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Risk-adjusted therapy of acute lymphoblastic leukemia can decrease treatment burden and improve survival: treatment results of 2169 unselected pediatric and adolescent patients enrolled in the trial ALL-BFM 95

2008; Elsevier BV; Volume: 111; Issue: 9 Linguagem: Inglês

10.1182/blood-2007-09-112920

1528-0020

Anja Möricke, Alfred Reiter, Martin Zimmermann, Helmut Gadner, Martin Stanulla, Michael Dördelmann, Lutz Löning, Rita Beier, Wolfgang Ludwig, Richard Ratei, Jochen Harbott, Joachim Boos, Georg Mann, Felix Niggli, A Feldges, Günter Henze, Karl Welte, Jörn‐Dirk Beck, Thomas Klingebiel, Charlotte M. Niemeyer, F Zintl, U. Bode, Christian Urban, H. Wehinger, D. Niethammer, Hansjörg Riehm, Martin Schrappe,

Neuroblastoma Research and Treatments

Abstract The trial ALL-BFM 95 for treatment of childhood acute lymphoblastic leukemia was designed to reduce acute and long-term toxicity in selected patient groups with favorable prognosis and to improve outcome in poor-risk groups by treatment intensification. These aims were pursued through a stratification strategy using white blood cell count, age, immunophenotype, treatment response, and unfavorable genetic aberrations providing an excellent discrimination of risk groups. Estimated 6-year event-free survival (6y-pEFS) for all 2169 patients was 79.6% (± 0.9%). The large standard-risk (SR) group (35% of patients) achieved an excellent 6y-EFS of 89.5% (± 1.1%) despite significant reduction of anthracyclines. In the medium-risk (MR) group (53% of patients), 6y-pEFS was 79.7% (± 1.2%); no improvement was accomplished by the randomized use of additional intermediate-dose cytarabine after consolidation. Omission of preventive cranial irradiation in non–T-ALL MR patients was possible without significant reduction of EFS, although the incidence of central nervous system relapses increased. In the high-risk (HR) group (12% of patients), intensification of consolidation/reinduction treatment led to considerable improvement over the previous ALL-BFM trials yielding a 6y-pEFS of 49.2% (± 3.2%). Compared without previous trial ALL-BFM 90, consistently favorable results in non-HR patients were achieved with significant treatment reduction in the majority of these patients.