Abstract
5159 Background: Symptoms of bowel obstruction and intermittent chronic obstruction are common complications in patients (pts) with recurrent ovarian cancer. Mechanisms of bowel obstructions include intraabdominal carcinomatosis, drug-induced intestinal immobility, and intraluminal obstruction. Octreotide inhibits gastrointestinal hormonal secretion and decreases splanchnic blood flow. Sandostatin LARDepot (LAR) is a long-acting depot form of octreotide given intramuscularly (IM) once per month. Methods: The objectives of this trial were to assess efficacy and toxicities of LAR in ovarian cancer pts with chronic or intermittent bowel obstruction. Pts must have recurrent ovarian or primary peritoneal cancer, symptoms related to a non-surgically amenable bowel obstruction, and a life expectancy of >2 months. Following a test dose of short-acting octreotide to rule out a hypersensitivity reaction, subcutaneous (SQ) octreotide was started at a dose of 100 mcg 3x/day for 2 weeks (in order to quickly achieve therapeutic serum levels) along with LAR 30 mg IM qmonth. IM LAR was given until symptom progression or toxicity. Results: Since the study began in 9/02, 15 pts have been enrolled, and the study is now completed. The mean age of pts is 57 years of age. One enrolled pt never received any study drug, and data is available on 14 pts. Of the 15 pts enrolled, 13 have died from cancer progression. 3 pts received a successful test dose and one LAR injection, but were taken off study per their request. Of the 9 pts who received >2 months of LAR, the duration of LAR ranged from 2 to >12 months with a median of 4 months. No grade 3 or 4 toxicities related to LAR were seen, and LAR was well tolerated. 2 pts had skin reactions, and 1 of these 2 pts was taken off study. QOL data was collected and will be presented at ASCO. Conclusions: LAR is well tolerated following successful administration of a test dose of SQ octreotide. In this ovarian cancer population with inoperable bowel obstruction, LAR has activity in the management of symptoms of bowel obstruction and can be used safely in this population without apparent cumulative toxicity. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Novartis
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