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Annals of Oncology 10:1251-1253, 1999
© 1999 European Society for Medical Oncology


brief-report

Substantial activity of budesonide in patients with irinotecan (CPT-11) and 5-fluorouracil induced diarrhea and failure of loperamide treatment*

B. H. M. Lenfers, T. M. Loeffler, C. M. Droege and T. U. Hausamen

Department of Medicine (Gastroenterology/Medical Oncology/Endocrinology), Staedtische Kliniken Dortmund Dortmund, Germany

Correspondence to: Dr B. H. M. Lenfers, Medizinische Klinik Mitte, Gastroenterologie/Onkologie/Endokrinologie, Städtische Kliniken Dortmund, 44123 Dortmund, Germany. E-mail: bekelenfers{at}t-online.de

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 loper-amide-refractory diarrhea.

Patients and 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.

budesonide, chemotherapy-induced diarrhea, CPT-11, 5-fluorouracil, irinotecan


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