High efficacy and low toxicity of APL induction with concurrent idarubicin/ATRA followed by a novel and simplified outpatient post-remission therapy using single doses of idarubicin and intermittent ATRA

Med Oncol. 2010 Sep;27(3):702-7. doi: 10.1007/s12032-009-9272-2. Epub 2009 Aug 8.

Abstract

Acute promyelocytic leukemia (APL) is one of the most curable myeloid malignancies because of its great sensitivity to all-trans retinoic acid (ATRA) and response to anthracycline therapy. In an attempt to simplify post-remission therapy, deliver adequate dose of anthracycline and reduce treatment related toxicity, we entered 26 consecutively newly diagnosed, previously untreated APL patients in a pilot treatment program consisting of concurrent induction using idarubicin/ATRA followed by an exclusive outpatient post-remission therapy using single dose of idarubicin and intermittent ATRA, every 4 weeks. Of 25 evaluable patients, two (8%) died early during induction due to hemorrhagic complications, and 23 (92%) achieved complete remission. Overall survival at 4.2 years was 90% (CI 76.4-100), and 3.6 years disease-free survival was 78% (CI 60.6-95.4). The treatment outcome of this program is encouraging; however, the result of this study needs to be validated in larger cohort of patients and optimally in a randomized comparison with other current post-remission approaches.

Publication types

  • Clinical Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Ambulatory Care
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Clinical Trials as Topic / statistics & numerical data
  • Dexamethasone / administration & dosage
  • Disease-Free Survival
  • Drug Administration Schedule
  • Factor VIII / therapeutic use
  • Female
  • Fibrinogen / analysis
  • Fibrinogen / therapeutic use
  • Hemorrhage / chemically induced
  • Hemorrhage / drug therapy
  • Humans
  • Idarubicin / administration & dosage
  • Idarubicin / adverse effects
  • Kaplan-Meier Estimate
  • Leukemia, Promyelocytic, Acute / drug therapy*
  • Male
  • Middle Aged
  • Pilot Projects
  • Remission Induction
  • Tretinoin / administration & dosage
  • Tretinoin / adverse effects
  • Young Adult

Substances

  • cryoprecipitate coagulum
  • Tretinoin
  • Dexamethasone
  • Factor VIII
  • Fibrinogen
  • Idarubicin