For the multicenter, open-label, phase III trial, researchers enrolled 488 patients at least 65 years of age with newly diagnosed AML with >30% bone marrow blasts. Patients were randomly assigned 1:1 to receive azacitadine or a conventional care regimen, which included either standard induction chemotherapy, low-dose cytarabine, or supportive care only.
Results showed that median overall survival was 10.4 months (95% CI: 8.0-12.7) in the azacitadine group compared with 6.5 months (95% CI: 5.0-8.6) in the conventional care group (HR = 0.85; 95% CI: 0.69-1.03; P = 0.1009). Researchers found that the 1-year survival rates were 46.5% and 34.2% with azacitadine and conventional care regimens, respectively.
In regard to safety, adverse events were similar to those observed in previous studies with azacitadine.
Azacitidine increased median overall survival by 3.8 months (10.4 vs 6.5 months, P=.1009) versus commonly used current AML treatments. Azacitidine safety in patients aged ≥65 years with AML (>30% blasts) was consistent with its known safety profile in other trials.