344P - Venetoclax and azacitidine compared with azacitidine monotherapy for acute myeloid leukemia patients: A systematic review and meta-analysis

Background

Acute myeloid leukemia (AML) is primarily treated with chemotherapy. Patients who are unable to undergo intensive chemotherapy may receive substitutional therapy, such as venetoclax, a BCL-2 inhibitor that showed promising results by combining it with azacitidine. Recent clinical trials have demonstrated the effectiveness of venetoclax-azacitidine in AML treatment. Thus, this review aims to compare the efficacy and serious adverse events (SAE) of venetoclax-azacitidine vs azacitidine used alone in patients diagnosed with AML.

Methods

Authors independently extracted studies from 2013 to 2023 using databases such as Pubmed, Pubmed Central, Springer Link, ScienceDirect, Medrxiv, and Google Scholar. Keywords used were "venetoclax" AND "azacitidine" AND "acute myeloid leukemia". We assessed the quality of each study using the modified JADAD scale with funnel plot to assess publication bias and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) to determine the quality of this review. A pooled analysis of OS and EFS hazard ratio (HR) and SAE ratio between the two groups were done to establish correlation.

Results

We included 7 records, representing 3 trials, involving 1499 patients. 2 studies were of low quality, with the other 3 studies and the other 2 studies were of moderate and high quality respectively. This review showed moderate quality based on GRADE with minimum publication bias. The use of combining venetoclax and azacitidine did improve OS (HR = 0.58; 95% CI 0.51-0.65 ; P < 0.001) and EFS (HR = 0.50 ; 95% CI 0.30-0.84 ; P = 0.008), but have higher SAE (OR = 1.81 ; 95% CI 1.29-2.52 ; P = 0.0005) compared to azacitidine alone.

Conclusions

This review revealed that venetoclax-azacitidine demonstrated enhanced OS and EFS outcomes, with higher serious adverse events (SAE) when compared to azacitidine in AML patients. This concludes that venetoclax-azacitidine holds promise as a potential treatment for AML patients although its safety still needs to be monitored closely. Further studies needed to observe the administration of venetoclax-azacitidine vs azacitidine AML in different subgroups, more importantly the cytogenetic risk.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.