- In childhood acute myeloid leukemia (AML), low-dose clofarabine+cytarabine during remission induction reduced daunorubicin and etoposide exposure without a significant difference in 3-year survival.
Why this matters
- Anthracycline-associated late cardiotoxicity remains a significant problem in this setting.
- AMLO8 phase 3 trial to investigate replacement of daunorubicin+etoposide with low-dose clofarabine during remission induction in pediatric patients with AML.
- Induction I: 129 patients received clofarabine+cytarabine (Clo+AraC); 133 received high-dose cytarabine, daunorubicin, and etoposide (HD-ADE).
- Induction II and consolidation therapies were assigned on an individualized basis.
- Funding: NIH; American Lebanese Syrian Associated Charities.
- On induction I, day 22:
- 47% of patients were minimal residual disease (MRD) positive with Clo+AraC vs 35% with HD-ADE: HR, 1.86; 95% CI, 1.03-3.41; P=.04.
- After induction II:
- 93.0% (95% CI, 87.2%-96.8%) complete remission with Clo+AraC vs 92.5% (95% CI, 86.6%-96.3%) with HD-ADE (P=1.0).
- 52.9% (95% CI, 44.6%-62.8%) 3-year event-free survival with Clo+AraC vs 52.4% (95% CI, 44.0%-62.4%) with HD-ADE (P=.95).
- 74.8% (95% CI, 67.1%-83.3%) 3-year OS with Clo+AraC vs 64.6% (95% CI, 56.2%-74.2%) with HD-ADE (P=.1).
- Study was not powered for survival outcomes.