Azacitidine in combination with intensive induction chemotherapy in older patients with acute myeloid leukemia: The AML-AZA trial of the Study Alliance Leukemia.

摘要: DNA methylation changes are a constant feature of acute myeloid leukemia. Hypomethylating drugs such as azacitidine active in leukemia (AML) monotherapy. Azacitidine monotherapy is not curative. The AML-AZA trial tested the hypothesis that methyltransferase inhibitors can improve chemotherapy outcome AML. This randomized, controlled compared efficacy applied before each cycle intensive with alone older patients untreated Event-free survival (EFS) was primary end point. In total, 214 median age 70 years were randomized to azacitidine/chemotherapy (arm-A) or (arm-B). More arm-A (39/105; 37%) than arm-B (25/109; 23%) showed adverse cytogenetics (P=0.057). Adverse events more frequent (15.44) versus 13.52 arm-B, (P=0.26), but early death rates did differ significantly (30-day mortality: 6% 5%, P=0.76). Median EFS 6 months both arms (P=0.96). overall 15 for 21 (P=0.35). added standard increases toxicity AML, provides no additional benefit unselected patients.