Results of the first randomized multicentre trial on childhood acute lymphoblastic leukaemia in Russia

Leukemia. 2008 Jun;22(6):1144-53. doi: 10.1038/leu.2008.63. Epub 2008 Mar 27.

Abstract

Until 1990, the survival of children with acute lymphoblastic leukaemia (ALL) in Russia was below 10%. To establish a protocol feasible under conditions there, ALL-MB 91 was designed to avoid prolonged bone marrow aplasia, thereby reducing needs for extensive supportive care, blood transfusions, long-lasting hospitalization and costs. High-dose therapies were avoided, anthracycline use was limited and CNS radiation therapy only foreseen in high-risk patients (about 30%). This was randomized against a modified BFM protocol. From 1995 to 2002, 834 patients of age up to 18 years were registered in 10 centres and 713 received after central randomization the allocated risk-stratified treatment. After a median follow-up of 7 years, the event-free survival (EFS) was 67+/-3% on ALL-MB 91 (N=358) vs 68+/-3% on ALL-BFM 90m (N=355). The overall survival (OS) was 71+/-3% vs 74+/-2%, respectively. Anaemia, thrombocytopenia, agranulocytosis >10 days and hospitalization (median 35 vs 68 days) were lower on ALL-MB 91 (P<0.01, N=197). While EFS and OS were similar with both protocols, ALL-MB 91 significantly incurred fewer toxicity and resource requirements and, therefore, has been increasingly used across Russia.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Asparaginase / administration & dosage
  • Child
  • Child, Preschool
  • Cytarabine / administration & dosage
  • Daunorubicin / administration & dosage
  • Feasibility Studies
  • Female
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Methotrexate / administration & dosage
  • Palliative Care
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / drug therapy*
  • Prednisone / administration & dosage
  • Russia
  • Treatment Outcome
  • Vincristine / administration & dosage

Substances

  • Cytarabine
  • Vincristine
  • Asparaginase
  • Prednisone
  • Methotrexate
  • Daunorubicin