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Title: Improved outcome with pulses of vincristine and corticosteroids in continuation therapy of children with average risk acute lymphoblastic leukemia (ALL) and lymphoblastic non-Hodgkin lymphoma (NHL): report of the EORTC randomized phase 3 trial 58951
Authors: De Moerloose, Barbara ×
Suciu, Stefan
Bertrand, Yves
Mazingue, Françoise
Robert, Alain
Uyttebroeck, Anne
Yakouben, Karima
Ferster, Alice
Margueritte, Geneviève
Lutz, Patrick
Munzer, Martine
Sirvent, Nicolas
Norton, Lucilia
Boutard, Patrick
Plantaz, Dominique
Millot, Frederic
Philippet, Pierre
Baila, Liliana
Benoit, Yves
Otten, Jacques
Children's Leukemia Group of the European Organisation for Research and Treatment of Cancer (EORTC) #
Issue Date: Jul-2010
Publisher: W.B. Saunders
Series Title: Blood vol:116 issue:1 pages:36-44
Abstract: The European Organisation for Research and Treatment of Cancer 58951 trial for children with acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma (NHL) addressed 3 randomized questions, including the evaluation of dexamethasone (DEX) versus prednisolone (PRED) in induction and, for average-risk patients, the evaluation of vincristine and corticosteroid pulses during continuation therapy. The corticosteroid used in the pulses was that assigned at induction. Overall, 411 patients were randomly assigned: 202 initially randomly assigned to PRED (60 mg/m(2)/d), 201 to DEX (6 mg/m(2)/d), and 8 nonrandomly assigned to PRED. At a median follow-up of 6.3 years, there were 19 versus 34 events for pulses versus no pulses; 6-year disease-free survival (DFS) rate was 90.6% (standard error [SE], 2.1%) and 82.8% (SE, 2.8%), respectively (hazard ratio [HR] = 0.54; 95% confidence interval, 0.31-0.94; P = .027). The effect of pulses was similar in the PRED (HR = 0.56) and DEX groups (HR = 0.59) but more pronounced in girls (HR = 0.24) than in boys (HR = 0.71). Grade 3 to 4 hepatic toxicity was 30% versus 40% in pulses versus no pulses group and grade 2 to 3 osteonecrosis was 4.4% versus 2%. For average-risk patients treated according to Berlin-Frankfurt-Muenster-based protocols, pulses should become a standard component of therapy.
URI: 
ISSN: 0006-4971
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Pediatric Hematology & Oncology Section (-)
Section Child - Miscellaneous (-)
× corresponding author
# (joint) last author

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