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.
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.
authors.affiliation: Service d'Hématologie-Greffe de Moelle, Hôpital Saint Louis, Paris, France. gerard.socie@sls.aphp.fr
authors.forename: Gérard
authors.initials: G
authors.lastname: Socié
authors.forename: Claudia
authors.initials: C
authors.lastname: Schmoor
authors.forename: Wolfgang A
authors.initials: WA
authors.lastname: Bethge
authors.forename: Hellmut D
authors.initials: HD
authors.lastname: Ottinger
authors.forename: Matthias
authors.initials: M
authors.lastname: Stelljes
authors.forename: Axel R
authors.initials: AR
authors.lastname: Zander
authors.forename: Liisa
authors.initials: L
authors.lastname: Volin
authors.forename: Tapani
authors.initials: T
authors.lastname: Ruutu
authors.forename: Dominik A
authors.initials: DA
authors.lastname: Heim
authors.forename: Rainer
authors.initials: R
authors.lastname: Schwerdtfeger
authors.forename: Karin
authors.initials: K
authors.lastname: Kolbe
authors.forename: Jiri
authors.initials: J
authors.lastname: Mayer
authors.forename: Johan A
authors.initials: JA
authors.lastname: Maertens
authors.forename: Werner
authors.initials: W
authors.lastname: Linkesch
authors.forename: Ernst
authors.initials: E
authors.lastname: Holler
authors.forename: Vladimir
authors.initials: V
authors.lastname: Koza
authors.forename: Martin
authors.initials: M
authors.lastname: Bornhäuser
authors.forename: Hermann
authors.initials: H
authors.lastname: Einsele
authors.forename: Hans-Jochem
authors.initials: HJ
authors.lastname: Kolb
authors.forename: Hartmut
authors.initials: H
authors.lastname: Bertz
authors.forename: Matthias
authors.initials: M
authors.lastname: Egger
authors.forename: Olga
authors.initials: O
authors.lastname: Grishina
authors.forename: Jürgen
authors.initials: J
authors.lastname: Finke
mesh_terms: D000293:Adolescent; D000328:Adult; D000961:Antilymphocyte Serum / Q000008:administration & dosage*; D002908:Chronic Disease; D016572:Cyclosporine / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006086:Graft vs Host Disease / Q000401:mortality* / Q000517:prevention & control*; D019337:Hematologic Neoplasms / Q000401:mortality / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D012008:Recurrence; D015996:Survival Rate; D013997:Time Factors; D019172:Transplantation Conditioning; D014184:Transplantation, Homologous
chemical_list: D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D008727:Methotrexate