title: The use of oral beclomethasone dipropionate in the treatment of gastrointestinal graft-versus-host disease: the experience of the Fukuoka blood and marrow transplantation (BMT) group.
abstract: OBJECTIVE
  We examined the therapeutic strategies for treating mild gastrointestinal (GI) graft-versus-host disease (GVHD) using oral beclomethasone dipropionate (BDP) in 15 Japanese patients based on the donor source. The primary objective was to determine the efficacy and toxicity of oral BDP combined with/without low-dose prednisone (PSL).
  
  
  METHODS
  Oral BDP was administered with 1 mg/kg/d of PSL in patients undergoing bone marrow transplantation (BMT) or peripheral blood stem cell transplantation (PBSCT; n=11), and the dose of PSL was tapered off after 22 days. Oral BDP alone was administered in patients undergoing cord blood stem cell transplantation (CBSCT; n=4). The primary endpoint was the rate of treatment success on day 49, as measured according to the improvement or complete resolution of GI symptoms without additional treatment. The secondary endpoints included treatment-related toxicity according to the National Cancer Institute Common Toxicity Criteria version 3.0, the rate of treatment discontinuation due to toxicity, the rate of relapse of acute GVHD by day 100 and the incidence of bacterial, fungal or viral infection, including cytomegalovirus (CMV) antigenemia.
  
  
  RESULTS
  Treatment success was achieved in seven of the 11 (64%) patients undergoing BMT or PBSCT and in all four patients (100%) undergoing CBSCT. Subsequent adverse events included herpes zoster infection, catheter-associated sepsis and CMV enteritis; all affected patients responded well to treatment.
  
  
  CONCLUSIONS
  The use of a risk-stratified treatment strategy with oral BDP depending on the stem cell source is effective in patients with mild GI-GVHD.
authors.affiliation: Department of Medicine and Biosystemic Science, Graduate School of Medical Sciences, Kyushu University, Japan.
authors.forename: Shuichiro
authors.initials: S
authors.lastname: Takashima
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Eto
authors.forename: Motoaki
authors.initials: M
authors.lastname: Shiratsuchi
authors.forename: Michihiro
authors.initials: M
authors.lastname: Hidaka
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Mori
authors.forename: Koji
authors.initials: K
authors.lastname: Kato
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Kamezaki
authors.forename: Seido
authors.initials: S
authors.lastname: Oku
authors.forename: Hideho
authors.initials: H
authors.lastname: Henzan
authors.forename: Ken
authors.initials: K
authors.lastname: Takase
authors.forename: Takamitsu
authors.initials: T
authors.lastname: Matsushima
authors.forename: Katsuto
authors.initials: K
authors.lastname: Takenaka
authors.forename: Hiromi
authors.initials: H
authors.lastname: Iwasaki
authors.forename: Toshihiro
authors.initials: T
authors.lastname: Miyamoto
authors.forename: Koichi
authors.initials: K
authors.lastname: Akashi
authors.forename: Takanori
authors.initials: T
authors.lastname: Teshima
mesh_terms: D000328:Adult; D000368:Aged; D001507:Beclomethasone / Q000008:administration & dosage*; D016026:Bone Marrow Transplantation / Q000009:adverse effects; D036101:Cord Blood Stem Cell Transplantation / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D005767:Gastrointestinal Diseases / Q000188:drug therapy* / Q000209:etiology; D005938:Glucocorticoids / Q000008:administration & dosage*; D006086:Graft vs Host Disease / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects; D011241:Prednisone / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D001507:Beclomethasone; D011241:Prednisone