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Addition of Antithymocyte Globulin to Graft-vs-Host Disease Prophylaxis in Matched Sibling Donor Stem Cell Transplant


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In a Chinese trial reported in the Journal of Clinical Oncology, Chang et al found that the addition of antithymocyte globulin to standard graft-vs-host disease prophylaxis reduced the risk of acute graft-vs-host disease in patients undergoing human leukocyte antigen (HLA)-matched sibling donor hematopoietic stem cell transplantation for hematologic malignancies.

Study Details

The open-label multicenter trial included 263 patients with standard-risk hematologic malignancies undergoing matched sibling donor transplant. Patients were randomly assigned between November 2013 and April 2018 to receive antithymocyte globulin (ATG; 4.5 mg/kg thymoglobulin) plus cyclosporine (CsA), methotrexate (MTX), and mycophenolate mofetil (MMF; n = 132) or CsA/MTX/MMF alone (n =131). The primary endpoint was grade 2 to 4 acute graft-vs-host disease on day 100.

Key Findings

The cumulative incidence of grade 2 to 4 acute graft-vs-host disease at 30 days was 13.7% in the ATG group vs 27.0% in the control group (P = .007). A reduction in grade 3 or 4 acute graft-vs-host disease did not reach statistical significance (8.4% vs 14.2%, P = .151).

The incidence of 2-year overall chronic graft-vs-host disease was 27.9% vs 52.5% (P < .001), with extensive chronic graft-vs-host disease observed in 8.5% vs 23.2% (P = .029). Graft-vs-host disease relapse–free survival at 3 years was 38.7% vs 24.5% (P = .003).

At 3 years, nonrelapse mortality was 9.9% vs 14.3% (P = .552); cumulative incidence of relapse was 20.8% vs 15.4% (P = .362); and overall survival was 69.0% vs 70.4% (P = .937). There were no differences between the ATG and control groups with regard to cytomegalovirus or Epstein-Barr virus reactivation.

The investigators concluded, “Our study is the first prospective randomized controlled trial in our knowledge to demonstrate that ATG can effectively decrease the incidence of acute [graft-vs-host disease] after [HLA-matched sibling donor transplantation] in the CsA era without affecting the cumulative incidence of relapse or nonrelapse mortality.”

Xiao-Jun Huang, MD, of Peking University People’s Hospital, Peking University Institute of Hematology, Beijing, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by the Foundation for Innovative Research Groups of the National Natural Science Foundation of China and others. For full disclosures of the study authors, visit ascopubs.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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