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

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

書誌事項

公開日
2011-06-09
DOI
  • 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

  • Blood

    Blood 117 (23), 6375-6382, 2011-06-09

    American Society of Hematology

被引用文献 (12)*注記

もっと見る

詳細情報 詳細情報について

問題の指摘

ページトップへ