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Chemoprevention backgrounder: Working for a future of cancer chemoprevention

>Yet another trial, led by Lynch, will be evaluating the efficacy of celecoxib in children who are carriers of the mutated FAP gene, and who have little or no evidence yet of polyps. This international study will follow the recently completed pediatric phase I trial conducted by Lynch and colleagues at the Cleveland Clinic.

Levin is researching the issue as co-principal investigator of a multi-center international trial of celecoxib, evaluating its role in preventing recurrence of precancerous polyps.

Researchers say that any drug used for a long time has to be proven to be safe, and that is equally true for the popular COX-2 inhibitors, which are most often used to treat arthritis and pain. For example, a different COX-2 inhibitor drug known as Vioxx was withdrawn from the market in September, 2004, because it doubled cardiovascular problems in a clinical trial testing if it could prevent colon polyp recurrence. Clinical trials such as Levin's that is testing celecoxib, also as a chemopreventive against recurrence of large polyps, have not been halted although data is being intensely scrutinized by cardiovascular experts for similar problems to assure long-term patient safety.

Aspirin, which also has the properties of a COX-2 inhibitor, has itself shown that it may help prevent colon cancer. A study published last year in The New England Journal of Medicine showed that a low-dose baby aspirin proved effective as a modest colon cancer chemopreventive, reducing the number of precancerous polyps by 19 percent.

Results from the prospective, randomized clinical trial of more than 1,000 participants, offered "the strongest indication to date that aspirin can have a significant effect on recurrence of colon adenomas," says one of the study's lead researchers, Robert Bresalier, M.D., professor and chair of the Department of Gastrointestinal Medicine and Nutrition at M. D. Anderson.

Surprisingly, the study found that the effect of a
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Contact: Nancy Jensen
nwjensen@mdanderson.org
713-792-0655
University of Texas M. D. Anderson Cancer Center
16-Nov-2004


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