Real World Experience of Azacitidine + Venetoclax in Acute Myeloid Leukemia Rigorously Following Management Guidelines from Clinical Trial

Introduction: Azacitidine + venetoclax is a new standard of care for acute myeloid leukemia not eligible for intensive chemotherapy. This combination is associated with hematological toxicities and some drug interactions. Real-world studies have shown a decrease in results and outcomes when compared to the VIALE-A study. Methods: We report here our single-center experience using AZA + VEN, rigorously following management guidelines from the VIALE-A study, applied to a real-life population. Results: Forty-two AML patients were analyzed. The complete remission (CR)/CR with incomplete recovery (CRi)/MLFS rate was 73.8% after 1 cycle with 51% CR/CRi and 80.9% after 2 cycles. Median overall survival was 18 months (95% CI, 10.3–25.7). Our retrospective study showed that rigorous use of AZA + VEN in a real-world setting was associated with results close to clinical trial observations. Conclusion: We showed the need to rigorously follow AZA+VEN dosage but also toxicity guidelines and practice recommendations edited in the clinical trial even in the real world.