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

Submitted December 5, 2002
Accepted April 9, 2003
Allogeneic compared to autologous stem cell transplantation in the treatment of patients < 46 years old with acute myeloid leukemia (AML) in first complete remission (CR1): an intention to treat analysis of the EORTC/GIMEMA AML-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
EORTC Data Center, Brussels, Belgium
Department of Cellular Biotechnology and Hematology, University La Sapienza, Rome, Italy
Department of Hematology, St Radboud University Hospital, Nijmegen, The Netherlands
Department of Hematology, Hotel-Dieu, Paris, France
Department of Medicine, S. Giovanni Battista, Turin, Italy
Department of Hematology, University Hospital Rebro, Zagreb, Croatia (Hrvatska)
Department of Hematology, University Federico II Medical School, Naples, 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, 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, Rome, Italy
GIMEMA Data Center, Department of Cellular Biotechnology and Hematology, University La Sapienza, Rome, Italy
Center for Human Genetics, University of Leuven, Leuven, Belgium
Department of Hematology, Leiden University Medical Center, Leiden, The Netherlands
* Corresponding author; email: ssu{at}eortc.be.
In the EORTC-LG/GIMEMA AML-10 trial, patients (pts) in CR1 received a single intensive consolidation (IC) course. Subsequently, those < 46 years old with an HLA identical sibling donor were assigned to undergo allogeneic (allo) stem cell transplantation (SCT) and pts without such a donor were planned for autologous (auto) SCT. Between 11.1993 and 12.1999, out of 1198 pts aged < 46 years, 822 achieved CR. 734 pts, constituting the study group, received IC: 293 had a sibling donor and 441 had not. Allo-SCT and auto-SCT was performed in 68.9% and 55.8%, respectively. Cytogenetics was successfully performed in 446 pts. Risk groups were: good (t(8;21), inv(16)), intermediate (NN or -Y only), bad/very bad (all others). Median follow-up was 4 years; 289 pts relapsed, 66 died in CR1, and 293 died. Intention-to-treat analysis revealed that the 4-year disease-free survival (DFS) rate of pts with a donor vs of those without a donor was 52.2% vs 42.2%, p=0.044; hazard ratio=0.80, 95% confidence interval (0.64 , 0.995), the relapse incidence was 30.4% vs 52.5%, death in CR1 was 17.4% vs 5.3%, and the survival rate was 58.3% vs 50.8% (p=0.18). The DFS rates in pts with and without a sibling donor were similar in pts with good/intermediate risk, but 43.4% and 18.4%, respectively, in pts with bad/very bad risk cytogenetics. In younger patients (15-35 yrs), 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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