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Arsenic trioxide dose capping to decrease toxicity in the treatment of acute promyelocytic leukemia.

Kyle Zacholski1, Bryan Hambley2, Erin Hickey3

  • 1The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital Department of Pharmacy, Baltimore, USA.

Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners
|June 17, 2021
PubMed
Summary
This summary is machine-generated.

Capping arsenic trioxide (ATO) doses at 10 mg in acute promyelocytic leukemia (APL) treatment did not increase toxicity during induction. However, higher doses during consolidation were linked to greater neurotoxicity, suggesting a safer dosing strategy.

Keywords:
Acute promyelocytic leukemiaarsenic trioxidecapped doseobesitytoxicity

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Area of Science:

  • Hematology
  • Oncology
  • Clinical Pharmacology

Background:

  • Arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) combination therapy is highly effective for acute promyelocytic leukemia (APL).
  • ATO dosing based on actual body weight may lead to increased toxicity in overweight patients.

Purpose of the Study:

  • To compare toxicities between capped (≤10 mg/dose) and non-capped (>10 mg/dose) ATO regimens in APL patients.
  • To evaluate the safety and efficacy of dose-capped ATO in combination with ATRA.

Main Methods:

  • Retrospective, two-center study of 44 APL patients receiving ATRA/ATO.
  • Patients were divided into two groups: capped ATO (≤10 mg/dose) and non-capped ATO (>10 mg/dose).
  • Toxicity assessments included hepatotoxicity, QTc prolongation, neurotoxicity, and cardiac toxicity during induction and consolidation.

Main Results:

  • No significant differences in grade ≥3 hepatotoxicity, QTc prolongation, or cardiac toxicity were observed during induction.
  • Consolidation therapy showed a higher incidence of neurotoxicity in the group receiving >10 mg/dose ATO (66.7% vs 22.2%, p=0.046).
  • Dose capping resulted in cost savings and reduced waste, with no disease relapses at 27 months median follow-up.

Conclusions:

  • Capping ATO doses at 10 mg/dose may improve the safety profile of ATRA/ATO therapy, particularly during consolidation, by reducing neurotoxicity.
  • This strategy maintains high efficacy and offers economic benefits without compromising disease-free survival.