Frontline AML: real-world data confirm decitabine safety, efficacy

  • Bocchia M & al.
  • Hematol Oncol
  • 5 Aug 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitations

  • Differences between studies in the pooled analysis prohibited inclusion of some covariates.