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Retinoids are modulators of epithelial cell differentiation both in vivo and in vitro that are thought to act on nuclear receptors to regulate both cellular growth and differentiation and cell apoptosis Isotretinoin has been shown to suppress leukoplakia, a premalignant lesion of the aerodigestive tract Effectiveness and tolerability of low doses of isotretinoin have been demonstrated In a randomized maintenance trial, only patients with a demonstrated response to high-dose induction (15 mg/kg/ d) were placed on low-dose maintenance therapy (05 mg/kg/ d) The disease progression rate was only 8% compared with a rate of 55% in a separate group taking -carotene Three large randomized trials were performed to assess the preventive effects of retinoids on second primary tumors The first trial (Euroscan) studied 2 years of treatment with retinyl palmitate and acetylcysteine in over 2500 patients with either lung cancer or head and neck cancer No differences were found in the incidence of second primary tumors A US intergroup trial studied the use of isotretinoin to prevent second primary tumors following definitive therapy of stage I non-small cell lung cancer Because of side effects seen with the higher (50- to 100-mg) dose, the drug was given at a dosage of 30 mg/d for 3 years After a median follow-up of 35 years, there was no difference in time to second primary tumor, recurrence, or mortality Subset analysis suggested that never-smokers might benefit from isotretinoin, whereas there was a higher risk of cancer recurrence and mortality in smokers in the isotretinoin arm The major toxicity at higher doses includes skin dryness, cheilitis, hypertriglyceridemia, and conjunctivitis These toxicities require dose reduction or temporary discontinuation of the drug The third doubleblind randomized study demonstrated only a transient protective effect on local recurrence in patients definitively treated for stage I or stage II head and neck cancer A number of trials have confirmed a significantly higher rate of second primary tumor formation in smokers versus former smokers or never-smokers as well as a significant adverse effect on survival prospectively proving the impact of active smoking on second primary tumor development An interesting recent report suggests that nicotine may suppress the antigrowth effects of retinoids in lung cancer cells Retinoids have been synthesized that may be more potent chemopreventive agents with less side effects The acyclic retinoid polyprenoic acid inhibits chemically induced hepatocarcinogenesis in rats and spontaneous hepatomas in mice In patients with hepatocellular carcinoma, the rate of recurrent and second primary tumors is high despite curative therapy with surgical resection and ethanol injection therapy In one study, 89 patients who were free of disease after either method of treatment were randomized to receive either 600 mg/d of polyprenoic acid or placebo for 12 months After a median follow-up of 38 months, 27% of patients in the polyprenoic acid group versus 49% of the patients in the placebo group had recurrent or new hepatocellular carcinomas, a result that was statistically significant The difference was even greater in.

Chemoprevention focuses on the prevention of cancer by administering chemical compounds that interfere with the multistaged carcinogenic process Better understanding of the biochemical and molecular mechanisms of carcinogenesis has made possible the identification of potential chemopreventive agents Four risk groups have been identified for intervention: (1) previous cancer patients (to prevent second malignancies), (2) patients with preneoplastic lesions, (3) patients at high risk for malignancy (family history, lifestyle, occupation), and (4) the general population Chemicals used in chemoprevention must be nontoxic and well tolerated by otherwise asymptomatic individuals Because of the long natural history of carcinogenesis, there must also be a method of evaluating the efficacy of chemopreventive agents other than waiting for the development of tumors Biomarkers, including the premalignant markers such as leukoplakia, colonic polyps, and aberrant crypt formation in the colon, are currently in clinical use Other less specific surrogate markers for cancer risk such as breast density are also in use as primary end points in prevention studies Retinoids, the natural derivatives and synthetic analogs of vitamin A, are the best-studied chemopreventive agents Nonsteroidal anti-inflammatory drugs (NSAIDs) specifically, the selective cyclooxygenase (COX)-2 inhibitors and hormonal agents such as tamoxifen, raloxifene, and finasteride appear to have an important role in prevention of some cancers Numerous additional investigations include the role of specific dietary components such as vitamins and of pharmaceutical agents such as the statins Ongoing research in this area is assessing the impact and appropriate use of selective

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Weissfeld JL et al; PLCO Project Team Flexible sigmoidoscopy in the PLCO cancer screening trial: results from the baseline screening examination of a randomized trial J Natl Cancer Inst 2005 Jul 6;97(13):989 97 [PMID: 15998952]

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