Biomarkers: Intermediate endpoints for upper aerodigestive tract chemoprevention trials

Chemoprevention trials seek to interrupt carcinogenesis through the administration of drugs before the development of invasive cancer. Current research includes efforts not only to develop effective chemoprevention regimens, but also to establish reliable intermediate markers that may be used as clinical trial endpoints. The use of biomarkers as intermediate endpoints would greatly improve the efficiency of these trials. In the upper aerodigestive tract (UADT), several candidate biomarkers have been described and may be characterized as genomic, proliferation, and differentiation markers. These potential intermediate endpoints include micronuclei, oncogenes, proliferating cell nuclear antigens, blood group antigens, and keratins. Evaluation of these biomarkers as intermediate endpoints is a component of all current UADT chemoprevention trials at our institution.