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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, Vol. 374, No. 1, 07.01.2016, p. 43-53.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Kröger, N, Solano, C, Wolschke, C, Bandini, G, Patriarca, F, Pini, M, Nagler, A, Selleri, C, Risitano, A, Messina, G, Bethge, W, Pérez de Oteiza, J, Duarte, R, Carella, AM, 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, Völp, A, Ayuketang, FA, Ruutu, T & Bonifazi, F 2016, 'Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease', NEW ENGL J MED, vol. 374, no. 1, pp. 43-53. https://doi.org/10.1056/NEJMoa1506002

APA

Kröger, N., Solano, C., Wolschke, C., Bandini, G., Patriarca, F., Pini, M., Nagler, A., Selleri, C., Risitano, A., Messina, G., Bethge, W., Pérez de Oteiza, J., Duarte, R., Carella, A. M., Cimminiello, M., Guidi, S., Finke, J., Mordini, N., Ferra, C., ... Bonifazi, F. (2016). Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease. NEW ENGL J MED, 374(1), 43-53. https://doi.org/10.1056/NEJMoa1506002

Vancouver

Kröger N, Solano C, Wolschke C, Bandini G, Patriarca F, Pini M et al. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease. NEW ENGL J MED. 2016 Jan 7;374(1):43-53. https://doi.org/10.1056/NEJMoa1506002

Bibtex

@article{ca15c824d7b740bbb5c71dd9991e7b2c,
title = "Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease",
abstract = "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.).",
keywords = "Adolescent, Adult, Antilymphocyte Serum, Child, Child, Preschool, Chronic Disease, Disease-Free Survival, Female, Graft vs Host Disease, Humans, Immunosuppressive Agents, Incidence, Male, Middle Aged, Proportional Hazards Models, Prospective Studies, Survival Rate, T-Lymphocytes, Transplantation, Homologous, Young Adult, POM-Newsletter",
author = "Nicolaus Kr{\"o}ger and Carlos Solano and Christine Wolschke and Giuseppe Bandini and Francesca Patriarca and Massimo Pini and Arnon Nagler and Carmine Selleri and Antonio Risitano and Giuseppe Messina and Wolfgang Bethge and {P{\'e}rez de Oteiza}, Jaime and Rafael Duarte and Carella, {Angelo Michele} and Michele Cimminiello and Stefano Guidi and J{\"u}rgen Finke and Nicola Mordini and Christelle Ferra and Jorge Sierra and Domenico Russo and Mario Petrini and Giuseppe Milone and Fabio Benedetti and Marion Heinzelmann and Domenico Pastore and Manuel Jurado and Elisabetta Terruzzi and Franco Narni and Andreas V{\"o}lp and Ayuketang, {Francis Ayuk} and Tapani Ruutu and Francesca Bonifazi",
year = "2016",
month = jan,
day = "7",
doi = "10.1056/NEJMoa1506002",
language = "English",
volume = "374",
pages = "43--53",
journal = "NEW ENGL J MED",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "1",

}

RIS

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 -