Hematology · 2 h ago
Early HbF rise associated with remission response to decitabine in AML
A biomarker analysis of the randomized phase III AML21 trial examined fetal haemoglobin (HbF) in older adults with acute myeloid leukaemia. Among patients receiving decitabine, an HbF increase by day 10 was associated with higher odds of complete remission or remission with incomplete count recovery, but not significantly longer overall survival.
- Day-10 HbF rise associated with higher odds of CR/CRi.
- Survival association was not statistically significant.
- Baseline HbF was not associated with outcomes.
- Analysis included 135 decitabine-treated patients with serial HbF measurements.
The AML21 randomized phase III trial enrolled 606 fit, older adults with acute myeloid leukaemia (AML) assigned to 10-day decitabine or ‘3 + 7’ chemotherapy. This analysis assessed HbF as a potential early response biomarker. HbF was measured at baseline and day 10 in 135 patients in the decitabine arm, and at baseline in 97 patients receiving ‘3 + 7’. Outcomes included complete remission or complete remission with incomplete count recovery (CR/CRi) and overall survival.
In the decitabine group, an HbF increase from baseline to day 10 was associated with higher odds of CR/CRi (odds ratio 2.40, 95% CI 1.15–5.02; p=0.020). The association with overall survival was not statistically significant (hazard ratio 0.83, 95% CI 0.55–1.28; p=0.40). Baseline HbF was not associated with either CR/CRi or overall survival.
The findings support further evaluation of early HbF change as a response biomarker during hypomethylating-agent treatment. The reported association does not establish that HbF-guided treatment decisions improve outcomes; survival benefit was not demonstrated, and the analysis included a subset of the trial population.
In practice
For fit, older adults with AML receiving 10-day decitabine, an HbF increase by day 10 was associated with higher odds of CR/CRi in this analysis. The finding may support further assessment of HbF as an early response marker, but it does not establish that HbF-guided treatment changes improve outcomes. An association with overall survival was not statistically significant, and the analysis included 135 decitabine-treated patients with serial HbF measurements.
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British Journal of Haematology: Increase in fetal haemoglobin from baseline to day 10 is a biomarker for response to decitabine in AML : Results of the AML21 randomized phase III trial of the EORTC Leukemia Group, Gruppo Italiano Malattie Ematologiche dell'Adulto ( GIMEMA) and German MDS Study Group ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.