Consolidation with arsenic trioxide (ATO) allows a decrease in the cumulative dose of anthracycline while maintaining survival rates and a low risk of relapse among pediatric patients with acute promyelocytic leukemia (APL), according to research published in the Journal of Clinical Oncology.1

The AIDA0493 ( Identifier: NCT01064557) clinical trial previously established the current control for patients with APL, though high-dose anthracycline carries an increased risk of cardiac toxicity.

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In the AAML0631 phase 3 study ( Identifier: NCT00866918) researchers enrolled 100 pediatric patients with standard-risk (SR) or high-risk (HR) APL. Patients received all-trans retinoic acid (ATRA) 25 mg/m2/day twice daily on days 1 to 30 during induction, and on days 1 to 14 during every consolidation and maintenance course. All patients received idarubicin for induction, 2 cycles of ATO for consolidation, and 6-mercaptopurine and oral methotrexate for maintenance. 

SR and HR patients received 2 and 3 additional cycles of consolidation, respectively, which included high-dose cytarabine and idarubicin.

The 3-year overall survival (OS) was 94% in evaluable study patients. The OS was 98% for SR patients vs 86% for HR patients (P = .003).

Event-free survival was 91% for all patients; EFS was 95% in SR patients vs 83% in HR patients (P = .03).

The most frequently observed adverse effects (AEs) were fever, neutropenia, and infection. AEs also included grades 1 to 5 QTc prolongation, ventricular arrhythmia, or left ventricular dysfunction.

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The authors concluded that “the favorable results of this study incorporating ATO consolidation with reduced anthracycline dose provide a new benchmark for outcome in pediatric APL.”


  1. Kutny MA, Alonzo TA, Gerbing RB, et al. Arsenic trioxide consolidation allows anthracycline dose reduction for pediatric patients with acute promyelocytic leukemia: report from the Children’s Oncology Group phase III historically controlled trial AAML0631. J Clin Oncol. 2017 Aug 2. doi: 10.1200/JCO.2016.71.6183 [Epub ahead of print]