Pediatric Acute Promyelocytic Leukemia: Arsenic Trioxide Consolidation May Improve Outcomes

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Consolidation with ATO allows a decrease in the cumulative dose of anthracycline while maintaining survival rates and a low risk of relapse among pediatric patients with APL.
Consolidation with ATO allows a decrease in the cumulative dose of anthracycline while maintaining survival rates and a low risk of relapse among pediatric patients with APL.

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

In the AAML0631 phase 3 study (ClinicalTrials.gov 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.”

Reference

  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]

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