1. ¹Department of Pediatrics, Hautepierre, Strasbourg, France
2. ²EORTC Data Center, Brussels, Belgium
3. ³Department of Pediatrics, Academisch Ziekenhuis-VUB, Brussels, Belgium
4. ⁴Department of Hemato-Immunology, Robert Debré Hospital, Paris, France
5. ⁵Department of Immuno-Hemato-Pediatrics, Debrousse Hospital, Lyon, France
6. ⁶Department of Pediatric Hemato-Oncology, Universitair Kinderziekenhuis, Gent, Belgium
7. ⁷Department of Onco-Hematology, Arnaud de Villeneuve Hospital, Montpellier, France
8. ⁸Department of Pediatric Hematology, Saint-Jacques Hospital, Besançon, France
9. ⁹Department of Pediatrics, CHRU, Caen, France
10. ¹⁰Department of Hemato-Oncology, HUDE, Brussels, Belgium
11. ¹¹Department of Pediatric Hemato-Oncology, UZ Gasthuisberg, Leuven, Belgique
12. ¹²Department of Hematology, CHR de la Citadelle, Liège, Belgium
13. ¹³Department of Hemato-Oncology, Antoine Lacassagne Center, Nice, France
14. ¹⁴Department of Pediatric Hemato-Oncology, CHRU, Angers, France
15. ¹⁵Department of Pediatric Hemato-Oncology, Escolar San Joao Hospital, Porto, Portugal
16. ¹⁶Department of Pediatric Hematology, American Hospital, Reims, France

Correspondence: Dr C Behar, Department of Pediatric Hematology, American Hospital 45, rue Cognacq-Jay, F-51092 Reims, France. Fax: +33 326784096; E-mail: cbehar@chu-reims.fr

¹⁷The first two authors contributed equally to this work

Deceased

Received 8 December 2004; Accepted 26 July 2005; Published online 1 September 2005.

Abstract

The first EORTC (European Organization of Research and Treatment of Cancer) acute myeloblastic leukemia (AML) pilot study (58872) was conducted between January 1988 and December 1991. Out of 108 patients, 78% achieved complete remission (CR), and event-free survival (EFS) and survival rates (s.e., %) at 7 years were 40 (5) and 51% (6%), respectively. It indicated that mitoxantrone could be substituted for conventional anthracyclines in the treatment of childhood AML without inducing cardiotoxicity. The aim of the next EORTC 58921 trial was to compare the efficacy and toxicity of idarubicin vs mitoxantrone in initial chemotherapy courses, further therapy consisting of allogeneic bone marrow transplantation (alloBMT) in patients with an HLA-compatible sibling donor or chemotherapy in patients without a donor. Out of 177 patients, recruited between October 1992 and December 2002, 81% reached CR. Overall 7-year EFS and survival rates were 49 (4) and 62% (4%), respectively. Out of 145 patients who received the first intensification, 39 had a sibling donor. In patients with or without a donor, the 7-year disease-free survival (DFS) rate was 63 (8) and 57% (5%) and the 7-year survival rate was 78 (7) and 65% (5%), respectively. Patients with favorable, intermediate and unfavorable cytogenetic features had a 5-year EFS rate of 57, 45 and 45% and a 5-year survival rate of 89, 67 and 53%, respectively.