Nature Reviews Clinical Oncology | 2021
New maintenance option for AML
Abstract
132 | mARCH 2021 | volume 18 Approximately 50% of patients with acute myeloid leukaemia (AML) aged ≥55 years have complete remission after standard induction chemotherapy, but eventually the majority have disease relapse. Haematopoietic stemcell transplantation (HSCT) is not always feasible for patients in this age group and, therefore, maintenance therapies might be warranted to prolong remission. Now, data from the phase III QUAZAR AML-001 trial demonstrate promising overall survival (OS) outcomes with oral azacitidine in this setting. In QUAZAR AML-001, patients with AML in complete remission after induction with cytarabinebased chemotherapy and aged ≥55 years were randomly assigned to receive oral azacitidine (n = 238) or placebo (n = 234). The median age was 68 years; 91% of patients had de novo AML, 86% had intermediaterisk cytogenetic characteristics and 80% had received consolidation chemotherapy. Median OS was significantly longer for patients receiving oral azacitidine than for those receiving placebo (24.7 months versus 14.8 months; P < 0.001). Median relapsefree survival was also significantly longer with oral azacitidine (10.2 months versus 4.8 months; P < 0.001). “The OS benefit with oral azacitidine was observed across different subgroups, including patients with persistent measurable residual disease after intensive chemotherapy,” comments lead investigator Andrew Wei. The incidence of grade 3–4 adverse events (72% versus 63%) and the number of treatmentrelated deaths (9 versus 4) were higher in the oral azacitidine group than H A E M AtO lO g i C A l C A N C E R