Title: Dexamethasone (6 mg/m2/day) and prednisolone (60 mg/m2/day) were equally effective as induction therapy for childhood acute lymphoblastic leukemia in the EORTC CLG 58951 randomized trial
Authors: Domenech, Carine ×
Suciu, Stefan
De Moerloose, Barbara
Mazingue, Françoise
Plat, Geneviève
Ferster, Alina
Uyttebroeck, Anne
Sirvent, Nicolas
Lutz, Patrick
Yakouben, Karima
Munzer, Martine
Röhrlich, Pierre
Plantaz, Dominique
Millot, Frederic
Philippet, Pierre
Dastugue, Nicole
Girard, Sandrine
Cavé, Hélène
Benoit, Yves
Bertrandfor, Yves
Children's Leukemia Group (CLG) of European Organisation for Research and Treatment of Cancer (EORTC) #
Issue Date: Jul-2014
Publisher: Il Pensiero Scientifico
Series Title: Haematologica vol:99 issue:7 pages:1220-7
Article number: 10.3324/haematol.2014.103507
Abstract: Dexamethasone could be more effective than prednisolone at similar anti-inflammatory doses in the treatment of childhood acute lymphoblastic leukemia. In order to check if this "superiority" of dexamethasone might be dose-dependent, we conducted a randomized phase III trial comparing dexamethasone (6 mg/m(2)/day) to prednisolone (60 mg/m(2)/day) in induction therapy. All newly diagnosed children and adolescents with acute lymphoblastic leukemia in the 58951 EORTC trial were randomized on prephase day 1 or day 8. The main endpoint was event-free survival; secondary endpoints were overall survival and toxicity. A total of 1947 patients with acute lymphoblastic leukemia were randomized. At a median follow-up of 6.9 years, the 8-year event-free survival rate was 81.5% in the dexamethasone arm and 81.2% in the prednisolone arm; the 8-year overall survival rates were 87.2% and 89.0% respectively. The 8-year incidences of isolated or combined central nervous system relapse were 2.9% and 4.5% in the dexamethasone and prednisolone arms, respectively. The incidence of grade 3-4 toxicities during induction and the frequency of osteonecrosis were similar in the two arms. In conclusion, dexamethasone and prednisolone, used respectively at the doses of 6 and 60 mg/m(2)/day during induction, were equally effective and had a similar toxicity profile. Dexamethasone decreased the 8-year central nervous system relapse incidence by 1.6%. This trial was registered at as #NCT00003728.
ISSN: 0390-6078
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Organ Systems (+)
× corresponding author
# (joint) last author

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