 0.001), suggesting better early treatment tolerability. Median event‐free survival was longer with VEN than with rIC in the primary elderly cohort analysis (9.6 vs. 6.6 months, p = 0.031), and this difference persisted in a sensitivity analysis censoring at allogeneic hematopoietic stem cell transplantation, although it was attenuated in landmark and propensity‐score‐based sensitivity analyses. Overall survival did not differ significantly between the two cohorts (15.9 vs. 11.0 months, p = 0.102). Conclusion: The higher response rate and lower early mortality with VEN were the most consistent findings, whereas comparative survival outcomes were considered supportive but exploratory.
Funding Information
  • Japan Society for the Promotion of Science (JP24K11568)

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