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Prepublished online as a Blood First Edition Paper on April 24, 2003; DOI 10.1182/blood-2002-12-3714.

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Blood, 15 August 2003, Vol. 102, No. 4, pp. 1232-1240

CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS

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

Stefan Suciu, Franco Mandelli, Theo de Witte, Robert Zittoun, Eugenio Gallo, Boris Labar, Gennaro De Rosa, Amine Belhabri, Rosario Giustolisi, Richard Delarue, Vincenzo Liso, Salvatore Mirto, Giuseppe Leone, Jean-Henri Bourhis, Giuseppe Fioritoni, Ulrich Jehn, Sergio Amadori, Paola Fazi, Anne Hagemeijer, and Roel Willemze, the EORTC and GIMEMA Leukemia Groups

From the European Organization for Research and Treatment of Cancer (EORTC) Data Center, Brussels, Belgium; Department of Cellular Biotechnology and Hematology, University La Sapienza, Roma, Italy; Department of Hematology, St Radboud University Hospital, Nijmegen, The Netherlands; Department of Hematology, Hotel-Dieu, Paris, France; Department of Medicine, Hospital S. Giovanni Battista, Torino, Italy; Department of Hematology, University Hospital Rebro, Zagreb, Croatia; Department of Hematology, University Federico II Medical School, Napoli, Italy; Department of Hematology, Hospital Edouard Herriot, Lyon, France; Department of Hematology, Hospital Ferrarotto, Catania, Italy; Department of Hematology, Hospital Necker, Paris, France; Department of Hematology, University degli Study di Bari, Bari, Italy; Department of Hematology, Hospital Cervello, Palermo, Italy; Department of Hematology, Catholic University, Rome Italy; Department of Hematology, Institut Gustave Roussy, Villejuif, France; Department of Hematology, Civil Hospital, Pescara, Italy; Department of Hematology, Klinikum Grosshadern Ludwig-Maximilians, Muenchen, Germany; Department of Hematology, University Tor Vergata, Roma, Italy; Gruppo Italiano Malattie Ematologiche dell' Adulto (GIMEMA) Data Center, Department of Cellular Biotechnology and Hematology, University La Sapienza, Roma, Italy; Center for Human Genetics, University of Leuven, Leuven, Belgium; Department of Hematology, and Leiden University Medical Center, Leiden, the Netherlands.

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.


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