QUAZAR AML-001: oral azacitidine maintenance for acute myeloid leukaemia in first remission
Older adults with acute myeloid leukaemia who took an azacitidine tablet for two weeks of every four after chemotherapy lived a median of ten months longer than those on placebo, with mostly gut side effects and no loss of quality of life.
Overview
Phase 3, randomised, double-blind, placebo-controlled trial of oral azacitidine (CC-486) 300 mg daily for 14 of 28 days as maintenance in 472 patients aged 55 or older with acute myeloid leukaemia in first remission after intensive chemotherapy who were not transplant candidates.
Median overall survival was 24.7 months with CC-486 against 14.8 months with placebo, and relapse-free survival was also significantly longer. Side effects were mainly gastrointestinal symptoms and neutropenia; quality-of-life measures were maintained.
- Median overall survival 24.7 months with oral azacitidine versus 14.8 months with placebo (hazard ratio 0.69, 95% CI 0.55 to 0.86; p 0.0009).
- Relapse-free survival significantly longer with oral azacitidine.
- Side effects mainly gastrointestinal and neutropenia; quality of life maintained.
The first maintenance therapy shown to lengthen survival in acute myeloid leukaemia; oral azacitidine (Onureg) was approved in the United States in 2020 for patients in first remission who cannot complete intensive curative therapy.
- Oral azacitidine is not bioequivalent to injectable azacitidine and the two are not interchangeable.
- Patients going to transplant were excluded.
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