Pediatric acute lymphoblastic leukemia: multicenter study of the treatment by the protocol ALL IC-BFM 2002

Abstract

Background. Recovery of children with acute lymphoblastic leukemia (ALL) was one of the most significant achievements of clinical oncohematology of XX century. Success in the treatment of ALL became possible due to comprehensive (clinical, morphoimmunological, cytogenetic) diagnostics and the development of differentiated, risk-adapted treatment protocols. The German group BFM (Berlin–Frankfurt–Munster) became a pioneer in creating effective treatment programs for children with ALL. Its new principles and approaches in treatment allow the vast majority of patients to be cured.The aim of the study – presentation of the treatment results of children with ALL based on the ALL IC-BFM 2002 protocol as part of a multicenter long standing study.Materials and methods. There were 592 patients with a newly diagnosed ALL in the study . The average age of patients was 10.5 years (from 4 months to 21 years). Treatment was carried out according to the ALL IC-BFM 2002 protocol in 11 clinics from 01.11.2003 to 16.05.2022. The overall (OS), relapse-free (RFS) and event-free (EFS) survivals of patients were estimated on 01.07.2022.Results. Complete clinical and hematological remission was achieved by the 33 day of therapy in 582 (98.3 %) cases. 10-year OS was 90.4 ± 1.5 %, RFS – 83.9 ± 1.9 % EFS – 82.4 ± 1.9 %. The analysis of survival of ALL patients in prognostic risk groups showed that 10-year OS in the standard risk group was 92.8 ± 1.7 %, RFS – 86 ± 2.2 % and EFS – 84.3 ± 2.2 %. Among the patients of the intermediate risk group the OS, RFS and EFS were 94.6 ± 2.6 %, 82.2 ± 5 % and 81.7 ± 5 %, respectively. The prognosis of ALL patients from the high-risk group turned out to be the least favorable: OS was 69.5 ± 8.7 %, RFS – 62 ± 9.4 % and EFS – 60.3 ± 9.3 %.Conclusion. Based on the results of a multicenter study the ALL IC-BFM 2002 protocol showed high efficiency with the possibility of achieving a 10-year OS of 90.4 ± 1.5 %. This protocol turned out to be reproducible both in federal and regional clinics with high rates of long-term patients survival. This fact allows including it in the clinical recommendations of the Ministry of Health of Russia.