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Previous Volume 346:1054-1059 April 4, 2002 Number 14 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Chau, I. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Familial adenomatous polyposis is caused by a germ-line mutation in the adenomatous polyposis coli gene and is characterized by the development of hundreds of colorectal adenomas and, eventually, colorectal cancer. Nonsteroidal antiinflammatory drugs can cause regression of adenomas, but whether they can prevent adenomas is unknown.

Methods We conducted a randomized, double-blind, placebo-controlled study of 41 young subjects (age range, 8 to 25 years) who were genotypically affected with familial adenomatous polyposis but phenotypically unaffected. The subjects received either 75 or 150 mg of sulindac orally twice a day or identical-appearing placebo tablets for 48 months. The number and size of new adenomas and side effects of therapy were evaluated every four months for four years, and the levels of five major prostaglandins were serially measured in biopsy specimens of normal-appearing colorectal mucosa.

Results After four years of treatment, the average rate of compliance exceeded 76 percent in the sulindac group, and mucosal prostaglandin levels were lower in this group than in the placebo group. During the course of the study, adenomas developed in 9 of 21 subjects (43 percent) in the sulindac group and 11 of 20 subjects in the placebo group (55 percent) (P=0.54). There were no significant differences in the mean number (P=0.69) or size (P=0.17) of polyps between the groups. Sulindac did not slow the development of adenomas, according to an evaluation involving linear longitudinal methods.

Conclusions Standard doses of sulindac did not prevent the development of adenomas in subjects with familial adenomatous polyposis.

Source Information

From the Department of Medicine (F.M.G., V.W.Y., L.M.H., A.J.K., J.D.T., D.E.G., W.H.) and the Oncology Center (F.M.G., V.W.Y., S.P., E.G.), Johns Hopkins University School of Medicine, Baltimore; Mayo Clinic, Rochester, Minn. (G.M.P.); the Department of Pathology, Academic Medical Center, Amsterdam (G.J.A.O.); and the Division of Pathology and Laboratory Medicine, University of Texas M.D. Anderson Cancer Center, Houston (S.R.H.).

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Sulindac in Familial Adenomatous Polyposis
Levy R.
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N Engl J Med 2002; 347:615, Aug 22, 2002. Correspondence

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