Rct

13-cis-Retinoic acid (n = 24) or placebo (n = 20), 1-2mg/kg/day for 3 months, and followed them for 6 months

Decrease in lesion size in 67% of those given the drug and in 10% of those given placebo (P = 0.0002); dysplasia reversed in 54% (13 patients) of the drug group vs. 10% (2 patients) of the placebo group (P = 0.01)

RCT, randomized controlled clinical trial.

RCT, randomized controlled clinical trial.

The Hong group also established that second primary tumors (SPTs), the leading cause of cancer-related death among individuals cured of an initial primary head and neck tumor, can be prevented by retinoid treatment. Patients definitively treated for an initial head and neck cancer showed a marked decrease in SPTs in response to a high-dose 13-CRA regimen for 1 year.51 However, significant side effects were associated with the high-dose 13-CRA treatment. Also, the effectiveness of the retinoid treatment diminished over time; in fact, the SPT rate by 3 years after cessation of 13-CRA treatment was the same as the placebo group.52 A follow-up study of the effect of low-dose 13-CRA for 3 years for preventing SPTs is nearing completion.53 Again, linking laboratory studies with these clinical trials has proven beneficial. For example, Hong, in collaboration with Margaret Spitz and colleagues, showed that susceptibility of peripheral blood lymphocytes to chromosomal breaks induced by the mutagens bleomycin or benzo[a]pyrene diol epoxide is an independent risk factor for head and neck cancer.54,55 The mutagen-sensitive phenotype has also been shown to be a significant predictor of SPT risk.56 Thus, the Hong group illustrates the model of the multidisciplinary approach to cancer prevention that takes advantage of conducting basic research on biomarkers and clinical research on pharmacokinetics of the agent in the prevention of OPL and SPT. This model is elaborated in Figure 23.2.

FIGURE 23.2. The transdisciplinary nature of evidence-based cancer prevention research. Research progress in the principles and practice of cancer prevention will increasingly require the integration of observational epidemiologic and clinical findings, the development and use of relevant animal models, the characterization of basic mechanisms at the molecular and cellular level, and the ultimate test of an hypothesis in clinical research.

FIGURE 23.2. The transdisciplinary nature of evidence-based cancer prevention research. Research progress in the principles and practice of cancer prevention will increasingly require the integration of observational epidemiologic and clinical findings, the development and use of relevant animal models, the characterization of basic mechanisms at the molecular and cellular level, and the ultimate test of an hypothesis in clinical research.

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