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J Clin Oncol. 2017 Jul 1;35(19):2157-2164. doi: 10.1200/JCO.2016.70.7349. Epub 2017 May 2.

Dose-Reduced Versus Standard Conditioning Followed by Allogeneic Stem-Cell Transplantation for Patients With Myelodysplastic Syndrome: A Prospective Randomized Phase III Study of the EBMT (RICMAC Trial).

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Nicolaus Kröger, University Medical Center Hamburg-Eppendorf, Hamburg; Georg-Nikolaus Franke, University Hospital Leipzig, Leipzig; Uwe Platzbecker, University Hospital Dresden, Dresden; Kai Hübel and Christof Scheid, University of Cologne, Cologne; Thomas Weber, University Hospital Halle (Saale), Martin-Luther-University Halle-Wittenberg, Halle; Matthias Stelljes, University of Münster, Münster; Peter Dreger, University of Heidelberg, Heidelberg; Andreas Günther, University Hospital Schleswig Holstein Campus Kiel, Kiel; Wolfgang Bethge, University Hospital Tübingen, Tübingen; Guido Kobbe, Heinrich Heine University, Düsseldorf, Germany; Simona Iacobelli, Università Tor Vergata, Rome; Giorgio Lambertenghi Deliliers and Francesco Onida, Fondazione IRCC Ca' Granda Ospedale Maggiore Policlinico, University of Milano, Milan; Massimo Pini, Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo, Alessandria; Stefano Guidi, Azienda Ospedaliera Universitaria Careggi, Florence, Italy; Ruzena Uddin, Guy's Hospital, London, United Kingdom; Marie Robin, Hôpital Saint Louis, Assistance Publique Hôpitaux Paris, France; Boris Afanasyev, SPB Pavlov Medical University, St Petersburg, Russia; Dominik Heim, University Hospital Basel, Basel Switzerland; Liisa Volin, Helsinki University Hospital, Helsiniki, Finland; Xavier Poiré, Cliniques Universitaires St-Luc, Brussels, Belgium; Marleen van Os, European Group of Blood and Marrow Transplantation Clinical Trials Office; Ronald Brand, Leiden University Medical Center, Leiden; and Theo de Witte, Radboud University Medical Center, Nijmegen, the Netherlands.


Purpose To compare a reduced-intensity conditioning regimen (RIC) with a myeloablative conditioning regimen (MAC) before allogeneic transplantation in patients with myelodysplastic syndrome (MDS) within a randomized trial. Patients and Methods Within the European Society of Blood and Marrow Transplantation, we conducted a prospective, multicenter, open-label, randomized phase III trial that compared a busulfan-based RIC with MAC in patients with MDS or secondary acute myeloid leukemia. A total of 129 patients were enrolled from 18 centers. Patients were randomly assigned in a 1:1 ratio and were stratified according to donor, age, and blast count. Results Engraftment was comparable between both groups. The CI of acute graft-versus-host disease II to IV was 32.3% after RIC and 37.5% after MAC ( P = .35). The CI of chronic graft-versus-host disease was 61.6% after RIC and 64.7% after MAC ( P = .76). The CI of nonrelapse mortality after 1 year was 17% (95% CI, 8% to 26%) after RIC and 25% (95% CI, 15% to 36%) after MAC ( P = .29). The CI of relapse at 2 years was 17% (95% CI, 8% to 26%) after RIC and 15% (95% CI, 6% to 24%) after MAC ( P = .6), which resulted in a 2-year relapse-free survival and overall survival of 62% (95% CI, 50% to 74%) and 76% (95% CI, 66% to 87%), respectively, after RIC, and 58% (95% CI, 46% to 71%) and 63% (95% CI, 51% to 75%), respectively, after MAC ( P = .58 and P = .08, respectively). Conclusion This prospective, randomized trial of the European Society of Blood and Marrow Transplantation provides evidence that RIC resulted in at least a 2-year relapse-free survival and overall survival similar to MAC in patients with MDS or secondary acute myeloid leukemia.

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