title: Substantial activity of budesonide in patients with irinotecan (CPT-11) and 5-fluorouracil induced diarrhea and failure of loperamide treatment.
abstract: BACKGROUND
  Diarrhea is one of the most disturbing effects of chemotherapy, affecting quality of life on the one hand and limiting applicable doses on the other. Irinotecan (CPT-11) and 5-fluorouracil (5-FU) are associated with an elevated risk of developing severe diarrhea. Standard therapy consists of high-dose loperamide, but is associated with frequent failure. Other therapeutic regimens are still experimental. Endoscopic examination of a patient with severe loperamide-resistant diarrhea after CPT-11 chemotherapy revealed an inflammation of the ileo-coecal region. Oral therapy with the topical corticosteroid budesonide was immediately effective. This led to a phase I study of budesonide in CPT-11- and 5-FU-induced and loperamide-refractory diarrhea.
  
  
  METHODS
  Fourteen patients with CPT-11- and seven patients with 5-FU-induced grade 3-4 (NCI/WHO) diarrhea and loperamide failure were enrolled in this study. All patients had metastatic colorectal cancer.
  
  
  RESULTS
  In 86% of the CPT-11- and 57% of the 5-FU-treated patients with grade 3-4 diarrhea and loperamide failure, treatment with budesonide resulted in a reduction of diarrhea severity by at least two grades.
  
  
  CONCLUSIONS
  The orally administered topical active steroid budesonide is highly effective in the therapy of loperamide-refractory chemotherapy (CPT-11 or 5-FU)-induced diarrhea.
authors.affiliation: Department of Medicine (Gastroenterology/Medical Oncology/Endocrinology), Staedtische Kliniken Dortmund, Germany. bekelenfers@t-online.de
authors.forename: B H
authors.initials: BH
authors.lastname: Lenfers
authors.forename: T M
authors.initials: TM
authors.lastname: Loeffler
authors.forename: C M
authors.initials: CM
authors.lastname: Droege
authors.forename: T U
authors.initials: TU
authors.lastname: Hausamen
mesh_terms: D000284:Administration, Oral; D000287:Administration, Topical; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects; D019819:Budesonide / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives; D003967:Diarrhea / Q000139:chemically induced / Q000188:drug therapy*; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects; D005938:Glucocorticoids; D006801:Humans; D000077146:Irinotecan; D008139:Loperamide / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D017211:Treatment Failure
chemical_list: D000893:Anti-Inflammatory Agents; D000972:Antineoplastic Agents, Phytogenic; D005938:Glucocorticoids; D019819:Budesonide; D008139:Loperamide; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin