Journal article
Chronic graft-versus-host disease: long-term results from a randomized trial on graft-versus-host disease prophylaxis with or without anti–T-cell globulin ATG-Fresenius
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Socié, Gérard
Service d'Hématologie-Greffe de Moelle, Hôpital Saint Louis, Paris, France;
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Schmoor, Claudia
Clinical Trials Center Universitätsklinikum Freiburg, Freiburg, Germany;
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Bethge, Wolfgang A.
Department of Hematology and Oncology, Universitätsklinikum Tübingen, Tübingen, Germany;
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Ottinger, Hellmut D.
Klinik und Poliklinik für KMT, Universitätsklinikum Essen, Essen, Germany;
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Stelljes, Matthias
Department of Hematology and Oncology, Universitätsklinik Münster, Münster, Germany;
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Zander, Axel R.
Department of Internal Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany;
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Volin, Liisa
Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland;
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Ruutu, Tapani
Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland;
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Heim, Dominik A.
Department of Hematology, Universitätsspital Basel, Basel, Switzerland;
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Schwerdtfeger, Rainer
Centre of Blood and Bone Marrow Transplantation, Stiftung Deutsche Klinik für Diagnostik, Wiesbaden, Germany;
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Kolbe, Karin
Department of Internal Medicine, Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Mainz, Germany;
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Mayer, Jiri
Department of Internal Medicine, Hemato-oncology, University Hospital Brno, Brno, Czech Republic;
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Maertens, Johan A.
Department of Hematology, I.K. UZ Gasthuisberg, Leuven, Belgium;
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Linkesch, Werner
Department of Hematology, Medizinisches Universitätsklinikum Graz, Graz, Austria;
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Holler, Ernst
Department of Hematology and Oncology, Klinikum der Universität Regensburg, Regensburg, Germany;
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Koza, Vladimir
Department of Hematology and Oncology, Charles University Hospital, Plzen, Czech Republic;
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Bornhäuser, Martin
Center for Bone Marrow Transplantation, Universitätsklinikum Carl Gustav Carus, Dresden, Germany;
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Einsele, Hermann
Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Germany;
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Kolb, Hans-Jochem
Department of Hematology, Klinikum Großhadern, München, Germany; and
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Bertz, Hartmut
Department of Hematology and Oncology, Universitätsklinikum Freiburg, Freiburg, Germany
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Egger, Matthias
Department of Hematology and Oncology, Universitätsklinikum Freiburg, Freiburg, Germany
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Grishina, Olga
Clinical Trials Center Universitätsklinikum Freiburg, Freiburg, Germany;
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Finke, Jürgen
Department of Hematology and Oncology, Universitätsklinikum Freiburg, Freiburg, Germany
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Published in:
- Blood. - American Society of Hematology. - 2011, vol. 117, no. 23, p. 6375-6382
English
Abstract
Previous randomized graft-versus-host disease (GVHD)-prophylaxis trials have failed to demonstrate reduced incidence and severity of chronic GVHD (cGVHD). Here we reanalyzed and updated a randomized phase 3 trial comparing standard GVHD prophylaxis with or without pretransplantation ATG-Fresenius (ATG-F) in 201 adult patients receiving myeloablative conditioning before transplantation from unrelated donors. The cumulative incidence of extensive cGVHD after 3 years was 12.2% in the ATG-F group versus 45.0% in the control group (P < .0001). The 3-year cumulative incidence of relapse and of nonrelapse mortality was 32.6% and 19.4% in the ATG-F group and 28.2% and 33.5% in the control group (hazard ratio [HR] = 1.21, P = .47, and HR = 0.68, P = .18), respectively. This nonsignificant reduction in nonrelapse mortality without increased relapse risk led to an overall survival rate after 3 years of 55.2% in the ATG-F group and 43.3% in the control group (HR = 0.84, P = .39, nonsignificant). The HR for receiving immunosuppressive therapy (IST) was 0.31 after ATG-F (P < .0001), and the 3-year probability of survival free of IST was 52.9% and 16.9% in the ATG-F versus control, respectively. The addition of ATG-F to standard cyclosporine, methotrexate GVHD prophylaxis lowers the incidence and severity of cGVHD, and the risk of receiving IST without raising the relapse rate. ATG-F prophylaxis reduces cGVHD morbidity.
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Language
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Open access status
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closed
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Persistent URL
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https://sonar.ch/global/documents/93923
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