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- Dokumenttyp:
- Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
- Autor(en):
- 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
- Titel:
- 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.
- 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.
- Zeitschriftentitel:
- Blood
- Jahr:
- 2011
- Band / Volume:
- 117
- Heft / Issue:
- 23
- Seitenangaben Beitrag:
- 6375-82
- Sprache:
- eng
- Volltext / DOI:
- doi:10.1182/blood-2011-01-329821
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/21467544
- Print-ISSN:
- 0006-4971
- TUM Einrichtung:
- III. Medizinische Klinik und Poliklinik (Hämatologie / Onkologie)
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