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Relapse-related mortality remains the leading cause of death in older patients with acute myeloid leukemia (AML) who are not candidates for potentially curative allogeneic stem cell transplantation (SCT).
To determine the efficacy and safety of maintenance chemotherapy with the hypomethylating agent azacitidine, investigators conducted an industry-sponsored, multicenter, phase 3 trial of the oral formulation of azacitidine versus placebo in 472 patients 55 years of age or older with de novo AML without intermediate- or poor-risk cytogenetics. Patients were not candidates for SCT, were <4 months from completion of induction and consolidation chemotherapy, and had neutrophil counts >500/mm3 and platelet counts >20,000/mm3; 85% received ≥2 cycl…