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.

Socie, G; Schmoor, C; Bethge, WA; Ottinger, HD; Stelljes, M; Zander, AR; Volin, L; Ruutu, T; Heim, DA; Schwerdtfeger, R; Kolbe, K; Mayer, J; Maertens, JA; Linkesch, W; Holler, E; Koza, V; Bornhäuser, M; Einsele, H; Kolb, HJ; Bertz, H; Egger, M; Grishina, O; Finke, J

doi:10.1182/blood-2011-01-329821

2011

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Title:: 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.
Document type:: Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Author(s):: Socie, G; Schmoor, C; Bethge, WA; Ottinger, HD; Stelljes, M; Zander, AR; Volin, L; Ruutu, T; Heim, DA; Schwerdtfeger, R; Kolbe, K; Mayer, J; Maertens, JA; Linkesch, W; Holler, E; Koza, V; Bornhäuser, M; Einsele, H; Kolb, HJ; Bertz, H; Egger, M; Grishina, O; Finke, J
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.
Journal title abbreviation:: Blood
Year:: 2011
Journal volume:: 117
Journal issue:: 23
Pages contribution:: 6375-82
Language:: eng
Fulltext / DOI:: doi:10.1182/blood-2011-01-329821
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/21467544
Print-ISSN:: 0006-4971
TUM Institution:: III. Medizinische Klinik und Poliklinik (Hämatologie / Onkologie)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie (Prof. Bassermann)2011