Prospective study of a pirarubicin, intermediate-dose cytarabine, and etoposide regimen in children with Down syndrome and acute myeloid leukemia: the Japanese Childhood AML Cooperative Study Group

J Clin Oncol. 2007 Dec 1;25(34):5442-7. doi: 10.1200/JCO.2007.12.3687.

Abstract

Purpose: To evaluate a less intensive chemotherapeutic regimen specifically designed for patients with Down syndrome (DS) and acute myeloid leukemia (AML), and to determine the prognostic factors for event-free survival.

Patients and methods: Seventy-two patients with AML-DS were treated with remission induction chemotherapy consisting of pirarubicin (25 mg/m2/d for 2 days), cytarabine (100 mg/m2/d for 7 days), and etoposide (150 mg/m2/d for 3 days). Patients received four courses of intensification therapy of the same regimen. Prophylaxis for CNS leukemia was not included.

Results: All but two patients were younger than 4 years, and 67 of the 72 patients (93%) were diagnosed as acute megakaryoblastic leukemia (AMKL). Seventy of the 72 patients (97.2%) achieved a complete remission (CR), and the estimated 4-year event-free survival (EFS) rate was 83% +/- 9%. Nine patients relapsed, and one died as a result of pneumonia during CR. Multivariate analysis revealed that the presence of monosomy 7 was a greater risk factor of adverse outcome (odds ratio = 5.67; P = .027).

Conclusion: A less intensive chemotherapeutic regimen produces excellent outcomes in standard-risk AML-DS patient. Risk-oriented therapy should be considered for future trials in AML-DS.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Child
  • Child, Preschool
  • Cytarabine / administration & dosage
  • Disease-Free Survival
  • Down Syndrome / complications*
  • Doxorubicin / administration & dosage
  • Doxorubicin / analogs & derivatives
  • Etoposide / administration & dosage
  • Female
  • Humans
  • Infant
  • Leukemia, Megakaryoblastic, Acute / complications
  • Leukemia, Megakaryoblastic, Acute / drug therapy*
  • Male
  • Prospective Studies
  • Treatment Outcome

Substances

  • Cytarabine
  • Etoposide
  • Doxorubicin
  • pirarubicin