Comparative Outcomes of Intensive Chemotherapy Versus Venetoclax Plus Hypomethylating Agents in Acute Myeloid Leukemia Patients Aged 60-75 Years: A Propensity Score-Adjusted Cohort Study.

[BACKGROUND] Venetoclax (VEN) combined with hypomethylating agents (HMA) is established as standard of care for elderly or unfit patients with newly diagnosed acute myeloid leukemia (AML). While emerging evidence supports its use in fit, younger patients, data on its comparative efficacy versus intensive chemotherapy (IC) remain limited.

[METHODS] We conducted a retrospective cohort study to compare composite complete response (CCR), overall survival (OS), and event-free survival (EFS) in patients with AML who received 7 + 3 IC vs. HMA+VEN. All AML patients aged 60-75 years treated between 1/2015 and 9/2023 were included. Propensity score (PS) adjustment and multivariable regression were used to adjust outcomes.

[RESULTS] The study included 172 patients who received 7 + 3 and 74 who received HMA+VEN. After adjustment, the average age was -68 years in both groups. The CCR was significantly lower with HMA+VEN (51.4%) than with 7 + 3 (66.9%; P = .025), but this was not significant in the weighted logistic regression model (OR: 0.65, 95% CI: 0.32-1.32, P = .2). PS-adjusted median OS was 18.0 months for 7 + 3 vs. 9.5 months for HMA+VEN (P = .14). VEN+HMA was associated with similar PS-adjusted median EFS (7.2 vs. 7 months, P = .91) compared to 7 + 3. Allogeneic transplant was not different between 7 + 3 and HMA+VEN (48% vs. 24%, log-rank P = .6).

[CONCLUSIONS] In AML patients aged 60-75 years, HMA + VEN achieved CCR, OS, and EFS comparable to those of the 7 + 3 regimen, consistent with previous reports. However, our analysis may be underpowered or confounded, and a sufficiently powered randomized trial is needed to definitively assess the efficacy, toxicity, and cost-effectiveness of HMA + VEN vs. 7 + 3.