Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease
Por:
Kroger N, Solano C, Wolschke C, Bandini G, Patriarca F, Pini M, Nagler A, Selleri C, Risitano A, Messina G, Bethge W, de Oteiza J, Duarte R, Carella A, Cimminiello M, Guidi S, Finke J, Mordini N, Ferra C, Sierra J, Russo D, Petrini M, Milone G, Benedetti F, Heinzelmann M, Pastore D, Jurado M, Terruzzi E, Narni F, Volp A, Ayuk F, Ruutu T, Bonifazi F
Publicada:
7 ene 2016
Categoría:
Medicine (miscellaneous)
Resumen:
BACKGROUND
Chronic graft-versus-host disease (GVHD) is the leading cause of later illness and death after allogeneic hematopoietic stem-cell transplantation. We hypothesized that the inclusion of antihuman T-lymphocyte immune globulin (ATG) in a myeloablative conditioning regimen for patients with acute leukemia would result in a significant reduction in chronic GVHD 2 years after allogeneic peripheral-blood stem-cell transplantation from an HLA-identical sibling.
METHODS
We conducted a prospective, multicenter, open-label, randomized phase 3 study of ATG as part of a conditioning regimen. A total of 168 patients were enrolled at 27 centers. Patients were randomly assigned in a 1:1 ratio to receive ATG or not receive ATG, with stratification according to center and risk of disease.
RESULTS
After a median follow-up of 24 months, the cumulative incidence of chronic GVHD was 32.2% (95% confidence interval [CI], 22.1 to 46.7) in the ATG group and 68.7% (95% CI, 58.4 to 80.7) in the non-ATG group (P<0.001). The rate of 2-year relapse-free survival was similar in the ATG group and the non-ATG group (59.4% [95% CI, 47.8 to 69.2] and 64.6% [95% CI, 50.9 to 75.3], respectively; P=0.21), as was the rate of overall survival (74.1% [95% CI, 62.7 to 82.5] and 77.9% [95% CI, 66.1 to 86.1], respectively; P=0.46). There were no significant between-group differences in the rates of relapse, infectious complications, acute GVHD, or adverse events. The rate of a composite end point of chronic GVHD-free and relapse-free survival at 2 years was significantly higher in the ATG group than in the non-ATG group (36.6% vs. 16.8%, P=0.005).
CONCLUSIONS
The inclusion of ATG resulted in a significantly lower rate of chronic GVHD after allogeneic transplantation than the rate without ATG. The survival rate was similar in the two groups, but the rate of a composite end point of chronic GVHD-free survival and relapse-free survival was higher with ATG. (Funded by the Neovii Biotech and the European Society for Blood and Marrow Transplantation; ClinicalTrials.gov number, NCT00678275.)
Filiaciones:
Kroger N:
Univ Med Ctr Hamburg Eppendorf, Hamburg, Germany
Solano C:
Hosp Clin Univ, Valencia, Spain
Wolschke C:
Univ Med Ctr Hamburg Eppendorf, Hamburg, Germany
Bandini G:
Univ Bologna, S Orsola Malpighi Univ Hosp, Bologna, Italy
Patriarca F:
Univ Udine, DISM, Hematol, Udine, Italy
Pini M:
Azienda Ospedaliera SS Antonio & Biagio & C Arrig, Alessandria, Italy
Nagler A:
Chaim Sheba Med Ctr, Ramat Gan, Israel
Selleri C:
Univ Naples Federico II, Naples, Italy
Univ Salerno, I-84100 Salerno, Italy
Risitano A:
Univ Naples Federico II, Naples, Italy
Messina G:
AO Bianchi Melacrino Morelli, Reggio Di Calabria, Italy
Bethge W:
Univ Hosp Tubingen, Tubingen, Germany
de Oteiza J:
Hosp Ramon & Cajal, E-28034 Madrid, Spain
Duarte R:
Hosp Univ Puerta Hierro Majadahonda, Madrid, Spain
Carella A:
Osped Casa Sollievo Sofferenza IRCCCS, San Giovanni Rotondo, Italy
Cimminiello M:
Azienda Osped San Carlo, Potenza, Italy
Guidi S:
Azienda Osped Careggi, Florence, Italy
Finke J:
Univ Hosp Freiburg, Freiburg, Germany
Mordini N:
Osped Santa Croce & Carle, Cuneo, Italy
Ferra C:
Hosp Badalona Germans Trias & Pujol, Inst Catal Oncol, Serv Hematol, Badalona, Spain
Sierra J:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Russo D:
Univ Brescia, Dept Clin & Expt Sci, Brescia, Italy
Petrini M:
Univ Pisa, Dept Clin & Expt Med, Pisa, Italy
Milone G:
Azienda Policlin Vittorio Emanuele, Programma Trapianto Emopoiet Metropolitano, Catania, Italy
Benedetti F:
Policlin GB Rossi, Verona, Italy
Heinzelmann M:
Univ Med Ctr Hamburg Eppendorf, Hamburg, Germany
Pastore D:
Univ Osped, Azienda Osped, Bari, Italy
Jurado M:
Hosp Virgen Nieves, Granada, Spain
Terruzzi E:
Osped San Gerardo, Monza, Italy
Narni F:
Policlin Modena, Modena, Italy
Volp A:
Psy Consult, Frankfurt, Germany
Ayuk F:
Univ Med Ctr Hamburg Eppendorf, Hamburg, Germany
Ruutu T:
Helsinki Univ Hosp, Helsinki, Finland
Bonifazi F:
Univ Bologna, S Orsola Malpighi Univ Hosp, Bologna, Italy
Open Access
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