A group of Texas researchers recently reported evidence to support the claim that the drug celecoxib reduces the number of colorectal growths, or polyps, that develop in persons with familial adenomatous polyposis. Persons with this disease typically develop hundreds of those polyps, greatly increasing their risk for developing colorectal cancer at an early age.

Cancers of the colon and rectum, sometimes referred to together as colorectal cancer, are characterized by the presence of cancerous tumors in the colon or rectum, each part of the body’s digestive system. Non-cancerous tumors, called adenomatous polyps, may also grow in the colon or rectum, and these polyps eventually become cancerous in some persons, developing into colorectal cancer.

Familial adenomatous polyposis (FAP) is a genetic disease that most often affects adolescents and young adults, causing hundreds of adenomatous polyps to form in the colon and rectum. Because of the presence of these polyps, many of these persons develop colorectal cancer at an early age. The treatment is usually surgery to remove existing polyps and careful monitoring for and removal of the polyps as they continue to develop.

Recently, the Food and Drug Administration approved a drug called celecoxib, a nonsteroidal anti-inflammatory drug previously approved for the treatment of persons with arthritis, to be used in conjunction with the usual therapy for persons with FAP. Celecoxib has been reported to reduce the number of polyps that develop in persons with FAP, thus significantly reducing their risk for developing colorectal cancer. Recently, researchers from Texas sought to determine how effective celecoxib is in reducing polyps in persons with this disease.

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Researchers assigned 77 persons with FAP to receive either celecoxib or a placebo for 6 months. Some patients taking the celecoxib received a dose of 100mg twice daily, while others received 400mg twice daily. Patients were monitored for the number and size of colorectal polyps at the beginning and end of the study. After the 6 months, the patients receiving the placebo had a reduction in the number of colorectal polyps of 4.5% and a reduction in

polyp burden (the sum of the size of all the polyps) of 4.9%. Those receiving celecoxib 100mg experienced a reduction in the number of polyps of 11.9% and in polyp burden of 14.6%. Finally, those receiving the higher dose of celecoxib had a reduction in the number of polyps of 28% and in polyp burden of 30.7%. The treatment side effects were similar in all 3 groups.

From these findings, the researchers concluded that celecoxib at 400mg, given twice daily for 6 months, dramatically reduces the number of colorectal polyps in persons with FAP. Further study is needed to determine the reduction in risk for colorectal cancer associated with this treatment regimen. Persons who have FAP may wish to talk with their doctor about the risks and benefits of receiving celecoxib or of participating in a clinical trial (research study) in which celecoxib is being studied further. Two sources of information on ongoing clinical trials include clinical trials listing services provided by the National Cancer Institute (cancer.gov) and eCancerTrials.com. eCancerTrials.com also performs personalized clinical trial searches on behalf of patients. (New England Journal of Medicine, Vol 342, No 26, pp 1946-1952, 2000)

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