WEDNESDAY, Aug. 19 (HealthDay News) -- The addition of anti-T-cell globulin (ATG) to standard graft-versus-host disease (GVHD) prophylaxis in patients undergoing hematopoietic cell transplantation from matched unrelated donors is safe and reduces the incidence of severe GVHD without affecting overall survival, according to a study published online Aug. 19 in The Lancet Oncology.
As part of an open-label, phase III trial, Jurgen Finke, M.D., from Universitatsklinikum Freiburg in Germany, and colleagues randomly assigned 202 patients with hematological malignancies who were undergoing allogeneic hematopoietic cell transplantation from unrelated donors to cyclosporin and methotrexate with or without additional anti-Jurkat ATG-Fresenius (ATG-F).
The researchers found that fewer patients in the ATG-F group developed severe acute GVHD or died within 100 days of transplantation (21.4 versus 33.7 percent; adjusted odds ratio, 0.59), though this did not reach statistical significance. Significantly fewer patients in the ATG-F group developed severe acute GVHD (11.7 versus 24.5 percent; adjusted hazard ratio, 0.50), and these patients had a significantly lower two-year incidence of extensive chronic GVHD (12.2 versus 42.6 percent; adjusted hazard ratio, 0.22). Both groups had similar rates of relapse, non-relapse mortality, overall survival, and mortality from infectious causes.
"The addition of ATG-F to GVHD prophylaxis with cyclosporin and methotrexate resulted in decreased incidence of acute and chronic GVHD without an increase in relapse or non-relapse mortality, and without compromising overall survival," Finke and colleagues conclude. "The use of ATG-F is safe for patients who are going to receive a hematopoietic cell transplantation from matched unrelated donors."
The study was supported by Fresenius Biotech GmbH, and several co-authors reported financial ties to the company.