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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.

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TRANSPLANTATION

A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease

David M. Hockenbery1, Scott Cruickshank2, Timothy C. Rodell2, Ted Gooley1, Friedrich Schuening3, Scott Rowley4, Donald David5, Mark Brunvand6, Brian Berryman7, Sunil Abhyankar8, Michelle Bouvier1, George B. McDonald, for the orBec GVHD Study Group1

1 Fred Hutchinson Cancer Research Center and University of Washington School of Medicine, Seattle; 2 DOR BioPharma Inc, Miami, FL; 3 Vanderbilt University School of Medicine, Nashville, TN; 4 Hackensack University Medical Center, NJ; 5 City of Hope National Medical Center, Duarte, CA; 6 Rocky Mountain Blood & Marrow Transplant Program, Denver, CO; 7 Baylor University School of Medicine, Dallas, TX; 8 Oncology & Hematology Associates, Kansas City, MO

We tested the hypothesis that oral beclomethasone dipropionate (BDP) would control gastrointestinal graft-versus-host disease (GVHD) in patients with anorexia, vomiting, and diarrhea. Patients were randomized to prednisone for 10 days and either oral BDP 8 mg/d (n = 62) or placebo (n = 67) tablets for 50 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 [HR] 0.63, 95% confidence interval [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 after transplantation, 5 patients randomized to BDP had died compared with 16 deaths on placebo, a 67% reduction in the hazard of mortality (HR 0.33, P = .03). In 47 recipients of unrelated and HLA-mismatched stem cells, mortality at transplantation day 200 was reduced by 91% in the BDP group compared with placebo (HR 0.09, P = .02). The survival benefit was durable to 1 year after randomization. Oral BDP prevents relapses of gastrointestinal GVHD following tapering of prednisone; survival is statistically significantly better among patients receiving BDP.


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New Pill Improves Side Effect of Stem Cell Transplants

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