Shen transplanted from an immunologically different person, graft cells can attack the host’s body. This is called Graft Versus Host Diseas*GVHD)e and remains a serious problem in transplantation. One trial by Koreth and others found that Velcade was beneficial in GVHD; but his was a phase II trial other phase II trials are ongoing. Koreth treated 45 patients; 89% of patients who were treated had a one-locus and 11% of patients were treated with a two-loci mismatch. With a median follow-up of 3 years, the 180-day cumulative incidence of grade 2 to 4 acute GVHD was 22%, and the 1-year cumulative incidence of chronic GVHD was 29%. The non-relapse mortality rate was only 11%, and the relapse rate was 38%. Results were comparable with patients who received HLA-matched transplants with the unexpected observation that bortezomib therapy enhanced immune reconstitution of CD8+ T cells and natural killer cells.
The editorial by Giralt that accompanied Koreth report, pointed out that there are four potential approaches to developing treatments for GVHD problem and that it may be necessary to perform a randomized phase II trial with a short primary end point to be able to rapidly pick a winner from among these competing approaches that could be compared with the current standard in a definitive trial.
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