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Blood, 1 May 2007, Vol. 109, No. 9, pp. 3658-3666.
Prepublished online as a Blood First Edition Paper on January 9, 2007; DOI 10.1182/blood-2006-06-025627.


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CLINICAL TRIALS AND OBSERVATIONS

Results of a HOVON/SAKK donor versus no-donor analysis of myeloablative HLA-identical sibling stem cell transplantation in first remission acute myeloid leukemia in young and middle-aged adults: benefits for whom?

Jan J. Cornelissen1, Wim L. J. van Putten1, Leo F. Verdonck2, Matthias Theobald3, Emanuel Jacky4, Simon M. G. Daenen5, Marinus van Marwijk Kooy6, Pierre Wijermans7, Harry Schouten8, Peter C. Huijgens9, Hans van der Lelie10, Martin Fey11, Augustin Ferrant12, Johan Maertens13, Alois Gratwohl14, and Bob Lowenberg1

1 Erasmus University Medical Center, Rotterdam, The Netherlands; 2 University Medical Center Utrecht, Utrecht, The Netherlands; 3 Johannes Gutenberg University, Mainz, Germany; 4 University Hospital Zurich, Zurich, Switzerland; 5 University Medical Center Groningen, Groningen, The Netherlands; 6 Isala Klinieken, Zwolle, The Netherlands; 7 Haga Hospital, Den Haag, The Netherlands; 8 University Hospital Maastricht, Maastricht, The Netherlands; 9 Free University Medical Center, Amsterdam, The Netherlands; 10 Amsterdam Medical Center, Amsterdam, The Netherlands; 11 University Hospital, Bern, Switzerland; 12 Cliniques Universitaires Saint-Luc, Brussels, Belgium; 13 University Hospital Gasthuisberg, Leuven, Belgium; 14 Kantonsspital, Basel, Switzerland

The Dutch-Belgian Hemato-Oncology Cooperative Group and the Swiss Group for Clinical Cancer Research (HOVON-SAKK) collaborative study group evaluated outcome of patients (pts) with acute myeloid leukemia (AML) in first remission (CR1) entered in 3 consecutive studies according to a donor versus no-donor comparison. Between 1987 and 2004, 2287 pts were entered in these studies of whom 1032 pts (45%) without FAB M3 or t(15;17) were in CR1 after 2 cycles of chemotherapy, received consolidation treatment, and were younger than 55 years of age and therefore eligible for allogeneic hematopoietic stem cell transplantation (allo-SCT). An HLA-identical sibling donor was available for 326 pts (32%), whereas 599 pts (58%) lacked such a donor, and information was not available in 107 pts. Compliance with allo-SCT was 82% (268 of 326). Cumulative incidences of relapse were, respectively, 32% versus 59% for pts with versus those without a donor (P < .001). Despite more treatment-related mortality (TRM) in the donor group (21% versus 4%, P < .001), disease-free survival (DFS) appeared significantly better in the donor group (48% ± 3% versus 37% ± 2% in the no-donor group, P < .001). Following risk-group analysis, DFS was significantly better for pts with a donor and an intermediate- (P = .01) or poor-risk profile (P = .003) and also better in pts younger than 40 years of age (P < .001). We evaluated our results and those of the previous MRC, BGMT, and EORTC studies in a meta-analysis, which revealed a significant benefit of 12% in overall survival (OS) by donor availability for all patients with AML in CR1 without a favorable cytogenetic profile.


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