Format

Send to

Choose Destination
Haematologica. 2014 Jul;99(7):1220-7. doi: 10.3324/haematol.2014.103507. Epub 2014 Apr 11.

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.

Author information

1
Institute of Hematology and Oncology Pediatrics, Hospices Civils de Lyon, University Claude Bernard Lyon I, France carine.halfon-domenech@chu-lyon.fr.
2
EORTC Headquarters, Brussels, Belgium.
3
Department of Pediatric Hematology-Oncology, Ghent University Hospital, Belgium.
4
Department of Pediatric Hematology-Oncology, CHR, Lille, France.
5
Department of Hematology, Children's Hospital, Toulouse, France.
6
Department of Pediatrics, University Hospital Gasthuisberg, Leuven, Belgium.
7
Department of Hemato-Oncology, HUDERF Brussels, Belgium.
8
Department of Hemato-Oncology, A Villeneuve Hospital, Montpellier, France.
9
Department of Hematology, Hautepierre, Strasbourg, France.
10
Department of Hematology, Robert Debré Hospital, Paris, France.
11
Department of Hematology, American Hospital, Reims, France.
12
Department of Hemato-Oncology, CHRU, Besançon, France.
13
Department of Pediatrics, CHR La Tronche, Grenoble, France.
14
Department of Hematology, J Bernard Hospital, Poitiers, France.
15
Department of Pediatrics, CHC-Esperance, Montegnée, Belgium.
16
Department of Hematology, Edouard Herriot Hospital, Hospices Civils de Lyon, France.
17
Department of Genetics, Robert-Debré Hospital, Paris, France.
18
Institute of Hematology and Oncology Pediatrics, Hospices Civils de Lyon, University Claude Bernard Lyon I, France.

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.

PMID:
24727815
PMCID:
PMC4077084
DOI:
10.3324/haematol.2014.103507
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for HighWire Icon for PubMed Central
Loading ...
Support Center