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Journal of the National Cancer Institute Advance Access originally published online on October 30, 2007
JNCI Journal of the National Cancer Institute 2007 99(21):1565-1567; doi:10.1093/jnci/djm206
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Published by Oxford University Press 2007.

EDITORIALS

Proliferative Changes in Chemoprevention Trials: Learning From Secondary Endpoints

Eva Szabo

Correspondence to: Eva Szabo, MD, Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, Room 2137, 6130 Executive Blvd, Bethesda, MD 20852 (e-mail: szaboe@mail.nih.gov).

The first 10% of the full text of this article appears below.

Despite the successful demonstration of cancer preventive efficacy exemplified by agents such as tamoxifen and raloxifene for breast cancer, development of chemopreventive agents remains a difficult and challenging endeavor (1,2). Among the more daunting of the challenges is the identification of effective agents in early-phase clinical trials, before the sizable investment of resources required for phase III studies has occurred. The demonstration of preliminary efficacy requires not only an effective agent that is delivered appropriately for long enough to be effective but also the use of informative endpoints that predict the true endpoint of decreased cancer incidence. Whereas cancer treatment trials use surrogates such as tumor shrinkage to identify promising agents in phase II trials, cancer prevention trials seek to forestall the occurrence of future events (e.g., cancer). The . . . [Full Text of this Article]


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