CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
RESEARCH SUPPORT, NON-U.S. GOV'T
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Multicenter prospective study on efficacy and safety of octreotide for inoperable malignant bowel obstruction.

OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of octreotide for malignant bowel obstruction in a multicenter study.

METHODS: Terminally ill patients diagnosed with inoperable malignant bowel obstruction were treated with octreotide 300 microg/day. The primary endpoint was the overall improvement rate of subjective abdominal symptoms. The degrees of nausea, vomiting, abdominal pain, distension, anorexia, fatigue, thirst and overall quality of life were evaluated by the self-rating scores selected from the MD Anderson Symptoms Inventory and Kurihara's Face Scale.

RESULTS: Forty-nine patients were enrolled in the study, and 46 patients received study treatment, including 17 gastric, 13 colorectal, 7 ovarian and other cancers. The median survival time was 25 days. The number of vomiting episodes significantly correlated with the MD Anderson Symptoms Inventory nausea and vomiting scores (P< 0.001) before octreotide treatment. Of 43 patients evaluable for efficacy, the scores of all the MD Anderson Symptoms Inventory items except abdominal pain and the number of vomiting episodes improved during the first 4 days of octreotide treatment (P< 0.0062). The MD Anderson Symptoms Inventory scores were decreased in 59-72% of patients, and overall quality-of-life scores improved in 56% of patients. No serious adverse events were observed.

CONCLUSIONS: The high improvement rate in abdominal symptoms suggested the efficacy of octreotide in terminally ill patients with malignant bowel obstruction.

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