- A pooled analysis of real-world patients with acute myeloid leukemia (AML) suggests frontline decitabine is safe and effective in patients not eligible for standard intensive chemotherapy.
Why this matters
- Decitabine has been approved for the treatment of AML in patients ineligible for standard chemotherapy; however, real-world studies are needed to confirm outcomes in unselected populations.
- Pooled analysis to investigate outcomes with frontline decitabine in 306 patients with AML who were unfit for standard chemotherapy.
- 54% of patients were aged >75 years.
- 30.4% had adverse cytogenetics per Medical Research Council (MRC) classification.
- Funding: None disclosed.
- 48.4% overall response rate (ORR).
- 23.2% complete response (CR).
- 10.5% partial response (PR).
- Median OS in patients with favorable-intermediate cytogenetic risk was 10.0 (95% CI, 7.9-11.9) months vs 6.0 months with adverse cytogenetic profile.
- Factors associated with increased mortality in multivariate analysis:
- Adverse vs favorable/intermediate cytogenetic classification: HR, 1.58; 95% CI, 1.13-2.21.
- Increasing white blood cell count: HR, 1.12; 95% CI, 1.06-1.18.
- 44.4% experienced an infectious adverse event, with pneumonia (41.5% of cases) being the most common.
- Differences between studies in the pooled analysis prohibited inclusion of some covariates.