Oral azacitidine maintenance therapy for acute myeloid leukemia in first remission
New England Journal of Medicine Jan 07, 2021
Wei AH, Döhner H, Pocock C, et al. - In patients suffering from acute myeloid leukemia (AML) who were in first remission after intensive chemotherapy, researchers conducted a phase 3, randomized, double-blind, placebo-controlled trial to investigate the impacts of the oral formulation of azacitidine (CC-486, a hypomethylating agent not bioequivalent to injectable azacitidine) as maintenance treatment. Randomization was performed among patients who were 55 years of age or older who were in complete remission with or without complete blood count recovery, and were not candidates for hematopoietic stem-cell transplantation to assign them to receive CC-486 (300 mg) or placebo once daily for 14 days per 28-day cycle. In older patients with AML who were in remission following chemotherapy, significantly longer overall and relapse-free survival were conferred by CC-486 maintenance therapy vs placebo. Side effects included primarily gastrointestinal symptoms and neutropenia. Throughout therapy, quality-of-life measures were maintained.
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