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

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.