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

• Published in: Haematologica (Roma) Vol. 99; no. 7; pp. 1220 - 1227
• Main 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
• Format: Journal Article
• Language: English
• Published: Italy Ferrata Storti Foundation 01.07.2014
• Subjects: Adolescent; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Child; Child, Preschool; Dexamethasone - administration & dosage; Female; Humans; Immunophenotyping; Induction Chemotherapy; Infant; Infant, Newborn; Male; Precursor Cell Lymphoblastic Leukemia-Lymphoma - diagnosis; Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy; Precursor Cell Lymphoblastic Leukemia-Lymphoma - mortality; Prednisolone - administration & dosage; Risk Factors; Treatment Outcome
• ISSN: 0390-6078; 1592-8721
• DOI: 10.3324/haematol.2014.103507

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.