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, Gerard and Schmoor, Claudia and Bethge, Wolfgang A. and Ottinger, Hellmut D. and Stelljes, Matthias and Zander, Axel R. and Volin, Liisa and Ruutu, Tapani and Heim, Dominik A. and Schwerdtfeger, Rainer and Kolbe, Karin and Mayer, Jiri and Maertens, Johan A. and Linkesch, Werner and Holler, Ernst and Koza, Vladimir and Bornhaeuser, Martin and Einsele, Hermann and Kolb, Hans-Jochem and Bertz, Hartmut and Egger, Matthias and Grishina, Olga and Finke, Juergen (2011) 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. BLOOD, 117 (23). pp. 6375-6382. ISSN 0006-4971,

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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. (Blood. 2011; 117(23): 6375-6382)

Item Type: Article
Uncontrolled Keywords: BONE-MARROW-TRANSPLANTATION; CONSENSUS DEVELOPMENT PROJECT; MATCHED UNRELATED DONORS; WORKING GROUP-REPORT; FOLLOW-UP; ANTITHYMOCYTE GLOBULIN; CLINICAL-TRIALS; COMPETING RISKS; DEPLETION; SURVIVAL;
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie)
Depositing User: Dr. Gernot Deinzer
Date Deposited: 09 Jun 2020 06:45
Last Modified: 09 Jun 2020 06:45
URI: https://pred.uni-regensburg.de/id/eprint/20667

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