AZA-AML-001: azacitidine versus conventional care in older patients with acute myeloid leukaemia and more than 30 percent blasts
In older people with acute myeloid leukaemia who were not good candidates for intensive chemotherapy, azacitidine lengthened median survival by about four months compared with the usual options and became the backbone that venetoclax was later added to.
Overview
Phase 3 trial of 488 patients aged 65 or over with newly diagnosed AML and over 30 percent marrow blasts, randomised to azacitidine or a pre-selected conventional care regimen (intensive chemotherapy, low-dose cytarabine or supportive care).
Median overall survival was 10.4 months with azacitidine against 6.5 months with conventional care, a difference that was clinically meaningful but not statistically significant in the primary analysis. One-year survival was 46.5 versus 34.2 percent.
- Median overall survival 10.4 vs 6.5 months (hazard ratio 0.85, not significant in the primary analysis).
- One-year survival 46.5 percent vs 34.2 percent.
Azacitidine became the standard low-intensity treatment for older or unfit patients with AML and the control arm for later trials; venetoclax plus azacitidine (VIALE-A) now supersedes azacitidine alone where available.
- The primary endpoint was not formally met.
- The comparator was heterogeneous and chosen by the investigator before randomisation.
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