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QUAZAR AML-001 showed that a tablet form of azacitidine taken as maintenance after chemotherapy helped older people with acute myeloid leukaemia live about ten months longer than placebo, and it became the first approved maintenance treatment for the disease.
QUAZAR AML-001 was a double-blind, placebo-controlled phase 3 trial in 472 patients aged 55 and over with acute myeloid leukaemia in first complete remission (with or without count recovery) after induction with or without consolidation, who were not candidates for stem-cell transplant. Patients were randomised to oral azacitidine 300 mg or placebo once daily for 14 days per 28-day cycle. The primary endpoint was overall survival.
Median overall survival was 24.7 months with oral azacitidine against 14.8 months with placebo, and relapse-free survival was also longer. Side effects were mainly gastrointestinal symptoms and neutropenia, and quality-of-life scores were maintained. Oral azacitidine (Onureg) was approved in the United States in September 2020 for continued treatment of adults with acute myeloid leukaemia in first remission who cannot complete intensive curative therapy.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
472 enrolled.
95% CI 18.7 to 30.5; median follow-up 41.2 months · 95% CI 11.7 to 17.6
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Oral azacitidine + best supportive care | 238 | 24.7 months | 0.69 (0.55 to 0.86) | 0.0009 | link |
| Placebo + best supportive care | 234 | 14.8 months | ||||
| Relapse-free survival (registry, August 2024 cut-off) | Oral azacitidine + best supportive care | - | 10.2 months | 0.65 (0.52 to 0.8) | <0.0001 | link |
| Placebo + best supportive care | - | 4.8 months |
Shares Azacitidine, Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET) and the tag soc-trials.
Shares Leukaemia (all types), Acute myeloid leukaemia and the tag soc-trials.
Shares Leukaemia (all types), Acute myeloid leukaemia and the tag soc-trials.
Shares Leukaemia (all types) and the tag soc-trials.
Shares Leukaemia (all types) and the tag soc-trials.
Shares Leukaemia (all types) and the tag soc-trials.
Shares Leukaemia (all types) and the tag soc-trials.
Shares Leukaemia (all types) and the tag soc-trials.