title: Gastroduodenal mucosal injury during hepatic arterial infusion of chemotherapeutic agents. Lack of cytoprotection by prostaglandin E1 analogue.
abstract: Eighteen colorectal cancer patients with liver metastases receiving hepatic arterial infusion of chemotherapeutic agents (mitomycin-C + 5-FUDR) were randomized to receive misoprostol (a prostaglandin E1 analogue) or placebo as a mode of cytoprotection against inadvertent gastroduodenal mucosal injury. Four of 10 patients on misoprostol and 3 of 8 patients on placebo developed gastroduodenal mucosal injury (p greater than 0.1), which was confirmed by endoscopy. Significant tumor responses to chemotherapy were equally distributed between the two groups. Although our sample size was small and type II error (false-negative trial) cannot be excluded, these data strongly suggest that prophylaxis with misoprostol does not prevent the acute gastroduodenal mucosal injury associated with hepatic arterial infusion of chemotherapeutic agents.
mesh_terms: D000527:Alprostadil / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005467:Floxuridine / Q000008:administration & dosage; D005753:Gastric Mucosa / Q000187:drug effects*; D006499:Hepatic Artery; D006801:Humans; D007261:Infusions, Intra-Arterial; D007413:Intestinal Mucosa / Q000187:drug effects*; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D016595:Misoprostol; D016685:Mitomycin; D008937:Mitomycins / Q000008:administration & dosage; D011897:Random Allocation
chemical_list: D008937:Mitomycins; D005467:Floxuridine; D016595:Misoprostol; D016685:Mitomycin; D000527:Alprostadil