The efficacy and safety of venetoclax combined with decitabine in elderly patients with acute myeloid leukemia: a systematic review and meta-analysis.

Acute Myeloid Leukemia (AML) carries a high mortality rate in elderly patients who often face limited treatment options and a poor overall prognosis. The combination of Venetoclax (VEN) and Decitabine (DEC) is recommended for treatment, yet there is insufficient evidence to fully support its efficacy. This study aims to perform a meta-analysis to evaluate the effectiveness and safety of the VEN + DEC regimen in treating elderly patients with AML. We systematically searched PubMed, EMBASE, the Cochrane Library, CNKI, and WanFang. Efficacy was evaluated using complete remission (CR), composite response rate, overall response rate, and median overall survival. Safety was assessed based on adverse events. The fixed/random effect model was employed to evaluate the effect sizes. Seven articles were included in this meta-analysis. VEN + DEC group (OR 1.90, 95%CI 1.36-2.67) could significantly improve CR among the elderly patients with AML, compared to the control group. VEN + DEC was associated with a significantly lower risk of death (HR 0.55, 95%CI 0.40-0.75). VEN (400 mg) + DEC group (OR 1.99, 95%CI 1.37-2.87) could significantly increase CR. Subgroup analysis reported that there were significant differences in both any grade (OR 1.99, 95%CI 1.18-3.35) and grade 3/4 febrile neutropenia (OR 1.99, 95%CI 1.18-3.35) between VEN + DEC group and the control group. Our findings demonstrated that the VEN + DEC regimen is both effective and safe for treating elderly patients with AML. Besides, the combination of VEN (400 mg) with DEC had relatively high rate of CR.Trial registration We have registered out study on PROSPERO with the registration number CRD42024554185.