title: Results of 58872 and 58921 trials in acute myeloblastic leukemia and relative value of chemotherapy vs allogeneic bone marrow transplantation in first complete remission: the EORTC Children Leukemia Group report.
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.
authors.affiliation: Department of Pediatrics, Hautepierre, Strasbourg, France.
authors.forename: N
authors.initials: N
authors.lastname: Entz-Werle
authors.forename: S
authors.initials: S
authors.lastname: Suciu
authors.forename: J
authors.initials: J
authors.lastname: van der Werff ten Bosch
authors.forename: E
authors.initials: E
authors.lastname: Vilmer
authors.forename: Y
authors.initials: Y
authors.lastname: Bertrand
authors.forename: Y
authors.initials: Y
authors.lastname: Benoit
authors.forename: G
authors.initials: G
authors.lastname: Margueritte
authors.forename: E
authors.initials: E
authors.lastname: Plouvier
authors.forename: P
authors.initials: P
authors.lastname: Boutard
authors.forename: E
authors.initials: E
authors.lastname: Vandecruys
authors.forename: A
authors.initials: A
authors.lastname: Ferster
authors.forename: P
authors.initials: P
authors.lastname: Lutz
authors.forename: A
authors.initials: A
authors.lastname: Uyttebroeck
authors.forename: C
authors.initials: C
authors.lastname: Hoyoux
authors.forename: A
authors.initials: A
authors.lastname: Thyss
authors.forename: X
authors.initials: X
authors.lastname: Rialland
authors.forename: L
authors.initials: L
authors.lastname: Norton
authors.forename: M-P
authors.initials: MP
authors.lastname: Pages
authors.forename: N
authors.initials: N
authors.lastname: Philippe
authors.forename: J
authors.initials: J
authors.lastname: Otten
authors.forename: C
authors.initials: C
authors.lastname: Behar
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D024221:Antineoplastic Protocols / Q000592:standards*; D016026:Bone Marrow Transplantation; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015255:Idarubicin / Q000627:therapeutic use; D007223:Infant; D007231:Infant, Newborn; D015470:Leukemia, Myeloid, Acute / Q000401:mortality / Q000628:therapy*; D008297:Male; D008942:Mitoxantrone / Q000627:therapeutic use; D012074:Remission Induction; D015996:Survival Rate; D014184:Transplantation, Homologous
chemical_list: D008942:Mitoxantrone; D015255:Idarubicin