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, Claudia Schmoor, Wolfgang A. Bethge, Hellmut D. Ottinger, Matthias Stelljes, Axel R. Zander, Liisa Volin, Tapani Ruutu, Dominik A. Heim, Rainer Schwerdtfeger, Karin Kolbe, Jiri Mayer, Johan A. Maertens, Werner Linkesch, Ernst Holler, Vladimir Koza, Martin Bornhäuser, Hermann Einsele, Hans Jochem Kolb, Hartmut BertzMatthias Egger, Olga Grishina, Jürgen Finke

Research output: Contribution to journalArticlepeer-review

255 Scopus citations

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.

Original languageEnglish
Pages (from-to)6375-6382
Number of pages8
JournalBlood
Volume117
Issue number23
DOIs
StatePublished - 9 Jun 2011
Externally publishedYes

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