title: Assessing intraepithelial neoplasia and drug safety in cancer-preventive drug development.
abstract: Despite significant interest from the research community and the population in general, drug approvals for cancer prevention and/or cancer risk reduction are few. This is due, in part, to the requirement that new cancer-preventive drugs must first be shown to be efficacious in reducing cancer incidence or mortality. Moreover, such drugs need to have proven safety for long-term administration. This process can be improved by focusing on precancer (intraepithelial neoplasia) to identify subjects at risk and prove efficacy in shorter, smaller trials as well as on detecting early markers of potential toxicities of chronic exposure to cancer-preventive drug regimens.
authors.affiliation: National Institutes of Health, National Cancer Institute, Division of Cancer Treatment and Diagnosis, Executive Plaza North Room 6058, 6130 Executive Boulevard, Rockville, Maryland 20852, USA. kelloffg@mail.nih.gov
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Kelloff
authors.forename: Caroline C
authors.initials: CC
authors.lastname: Sigman
mesh_terms: D016588:Anticarcinogenic Agents / Q000627:therapeutic use*; D002278:Carcinoma in Situ / Q000453:epidemiology / Q000235:genetics / Q000517:prevention & control*; D006801:Humans; D011230:Precancerous Conditions / Q000473:pathology / Q000517:prevention & control; D040242:Risk Reduction Behavior; D012449:Safety
chemical_list: D016588:Anticarcinogenic Agents