Journal Article

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

Chipsanova, N, Karachunskiy, A, Lebedev, V, Herold, R, Maschan, A, Miakova, N, Varfolomeeva, S, Rumjanzew, A, Timakow, A, Timofeeva, V, Henze, G, Dudkin, S, Bajdun, L, Fechina, L, Mahortih, T, von Stackelberg, A, Roumiantseva, J, Shamardina, A

2008

Overview

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.

• Publisher: Nature Publishing Group UK,Nature Publishing Group
• Subject: Acute lymphoblastic leukemia / Acute lymphocytic leukemia / Adolescent / Anemia / Anthracycline / Antineoplastic Combined Chemotherapy Protocols - therapeutic use / Aplasia / Asparaginase - administration & dosage / Blood transfusion / Blood transfusions / Bone marrow / Cancer Research / Care and treatment / Chemotherapy / Child / Child, Preschool / Childhood / Children / Critical Care Medicine / Cytarabine - administration & dosage / Daunorubicin - administration & dosage / Dexamethasone / Dosage and administration / Feasibility Studies / Female / Genetic aspects / Hematology / Hospitalization / Humans / Immunology / Infant / Infant, Newborn / Intensive / Internal Medicine / Leukemia / Male / Medical prognosis / Medicine / Medicine & Public Health / Methotrexate - administration & dosage / Neutropenia / Oncology / original-article / Palliative Care / Patients / Pediatrics / Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy / Prednisone - administration & dosage / Radiation / Radiation therapy / Randomization / Risk allocation / Risk groups / Russia / Survival / Thrombocytopenia / Toxicity / Treatment Outcome / Vincristine - administration & dosage