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Bortezomib shows promise in reducing GVHD and reconstituting immune system in some patients
Date:12/6/2009

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The new, Phase 1 clinical trial involved 23 patients who received bortezomib-based therapy (bortezomib, tacrolimus, and methotrexate) after reduced-intensity stem cell transplants from mismatched-unrelated donors. Three dosage levels of bortezomib were tested. In updated results on 35 bortezomib-based mismatched-unrelated patients reported at ASH, GVHD rates and extent of immune system reconstitution were compared with patients who had received sirolimus-based therapy (sirolimus, tacrolimus, and methotrexate) after transplants from matched-related donors, matched-unrelated donors, and mismatched-unrelated donors.

The results show that the bortezomib-based therapy was safe and had little toxicity. Transplanted stem cells took root, or "engrafted" reliably, and the rate of GVHD in the bortezomib-based mismatched-unrelated transplants was comparable to that in sirolimus-based matched-related transplants. Interestingly, immune cell reconstitution was significantly improved in the bortezomib-based patients in the early post-transplant period (3-6 months), compared with the sirolimus-based patients.

"Our results suggest that borezomib is a promising novel immunomodulatory agent in donor stem-cell transplantation," Koreth says. "A Phase 2 trial is now accruing patients to help determine its ultimate effectiveness."


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Contact: Teresa Herbert
teresa_herbert@dfci.harvard.edu
617-632-5653
Dana-Farber Cancer Institute
Source:Eurekalert

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