Abstract
Early phase clinical trials are an essential component of chemopreventive drug development to identify signals of drug efficacy that can subsequently be explored definitively in phase III trials. Whereas phase I trials focus on safety and identification of optimal dose and schedule for cancer prevention, phase II trials focus on intermediate endpoints that are variably related to cancer development. The United States National Cancer Institute supports a programme devoted to early phase cancer prevention clinical trials. The experience, along with the benefits and limitations of the range of biomarker endpoints used in these studies, are reviewed here.
Highlights
The development of epithelial cancer is a lengthy process that provides multiple opportunities for intervention
Selection of biomarker endpoints for early phase chemoprevention clinical trials is driven by a balance between feasibility and the amount of information to be obtained from modulation of that biomarker
The more causally linked the biomarker is to cancer development, the more informative it is with regard to subsequent drug development
Summary
The development of epithelial cancer is a lengthy process that provides multiple opportunities for intervention. Molecular profiling, resulting in treatment with targeted therapies based on the presence of specific molecular abnormalities, has become a part of standard care in several diseases even as the full potential of immunotherapy is just starting to be understood [1, 2]. The longest phase of carcinogenesis is likely to be the premalignant phase, starting with the first initiating mutations through increasing levels of molecular and histologic abnormalities that culminate in the breach of the basement membrane and local invasion [3]. The lengthy time frame and less complex molecular profiles (at least early on) of the premalignant disease phase make it a attractive target for intervention
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