Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease
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Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease. / Kröger, Nicolaus; Solano, Carlos; Wolschke, Christine; Bandini, Giuseppe; Patriarca, Francesca; Pini, Massimo; Nagler, Arnon; Selleri, Carmine; Risitano, Antonio; Messina, Giuseppe; Bethge, Wolfgang; Pérez de Oteiza, Jaime; Duarte, Rafael; Carella, Angelo Michele; Cimminiello, Michele; Guidi, Stefano; Finke, Jürgen; Mordini, Nicola; Ferra, Christelle; Sierra, Jorge; Russo, Domenico; Petrini, Mario; Milone, Giuseppe; Benedetti, Fabio; Heinzelmann, Marion; Pastore, Domenico; Jurado, Manuel; Terruzzi, Elisabetta; Narni, Franco; Völp, Andreas; Ayuketang, Francis Ayuk; Ruutu, Tapani; Bonifazi, Francesca.
in: NEW ENGL J MED, Jahrgang 374, Nr. 1, 07.01.2016, S. 43-53.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease
AU - Kröger, Nicolaus
AU - Solano, Carlos
AU - Wolschke, Christine
AU - Bandini, Giuseppe
AU - Patriarca, Francesca
AU - Pini, Massimo
AU - Nagler, Arnon
AU - Selleri, Carmine
AU - Risitano, Antonio
AU - Messina, Giuseppe
AU - Bethge, Wolfgang
AU - Pérez de Oteiza, Jaime
AU - Duarte, Rafael
AU - Carella, Angelo Michele
AU - Cimminiello, Michele
AU - Guidi, Stefano
AU - Finke, Jürgen
AU - Mordini, Nicola
AU - Ferra, Christelle
AU - Sierra, Jorge
AU - Russo, Domenico
AU - Petrini, Mario
AU - Milone, Giuseppe
AU - Benedetti, Fabio
AU - Heinzelmann, Marion
AU - Pastore, Domenico
AU - Jurado, Manuel
AU - Terruzzi, Elisabetta
AU - Narni, Franco
AU - Völp, Andreas
AU - Ayuketang, Francis Ayuk
AU - Ruutu, Tapani
AU - Bonifazi, Francesca
PY - 2016/1/7
Y1 - 2016/1/7
N2 - 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.).
AB - 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.).
KW - Adolescent
KW - Adult
KW - Antilymphocyte Serum
KW - Child
KW - Child, Preschool
KW - Chronic Disease
KW - Disease-Free Survival
KW - Female
KW - Graft vs Host Disease
KW - Humans
KW - Immunosuppressive Agents
KW - Incidence
KW - Male
KW - Middle Aged
KW - Proportional Hazards Models
KW - Prospective Studies
KW - Survival Rate
KW - T-Lymphocytes
KW - Transplantation, Homologous
KW - Young Adult
KW - POM-Newsletter
U2 - 10.1056/NEJMoa1506002
DO - 10.1056/NEJMoa1506002
M3 - SCORING: Journal article
C2 - 26735993
VL - 374
SP - 43
EP - 53
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 1
ER -