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
- Socié, Gérard Service d'Hématologie-Greffe de Moelle, Hôpital Saint Louis, Paris, France;
- Schmoor, Claudia Clinical Trials Center Universitätsklinikum Freiburg, Freiburg, Germany;
- Bethge, Wolfgang A. Department of Hematology and Oncology, Universitätsklinikum Tübingen, Tübingen, Germany;
- Ottinger, Hellmut D. Klinik und Poliklinik für KMT, Universitätsklinikum Essen, Essen, Germany;
- Stelljes, Matthias Department of Hematology and Oncology, Universitätsklinik Münster, Münster, Germany;
- Zander, Axel R. Department of Internal Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany;
- Volin, Liisa Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland;
- Ruutu, Tapani Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland;
- Heim, Dominik A. Department of Hematology, Universitätsspital Basel, Basel, Switzerland;
- Schwerdtfeger, Rainer Centre of Blood and Bone Marrow Transplantation, Stiftung Deutsche Klinik für Diagnostik, Wiesbaden, Germany;
- Kolbe, Karin Department of Internal Medicine, Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Mainz, Germany;
- Mayer, Jiri Department of Internal Medicine, Hemato-oncology, University Hospital Brno, Brno, Czech Republic;
- Maertens, Johan A. Department of Hematology, I.K. UZ Gasthuisberg, Leuven, Belgium;
- Linkesch, Werner Department of Hematology, Medizinisches Universitätsklinikum Graz, Graz, Austria;
- Holler, Ernst Department of Hematology and Oncology, Klinikum der Universität Regensburg, Regensburg, Germany;
- Koza, Vladimir Department of Hematology and Oncology, Charles University Hospital, Plzen, Czech Republic;
- Bornhäuser, Martin Center for Bone Marrow Transplantation, Universitätsklinikum Carl Gustav Carus, Dresden, Germany;
- Einsele, Hermann Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Germany;
- Kolb, Hans-Jochem Department of Hematology, Klinikum Großhadern, München, Germany; and
- Bertz, Hartmut Department of Hematology and Oncology, Universitätsklinikum Freiburg, Freiburg, Germany
- Egger, Matthias Department of Hematology and Oncology, Universitätsklinikum Freiburg, Freiburg, Germany
- Grishina, Olga Clinical Trials Center Universitätsklinikum Freiburg, Freiburg, Germany;
- Finke, Jürgen Department of Hematology and Oncology, Universitätsklinikum Freiburg, Freiburg, Germany
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.
- Language
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- English
- Open access status
- closed
- Identifiers
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- DOI 10.1182/blood-2011-01-329821
- ISSN 0006-4971
- Persistent URL
- https://sonar.ch/global/documents/93923
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