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Anti-T-Cell Globulin Reduces Incidence of Acute, Chronic Graft-Versus-Host Disease in Transplant Patients

NEW YORK -- August 18, 2009 -- Giving patients undergoing blood stem cell transplantation from an unrelated donor, standard graft-versus-host-disease (GVHD) prophylaxis in combination with anti-T-cell globulin (ATG), prevents both acute and chronic GVHD compared with standard treatment alone, without compromising survival or increasing relapse, according to a study published online first and in the September edition of The Lancet Oncology.

GVHD is a common complication after haematopoietic cell transplantation (HCT) from unrelated donors. Previous studies have suggested that ATGs might prevent GVHD.

To investigate further, Jürgen Finke, Universitätsklinikum Freiburg, Freiburg, Germany, and colleagues conducted a phase 3 trial in patients undergoing HCT from an unrelated donor to compare standard GVHD prophylaxis with anti-Jurkat ATG-Fresenius (ATG-F).

In total, 201 adult patients with haematological cancers undergoing HCT from an unrelated donor were recruited from 31 treatment centres in Europe and Israel between May 2003 and February 2007.

Patients were randomly assigned to prophylaxis with cyclosporine and methotrexate with or without additional ATG-F. The researchers assessed them for early treatment failure, defined as acute GVHD (aGVHD) grade 3 to 4 or death within 100 days of transplantation, and incidence of chronic GVHD (cGVHD).

Within 100 days of transplantation, 22 patients (21.4%) in the ATG-F group had aGVHD grade 3 to 4 or had died, compared with 33 patients (33.7%) in the standard treatment group. No significant benefit with ATG-F was shown within 100 days.

However, overall, findings showed that the incidence of aGVHD grade 3 to 4 was reduced in the ATG-F treatment group; 11.7% vs 24.5% in the standard treatment group. Nine patients died of aGVHD in the standard treatment group compared with only 1 patient in the ATG-F group.

Importantly, ATG-F had a significant effect in reducing cGVHD. The 2-year cumulative incidence of cGVHD and extensive cGVHD in the ATG-F group was 30.8% and 12.2%, respectively, compared with 58.8% and 42.6%, respectively, in the standard treatment group.

The authors pointed out that despite the advanced disease status of many patients, there were no increases in relapse, non-relapse mortality, overall survival, or deaths from infection in patients treated with ATG-F compared with controls.

"This is the first randomised clinical trial to show that ATG-F can reduce severe acute and clinically-relevant chronic GVHD without compromising disease-free survival or overall survival…The use of ATG-F is safe for patients who are going to receive transplantation from matched unrelated donors," the authors commented.

In an accompanying commentary, Francesco Frassoni, Ospedale San Martino, Genova, Italy said: "ATG looks like remaining an essential ingredient of HCT. For tomorrow's patient knowing that they can receive a transplant with a lower probability of developing both acute and chronic GVHD, without increasing the risk of recurrence of their disease, is reassuring."

SOURCE: The Lancet Oncology

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