Idarubicin vs High-Dose Daunorubicin Induction in Newly Diagnosed Acute Myeloid Leukemia


Key Points

  • In newly diagnosed patients with acute myeloid leukemia, no significant differences in complete remission rate, relapse, overall survival, or event-free survival were observed between high-dose daunorubicin vs idarubicin.
  • High-dose daunorubicin appeared to be associated with better outcomes in patients with FLT3-ITD mutation.

A Korean phase III trial has shown no difference in outcomes with high-dose daunorubicin vs idarubicin induction in newly diagnosed acute myeloid leukemia, although high-dose daunorubicin was associated with better outcomes in patients with FLT3–internal tandem duplication (ITD) mutation. These findings were reported in the Journal of Clinical Oncology by Lee et al.

Study Details

In the trial, 299 patients aged < 65 years from 8 sites were randomized between May 2010 and March 2014 to receive induction with idarubicin at 12 mg/m2/d for 3 days (n = 149) or high-dose daunorubicin at 90 mg/m2/d for 3 days (n = 150), with all patients receiving cytarabine at 200 mg/m2/d for 7 days. The primary outcome measure was complete remission.

Efficacy Outcomes

Complete remission was observed in 80.5% of the idarubicin group vs 74.7% of the daunorubicin group (P = .224). Median follow-up was 34.9 months. Four-year rates were 51.4% vs 54.7% (P = .756) for overall survival, 35.2% vs 25.1% (P = .194) for cumulative incidence of relapse, and 45.5% vs 50.8% (P = .772) for event-free survival.

Among the 21% and 14% of patients in the idarubicin and daunorubicin groups with FLT3-ITD mutation, median overall survival (15.5 months vs not reached, P = .030) and event-free survival (11.9 months vs not reached, P = .028) were better in the daunorubicin group.

Toxicity profiles were similar in the two groups.

The investigators concluded: “This phase III trial comparing idarubicin with high-dose daunorubicin did not find significant differences in [complete remission] rates, relapse, and survival. Significant interaction between the treatment arm and the FLT3-ITD mutation was found, and high-dose daunorubicin was more effective than idarubicin in patients with FLT3-ITD mutation.”

The study was supported by the Korean Cooperative Study Group A for Hematology.

Je-Hwan Lee, MD, of the University of Ulsan College of Medicine, Seoul, is the corresponding author of the Journal of Clinical Oncology article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.