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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- Gérard Socié
- Service d'Hématologie-Greffe de Moelle, Hôpital Saint Louis, Paris, France;
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- Claudia Schmoor
- Clinical Trials Center Universitätsklinikum Freiburg, Freiburg, Germany;
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- Wolfgang A. Bethge
- Department of Hematology and Oncology, Universitätsklinikum Tübingen, Tübingen, Germany;
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- Hellmut D. Ottinger
- Klinik und Poliklinik für KMT, Universitätsklinikum Essen, Essen, Germany;
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- Matthias Stelljes
- Department of Hematology and Oncology, Universitätsklinik Münster, Münster, Germany;
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- Axel R. Zander
- Department of Internal Medicine, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany;
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- Liisa Volin
- Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland;
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- Tapani Ruutu
- Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland;
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- Dominik A. Heim
- Department of Hematology, Universitätsspital Basel, Basel, Switzerland;
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- Rainer Schwerdtfeger
- Centre of Blood and Bone Marrow Transplantation, Stiftung Deutsche Klinik für Diagnostik, Wiesbaden, Germany;
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- Karin Kolbe
- Department of Internal Medicine, Universitätsmedizin der Johannes-Gutenberg-Universität Mainz, Mainz, Germany;
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- Jiri Mayer
- Department of Internal Medicine, Hemato-oncology, University Hospital Brno, Brno, Czech Republic;
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- Johan A. Maertens
- Department of Hematology, I.K. UZ Gasthuisberg, Leuven, Belgium;
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- Werner Linkesch
- Department of Hematology, Medizinisches Universitätsklinikum Graz, Graz, Austria;
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- Ernst Holler
- Department of Hematology and Oncology, Klinikum der Universität Regensburg, Regensburg, Germany;
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- Vladimir Koza
- Department of Hematology and Oncology, Charles University Hospital, Plzen, Czech Republic;
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- Martin Bornhäuser
- Center for Bone Marrow Transplantation, Universitätsklinikum Carl Gustav Carus, Dresden, Germany;
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- Hermann Einsele
- Medizinische Klinik und Poliklinik II, Universitätsklinik Würzburg, Würzburg, Germany;
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- Hans-Jochem Kolb
- Department of Hematology, Klinikum Großhadern, München, Germany; and
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- Hartmut Bertz
- Department of Hematology and Oncology, Universitätsklinikum Freiburg, Freiburg, Germany
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- Matthias Egger
- Department of Hematology and Oncology, Universitätsklinikum Freiburg, Freiburg, Germany
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- Olga Grishina
- Clinical Trials Center Universitätsklinikum Freiburg, Freiburg, Germany;
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- Jürgen Finke
- Department of Hematology and Oncology, Universitätsklinikum Freiburg, Freiburg, Germany
書誌事項
- 公開日
- 2011-06-09
- DOI
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- 10.1182/blood-2011-01-329821
- 公開者
- American Society of Hematology
この論文をさがす
説明
<jats:title>Abstract</jats:title> <jats:p>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.</jats:p>
収録刊行物
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- Blood
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Blood 117 (23), 6375-6382, 2011-06-09
American Society of Hematology
