PURPOSE: The International Berlin-Frankfurt-Münster (BFM) study group conducted a study on pediatric acute lymphoblastic leukemia (ALL). Minimal residual disease (MRD) was assessed using flow cytometry (FCM), and the impact of early intensification and methotrexate (MTX) dose on survival was evaluated. PATIENTS AND METHODS: We included 6,187 patients younger than 19 years. MRD by FCM refined the risk group definition previously used in the ALL intercontinental-BFM 2002 study on the basis of age, WBC count, unfavorable genetic aberrations, and treatment response measured morphologically. Patients at intermediate risk (IR) and high risk (HR) were randomly assigned to protocol augmented protocol I phase B (IB) versus IB regimen. MTX doses of 2 versus 5 g/m2 every 2 weeks, four times, were evaluated in precursor B-cell-ALL (pcB-ALL) IR. RESULTS: The 5-year event-free survival (EFS ± SE) and overall survival (OS ± SE) rates were 75.2% ± 0.6% and 82.6% ± 0.5%, respectively. Their values in risk groups were standard risk (n = 624), 90.7% ± 1.4% and 94.7% ± 1.1%; IR (n = 4,111), 77.9% ± 0.7% and 85.7% ± 0.6%; and HR (n = 1,452), 60.8% ± 1.5% and 68.4% ± 1.4%, respectively. MRD by FCM was available in 82.6% of cases. The 5-year EFS rates in patients randomly assigned to protocol IB (n = 1,669) and augmented IB (n = 1,620) were 73.6% ± 1.2% and 72.8% ± 1.2%, respectively (P = .55), while those in patients receiving MTX doses of 2 g/m2 (n = 1,056) and MTX 5 g/m2 (n = 1,027) were 78.8% ± 1.4% and 78.9% ± 1.4%, respectively (P = .84). CONCLUSION: The MRDs were successfully assessed using FCM. An MTX dose of 2 g/m2 was effective in preventing relapse in non-HR pcB-ALL. Augmented IB showed no advantages over the standard IB.[Media: see text].

2nd Department of Pediatrics Semmelweis University Budapest Hungary

Argentine Group for the Treatment of Acute Leukemia GATLA Buenos Aires Argentina

Centro Tettamanti Fondazione IRCCS San Gerardo dei Tintori Monza Italy

Chilean National Pediatric Oncology Group PINDA Hospital Roberto del Rio Universidad de Chile Santiago Chile

Deceased

Department of Interventional Epidemiology Faculty of Public Health University of Debrecen Debrecen Hungary

Department of Laboratory Medicine Faculty of Medicine University of Debrecen Debrecen Hungary

Department of Pediatric and Adolescent Medicine University Medical Center Schleswig Holstein Kiel Germany

Department of Pediatric Hematology and Oncology 2nd Faculty of Medicine Charles University and University Hospital Motol Prague Czech Republic

Department of Pediatric Hematology and Oncology Hannover Medical School Hannover Germany

Department of Pediatric Hematology and Oncology Hospital Roberto del Rio Universidad de Chile Chilean National Pediatric Oncology Group PINDA Santiago Chile

Department of Pediatric Hematology and Oncology National Institute of Children's Diseases and Medical School Comenius University Bratislava Slovakia

Department of Pediatric Hematology and Oncology Zabrze Medical University of Silesia Katowice Poland

Department of Pediatric Hematology Oncology and Transplantology Medical University of Lublin Lublin Poland

Department of Pediatrics Division of Pediatric Hematology and Oncology Faculty of Medicine University of Debrecen Debrecen Hungary

Hematology and Oncology Department Hospital de Pediatría Prof Dr Juan P Garrahan SAHOP Buenos Aires Argentina

Hospital del Salvador Universidad de Chile Santiago Chile

Immunology and Rheumatology Department Hospital de Pediatría Prof Dr Juan P Garrahan Buenos Aires Argentina

Institute of Hematology and Immunology Pediatric Clinic Havana Cuba

Mother and Child Health Care Institute of Serbia Dr Vukan Cupic Faculty of Medicine Belgrade Serbia

Mother and Child's Health Department Division of Pediatric Hematology Oncology and Stem Cell Transplant University of Padova Padova Veneto Italy

Pediatric and Adolescent Oncology Clinic Children's Hospital MITERA Athens Greece

Pediatric Hemato Oncology Department Hospital Pereira Rossell Pérez Scremini Foundation Montevideo Uruguay

Pediatric Hematology and Oncology Department University Hospital Tsaritsa Johanna ISUL Sofia Bulgaria

Pediatric Oncology and Hematology Research Institute of N N Blokhin National Cancer Research Center Center Moscow Russia

School of Medicine Division of Pediatric Hematology and Oncology University Hospital Center University of Zagreb Zagreb Croatia

St Anna Children's Cancer Research Institute Vienna Austria

University Medical Center Ljubljana Ljubljana Slovenia

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EudraCT 2010-019722-13