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| Message: 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 stem-cell 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 cytarabine-based 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 intermediate-risk 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 relapse-free 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 treatment-related deaths (9 versus 4) were higher in the oral azacitidine group than in the placebo group. However, no meaningful differences in patient-reported quality of life were observed between treatment groups using questionnaires to evaluate changes from baseline scores.
"this oral agent represents an attractive option for patients for whom outpatient treatment is preferred"
On the basis of these findings, on 1 September 2020 the FDA approved oral azacitidine for the maintenance treatment of adults with AML in first remission after intensive chemotherapy. "Looking forward, this oral agent represents an attractive option for patients for whom outpatient treatment is preferred," explains Wei. "Future clinical trials will address the feasibility and efficacy of oral azacitidine in combination with other orally administered targeted agents, for example, venetoclax," he adds. In addition, a randomized trial is evaluating oral azacitidine as maintenance therapy for AML after consolidative HSCT. The results of this study are eagerly awaited.
References
Original article
Wei, A. H. et al. Oral azacitidine maintenance therapy for acute myeloid leukemia in first remission. N. Engl. J. Med. 383, 2526–2537 (2020)
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