Results of the first randomized multicentre trial on childhood acute lymphoblastic leukaemia in Russia
| Autor: | Julia Roumiantseva, Shamardina Av, Lebedev Vv, Ralf Herold, Alexander Karachunskiy, T Mahortih, Larisa Fechina, Dudkin Sa, A Rumjanzew, A Timakow, Natalia Miakova, Timofeeva Vn, A. A. Maschan, Günter Henze, L Bajdun, S. Varfolomeeva, A von Stackelberg, N Chipsanova |
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| Rok vydání: | 2008 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Pediatrics Randomization Adolescent Anthracycline medicine.medical_treatment Russia Internal medicine Acute lymphocytic leukemia Antineoplastic Combined Chemotherapy Protocols medicine Asparaginase Humans Child Chemotherapy Hematology business.industry Daunorubicin Palliative Care Cytarabine Infant Newborn Infant Precursor Cell Lymphoblastic Leukemia-Lymphoma medicine.disease Surgery Radiation therapy Clinical trial Methotrexate Treatment Outcome Oncology El Niño Vincristine Child Preschool Feasibility Studies Prednisone Female business |
| Zdroj: | Leukemia. 22:1144-1153 |
| ISSN: | 1476-5551 0887-6924 |
| Popis: | 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, agranulocytosis10 days and hospitalization (median 35 vs 68 days) were lower on ALL-MB 91 (P0.01, 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. |
| Databáze: | OpenAIRE |
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