title: Allogeneic compared with autologous stem cell transplantation in the treatment of patients younger than 46 years with acute myeloid leukemia (AML) in first complete remission (CR1): an intention-to-treat analysis of the EORTC/GIMEMAAML-10 trial.
abstract: In the European Organization for Research and Treatment of Cancer Leukemia Group and Gruppo Italiano Malattie Ematologiche dell' Adulto (EORTC-LG/GIMEMA) acute myeloid leukemia (AML)-10 trial, patients in first complete remission (CR1) received a single intensive consolidation (IC) course. Subsequently, those patients younger than 46 years with an HLA-identical sibling donor were assigned to undergo allogeneic (allo) stem cell transplantation (SCT), and patients without such a donor were planned for autologous (auto) SCT. Between November 1993 and December 1999, of 1198 patients aged younger than 46 years, 822 achieved CR. The study group constituted 734 patients who received IC: 293 had a sibling donor and 441 did not. Allo-SCT and auto-SCT were performed in 68.9% and 55.8%, respectively. Cytogenetic determination was successfully performed in 446 patients. Risk groups were good (t(8;21), inv16), intermediate (NN or -Y only), and bad/very bad (all others). Median follow-up was 4 years; 289 patients relapsed, 66 died in CR1, and 293 died. Intention-to-treat analysis revealed that the 4-year disease-free survival (DFS) rate of patients with a donor versus those without a donor was 52.2% versus 42.2%, P =.044; hazard ratio = 0.80, 95% confidence interval (0.64, 0.995), the relapse incidence was 30.4% versus 52.5%, death in CR1 was 17.4% versus 5.3%, and the survival rate was 58.3% versus 50.8% (P =.18). The DFS rates in patients with and without a sibling donor were similar in patients with good/intermediate risk but were 43.4% and 18.4%, respectively, in patients with bad/very bad risk cytogenetics. In younger patients (15-35 years), the difference was more pronounced. The strategy to perform early allo-SCT led to better overall results than auto-SCT, especially for younger patients or those with bad/very bad risk cytogenetics.
authors.affiliation: European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium. ssu@eortc.be
authors.forename: Stefan
authors.initials: S
authors.lastname: Suciu
authors.forename: Franco
authors.initials: F
authors.lastname: Mandelli
authors.forename: Theo
authors.initials: T
authors.lastname: de Witte
authors.forename: Robert
authors.initials: R
authors.lastname: Zittoun
authors.forename: Eugenio
authors.initials: E
authors.lastname: Gallo
authors.forename: Boris
authors.initials: B
authors.lastname: Labar
authors.forename: Gennaro
authors.initials: G
authors.lastname: De Rosa
authors.forename: Amine
authors.initials: A
authors.lastname: Belhabri
authors.forename: Rosario
authors.initials: R
authors.lastname: Giustolisi
authors.forename: Richard
authors.initials: R
authors.lastname: Delarue
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Liso
authors.forename: Salvatore
authors.initials: S
authors.lastname: Mirto
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Leone
authors.forename: Jean-Henri
authors.initials: JH
authors.lastname: Bourhis
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Fioritoni
authors.forename: Ulrich
authors.initials: U
authors.lastname: Jehn
authors.forename: Sergio
authors.initials: S
authors.lastname: Amadori
authors.forename: Paola
authors.initials: P
authors.lastname: Fazi
authors.forename: Anne
authors.initials: A
authors.lastname: Hagemeijer
authors.forename: Roel
authors.initials: R
authors.lastname: Willemze
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D033581:Stem Cell Transplantation / Q000379:methods*; D009927:Tissue and Organ Procurement; D014182:Transplantation, Autologous; D014184:Transplantation, Homologous; D016896:Treatment Outcome