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the groups that had secondary hepatomas At a median of 62 months of follow-up, 75% of the treatment group versus 45% of the placebo group are alive Toxicity was quite modest (headache, nausea), with none of the side effects usually described with isotretinoin Three strategies that have been proved to prevent liver carcinogenesis are vaccination against hepatitis B, treatment of chronic active hepatitis C with interferon, and deletion of premalignant and latent malignant cells in the remnant livers of patients undergoing complete resection of hepatocellular carcinomas The retinamide fenretinide (4-HPR) is a potent apoptosisinducing synthetic vitamin A analog with significant in vitro activity Fenretinide appears to reduce the activity of telomerase, which is important in lung carcinogenesis Expression of telomerase reverse transcriptase (TERT), the catalytic subunit of telomerase, was evaluated on bronchial biopsies in 57 heavy smokers before and after 6 months of treatment with fenretinide or placebo A 25% reduction in expression of TERT was found in the fenretinide-treated patients Although clinical follow-up is clearly critical, the hope is that this type of surrogate marker will improve our ability to assess the effectiveness of possible chemopreventive agents and perhaps also identify patients at higher risk for cancer development Fenretinide is being studied in randomized trials as a chemopreventive agent in patients with superficial bladder cancer and in women at increased risk for ovarian cancer Newer and more potent retinoids are being developed and tested for use in a variety of cancers

Aspirin and other NSAIDs inhibit tumor growth in experimental systems In rats, prostaglandin inhibitors reduce the size and number of colon tumors induced by chemicals or radiation by inhibiting COX activity in the arachidonic acid pathway (COX-1 and COX-2) Regular aspirin administration at low doses (16 or more doses of 325 mg per month for at least 1 year) may reduce the risk of fatal colon cancer by as much as 40 50% Low-dose aspirin may also protect against cancers of the esophagus, stomach, and rectum In patients with familial adenomatous polyposis (FAP), sulindac has been shown to reduce the number and the size of colorectal adenomas, although the effect is incomplete and is not maintained when the drug is discontinued A large prospective cohort study was subsequently published evaluating aspirin use and the risk for both colorectal cancer and adenoma in 48,000 male health professionals over a 4-year period The subsequent risk of developing colorectal cancer and adenomas was lower in men reporting regular use of aspirin (250 mg more than twice a week) even when multiple other variables were taken into account In the Nurses Health Study, 90,000 women were evaluated for the risk of colorectal cancer over a 12-year period according to the number of consecutive years of regular aspirin use (two or more 325-mg tablets per week) There was a statistically significant decrease in the risk of colorectal cancer after 20 years of consistent aspirin use, with the maximal reduction seen in women who took four to six tablets per week Known risk factors such as diet did not influence this risk reduction The Physicians Health Study is the only randomized prospective trial of

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aspirin (325 mg every other day for 5 years) versus placebo Unfortunately, this study showed no difference in the frequency of self-reported new colorectal cancers The selective COX-2 enzyme inhibitors have been the subject of intense research in the area of prevention and treatment of cancer COX-2 expression is inducible, unlike the constitutive expression of COX-1, and COX-2 up-regulation occurs in most epithelial tumors, including colorectal cancer and cancers of the lung and breast This up-regulation is thought to be secondary to other initiating events, such as oncogene activation or mutation of a tumor suppressor gene COX-2 levels increase throughout oncogenesis, and expression appears to promote angiogenesis (new blood vessel growth) and decrease apoptosis (programmed cell death); overexpression correlates with worse outcomes including shorter remission durations and survival One selective COX2 inhibitor, celecoxib, has been shown to induce regression of polyps in patients with FAP at a dosage of 400 mg twice a day for 6 months Based on these data, celecoxib was approved by the Food and Drug Administration (FDA) for chemoprevention of polyps in patients with FAP Up until recently, the primary known side effect of COX-2 inhibitors was thought to be gastrointestinal bleeding However, in September 2004, a study evaluating rofecoxib found an increased incidence of cardiovascular events, including death, in patients taking the medication for 18 months or more Subsequent data have confirmed an increase in cardiovascular risk for all the COX2 inhibitors, including celecoxib and valdecoxib Unfortunately, this apparent class effect of the selective COX-2 inhibitors limits their possible use as chemopreventive agents; multiple national trials focusing on either prevention or treatment of cancer were subsequently either closed or redesigned to eliminate the arms containing celecoxib Clearly, new agents targeting COX-2 need to be developed that better fit the criteria for safe chemopreventive agents

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