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.
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 www.clinicaltrials.gov as #NCT00003728.
authors.affiliation: Institute of Hematology and Oncology Pediatrics, Hospices Civils de Lyon, University Claude Bernard Lyon I, France carine.halfon-domenech@chu-lyon.fr.
authors.forename: Carine
authors.initials: C
authors.lastname: Domenech
authors.affiliation: EORTC Headquarters, Brussels, Belgium.
authors.forename: Stefan
authors.initials: S
authors.lastname: Suciu
authors.affiliation: Department of Pediatric Hematology-Oncology, Ghent University Hospital, Belgium.
authors.forename: Barbara
authors.initials: B
authors.lastname: De Moerloose
authors.affiliation: Department of Pediatric Hematology-Oncology, CHR, Lille, France.
authors.forename: Françoise
authors.initials: F
authors.lastname: Mazingue
authors.affiliation: Department of Hematology, Children's Hospital, Toulouse, France.
authors.forename: Geneviève
authors.initials: G
authors.lastname: Plat
authors.affiliation: Department of Pediatrics, University Hospital Gasthuisberg, Leuven, Belgium.
authors.forename: Alina
authors.initials: A
authors.lastname: Ferster
authors.affiliation: Department of Hemato-Oncology, HUDERF Brussels, Belgium.
authors.forename: Anne
authors.initials: A
authors.lastname: Uyttebroeck
authors.affiliation: Department of Hemato-Oncology, A Villeneuve Hospital, Montpellier, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Sirvent
authors.affiliation: Department of Hematology, Hautepierre, Strasbourg, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Lutz
authors.affiliation: Department of Hematology, Robert Debré Hospital, Paris, France.
authors.forename: Karima
authors.initials: K
authors.lastname: Yakouben
authors.affiliation: Department of Hematology, American Hospital, Reims, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Munzer
authors.affiliation: Department of Hemato-Oncology, CHRU, Besançon, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Röhrlich
authors.affiliation: Department of Pediatrics, CHR La Tronche, Grenoble, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Plantaz
authors.affiliation: Department of Hematology, J Bernard Hospital, Poitiers, France.
authors.forename: Frederic
authors.initials: F
authors.lastname: Millot
authors.affiliation: Department of Pediatrics, CHC-Esperance, Montegnée, Belgium.
authors.forename: Pierre
authors.initials: P
authors.lastname: Philippet
authors.affiliation: Department of Hematology, Children's Hospital, Toulouse, France.
authors.forename: Nicole
authors.initials: N
authors.lastname: Dastugue
authors.affiliation: Department of Hematology, Edouard Herriot Hospital, Hospices Civils de Lyon, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Girard
authors.affiliation: Department of Genetics, Robert-Debré Hospital, Paris, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Cavé
authors.affiliation: Department of Pediatric Hematology-Oncology, Ghent University Hospital, Belgium.
authors.forename: Yves
authors.initials: Y
authors.lastname: Benoit
authors.affiliation: Institute of Hematology and Oncology Pediatrics, Hospices Civils de Lyon, University Claude Bernard Lyon I, France.
authors.forename: Yves
authors.initials: Y
authors.lastname: Bertrandfor
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006801:Humans; D016130:Immunophenotyping; D060828:Induction Chemotherapy; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D011239:Prednisolone / Q000008:administration & dosage; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D003907:Dexamethasone; D011239:Prednisolone
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