title: A randomized, placebo-controlled trial of oral beclomethasone dipropionate as a prednisone-sparing therapy for gastrointestinal graft-versus-host disease.
abstract: 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.
authors.affiliation: Fred Hutchinson Cancer Research Center, University of Washington, School of Medicine, Seattle, WA 98109-1024, USA. dhockenb@fhcrc.org
authors.forename: David M
authors.initials: DM
authors.lastname: Hockenbery
authors.forename: Scott
authors.initials: S
authors.lastname: Cruickshank
authors.forename: Timothy C
authors.initials: TC
authors.lastname: Rodell
authors.forename: Ted
authors.initials: T
authors.lastname: Gooley
authors.forename: Friedrich
authors.initials: F
authors.lastname: Schuening
authors.forename: Scott
authors.initials: S
authors.lastname: Rowley
authors.forename: Donald
authors.initials: D
authors.lastname: David
authors.forename: Mark
authors.initials: M
authors.lastname: Brunvand
authors.forename: Brian
authors.initials: B
authors.lastname: Berryman
authors.forename: Sunil
authors.initials: S
authors.lastname: Abhyankar
authors.forename: Michelle
authors.initials: M
authors.lastname: Bouvier
authors.forename: George B
authors.initials: GB
authors.lastname: McDonald
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage; D001507:Beclomethasone / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D006086:Graft vs Host Disease / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011241:Prednisone / Q000494:pharmacology; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D010919:Placebos; D001507:Beclomethasone; D011241:Prednisone