TY - JOUR
T1 - Chronic graft-versus-host disease
T2 - Long-term results from a randomized trial on graft-versus-host disease prophylaxis with or without anti-T-cell globulin ATG-Fresenius
AU - Socié, Gérard
AU - Schmoor, Claudia
AU - Bethge, Wolfgang A.
AU - Ottinger, Hellmut D.
AU - Stelljes, Matthias
AU - Zander, Axel R.
AU - Volin, Liisa
AU - Ruutu, Tapani
AU - Heim, Dominik A.
AU - Schwerdtfeger, Rainer
AU - Kolbe, Karin
AU - Mayer, Jiri
AU - Maertens, Johan A.
AU - Linkesch, Werner
AU - Holler, Ernst
AU - Koza, Vladimir
AU - Bornhäuser, Martin
AU - Einsele, Hermann
AU - Kolb, Hans Jochem
AU - Bertz, Hartmut
AU - Egger, Matthias
AU - Grishina, Olga
AU - Finke, Jürgen
PY - 2011/6/9
Y1 - 2011/6/9
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=79959456118&partnerID=8YFLogxK
U2 - 10.1182/blood-2011-01-329821
DO - 10.1182/blood-2011-01-329821
M3 - Article
C2 - 21467544
AN - SCOPUS:79959456118
SN - 0006-4971
VL - 117
SP - 6375
EP - 6382
JO - Blood
JF - Blood
IS - 23
ER -