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Blood, 15 May 2007, Vol. 109, No. 10, pp. 4557-4563. Prepublished online as a Blood First Edition Paper on January 23, 2007; DOI 10.1182/blood-2006-05-021139. This Article Full Text (PDF) Supplemental Appendix All Versions of this Article: blood-2006-05-021139v1 109/10/4557    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager patientINFORMation Rights and Permissions Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Hockenbery, D. M. Articles by McDonald, G. B. Search for Related Content PubMed PubMed Citation Articles by Hockenbery, D. M. Articles by McDonald, G. B. Related Collections Related Article in Blood Online Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted May 9, 2006 Accepted January 12, 2007 A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease David M. Hockenbery, Scott Cruickshank, Timothy C, Rodell, Ted Gooley, Friedrich G Schuening, Scott D. Rowley, Donald David, Mark Brunvand, Brian Berryman, Sunil Abhyankar, Michelle E. Bouvier, and George B. McDonald* Fred Hutchinson Cancer Research Center & University of Washington School of Medicine, Seattle, WA, United States DOR BioPharma, Inc., Miami, FL, United States Vanderbilt University School of Medicine, Nashville, TN, United States Hackensack University Medical Center, Hackensack, NJ, United States City of Hope National Medical Center, Duarte, CA, United States Rocky Mountain Blood & Marrow Transplant Program, Denver, CO, United States Baylor University School of Medicine, Dallas, TX, United States Oncology & Hematology Associates, Kansas City, MO, United States * Corresponding author; email: gmcdonal{at}fhcrc.org. We tested the hypothesis that oral beclomethasone dipropionate (BDP) would control gastrointestinal graft-vs-host-disease (anorexia, vomiting, and diarrhea). Patients were randomized to prednisone for ten days and either oral BDP 8 mg/day (N=62) or placebo (N=67) tablets for fifty days. At Study Day-10, prednisone was rapidly tapered while continuing study drug. On an intent-to-treat basis, the risk of GVHD-treatment failure was reduced for the BDP group at Study Day-50 (hazard ratio 0.63, 95% CI 0.35-1.13) and at 30 days follow-up (HR 0.55, 95% CI 0.32, 0.93). Among patients eligible for prednisone taper at Study Day-10, the risk of GVHD-treatment failure was significantly reduced at both Study Days-50 and -80 (HR 0.39 and 0.38, respectively). By day-200 post-transplant, 5 patients randomized to BDP had died, compared to 16 deaths on placebo, a 67% reduction in the hazard of mortality (HR 0.33, p=0.03). In 47 recipients of unrelated and HLA-mismatched stem cells, mortality at transplant day-200 was reduced by 91% in the BDP group, compared to placebo (HR 0.09, p=0.02). The survival benefit was durable to one-year post-randomization. Oral BDP prevents relapses of gastrointestinal GVHD following tapering of prednisone; survival is statistically significantly better among patients receiving BDP. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? Find additional patient-related information at: New Pill Improves Side Effect of Stem Cell Transplants Related Article in Blood Online: At last, an "ointment" for gastrointestinal GVHD? Alois Gratwohl Blood 2007 109: 4117. [Full Text] [PDF]

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