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Cancer Prev Res (Phila). 2010 Feb;3(2):128-31. doi: 10.1158/1940-6207.CAPR-09-0268. Epub 2010 Jan 26.

Assessing efficacy in early-phase cancer prevention clinical trials: the case of ki-67 in the lung.

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  • 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


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.

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