Intensive chemotherapy for childhood acute lymphoblastic leukemia: results of the randomized intercontinental trial ALL IC-BFM 2002

. 2014 Jan 20 ; 32 (3) : 174-84. [epub] 20131216

Jazyk angličtina Země Spojené státy americké Médium print-electronic

Typ dokumentu časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/pmid24344215

PURPOSE: From 2002 to 2007, the International Berlin-Frankfurt-Münster Study Group conducted a prospective randomized clinical trial (ALL IC-BFM 2002) for the management of childhood acute lymphoblastic leukemia (ALL) in 15 countries on three continents. The aim of this trial was to explore the impact of differential delayed intensification (DI) on outcome in all risk groups. PATIENTS AND METHODS: For this trial, 5,060 eligible patients were divided into three risk groups according to age, WBC, early treatment response, and unfavorable genetic aberrations. DI was randomized as follows: standard risk (SR), two 4-week intensive elements (protocol III) versus one 7-week protocol II; intermediate risk (IR), protocol III × 3 versus protocol II × 1; high risk (HR), protocol III × 3 versus either protocol II × 2 (Associazione Italiana Ematologia Oncologia Pediatrica [AIEOP] option), or 3 HR blocks plus single protocol II (Berlin-Frankfurt-Münster [BFM] option). RESULTS: At 5 years, the probabilities of event-free survival and survival were 74% (± 1%) and 82% (± 1%) for all 5,060 eligible patients, 81% and 90% for the SR (n = 1,564), 75% and 83% for the IR (n = 2,650), and 55% and 62% for the HR (n = 846) groups, respectively. No improvement was accomplished by more intense and/or prolonged DI. CONCLUSION: The ALL IC-BFM 2002 trial is a good example of international collaboration in pediatric oncology. A wide platform of countries able to run randomized studies in ALL has been established. Although the alternative DI did not improve outcome compared with standard treatment and the overall results are worse than those achieved by longer established leukemia groups, the national results have generally improved.

Jan Stary Jan Trka and Ondrej Hrusak Charles University and University Hospital Motol Prague; Yahia Jabali Regional Hospital Ceske Budejovice Czech Republic; Martin Zimmermann and Hansjörg Riehm Medical School Hannover Hannover; Martin Schrappe University Hospital Schleswig Holstein Kiel Germany; Myriam Campbell Roberto del Rio Hospital Universidad de Chile Santiago Chile; Luis Castillo Hospital Pereira Rossell Montevideo Uruguay; Eduardo Dibar Hospital Italiano de Buenos Aires Buenos Aires Argentina; Svetlana Donska Regional Oncologic Hospital Kiev Ukraine; Alejandro Gonzalez Institute of Hematology and Immunology La Habana Cuba; Shai Izraeli Sheba Medical Center of Israel Sackler School of Medicine Tel Aviv University Tel Hashomer; Batia Stark Schneider Children's Medical Center of Israel Sackler School of Medicine Tel Aviv University Petah Tikva Israel; Dragana Janic University Children's Hospital University of Belgrade Belgrade Serbia; Janez Jazbec University Children's Hospital Ljubljana Slovenia; Josip Konja University Hospital Centre Rebro Zagreb Croatia; Emilia Kaiserova University Children's Hospital Bratislava Slovakia; Jerzy Kowalczyk University of Lublin Lublin Poland; Gabor Kovacs and Edina Magyarosy Semmelweis University Budapest Hungary; Chi Kong Li Prince of Wales Hospital The Chinese University of Hong Kong Shatin Hong Kong Special Administrative Region People's Republic of China; Alexander Popa N N Blokhin Russian Cancer Research Center Moscow Russia; and Giuseppe Masera Ospedale S Gerardo University of Milano Bicocca Monza Italy

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