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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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  • 1Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, NIH, Department of Health and Human Services, Bethesda, Maryland 20892, USA.


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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