Assessing efficacy in early-phase cancer prevention clinical trials: the case of ki-67 in the lung.
This perspective on Kim et al. (beginning on p. 148 in this issue of the journal) examines the value of the Ki-67 proliferation index as a surrogate end point in early-phase clinical lung cancer prevention trials. The clinical trial of Kim et al. shows an effect of the cyclooxygenase-2-selective inhibitor celecoxib at a high dose on Ki-67 expression in the normal bronchial epithelia of current and former smokers. The critical issue of how these data can be used to further drug development is discussed.
Szabo
Eva
E
Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, NIH, Department of Health and Human Services, Bethesda, Maryland 20892, USA. szaboe@mail.nih.gov
D000970:Antineoplastic Agents / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000032:analysis*; D000068579:Celecoxib; D002986:Clinical Trials as Topic; D006801:Humans; D019394:Ki-67 Antigen / Q000187:drug effects*; D008175:Lung Neoplasms / Q000517:prevention & control*; D011720:Pyrazoles / Q000627:therapeutic use; D020545:Respiratory Mucosa / Q000187:drug effects*; D013449:Sulfonamides / Q000627:therapeutic use
D000970:Antineoplastic Agents; D014408:Biomarkers, Tumor; D019394:Ki-67 Antigen; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib