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Anti-inflammatory drug fails to prevent a hereditary colon cancer

The anti-inflammatory drug sulindac may not have the colon cancer prevention properties once hoped for, say Johns Hopkins Kimmel Cancer Center researchers. Results of a four-year study, described in the April 4, 2002 issue of the New England Journal of Medicine, show that sulindac did not prevent precancerous growths, called polyps, in young patients with a hereditary form of colon cancer. The drug may still have benefit in reducing polyps in older patients.

Researchers followed 41 patients ages eight to 25 with known genetic mutations that result in a form of hereditary colon cancer, called familial adenomatous polyposis (FAP) or Gardner syndrome, who had not begun to develop polyps. FAP patients develop, on average, hundreds of polyps in their colon and rectum by age 15, and virtually always develop colon cancer, often by their early 30s or sooner.

Twenty-one patients took standard doses (75 to 150 mg) of sulindac twice daily and 20 patients were given a placebo. Nine of 21 (43 percent) patients taking sulindac and 11 of 20 patients (55 percent) taking a placebo developed polyps. Three of the sulindac recipients developed colon cancer. Diaries, pill counts, biopsies of the colon, and colonoscopies verified that patients took their pills and evaluated the number and size of new polyps.

"Despite prior evidence that sulindac is effective in older, symptomatic patients, investigators found no statistical difference between the two groups in thwarting the development of polyps or subsequent colon cancer," concludes Frank Giardiello, M.D., division director of gastroenterology/hepatology, professor of medicine and oncology, and director of the study.

"In medicine, learning what doesn't work is just as important as learning what does work," adds Giardiello. "Prior studies indicated that sulindac can reduce polyps in older, symptomatic FAP patients, but whether it could prevent polyps in FAP patients who hadn't developed any poly
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Contact: Vanessa Wasta
wastava@jhmi.edu
410-955-1287
Johns Hopkins Medical Institutions
3-Apr-2002


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