Early-Phase Interventional Trials in Oral Cancer Prevention

McCarthy, Caroline, Fedele, Stefano, Ottensmeier, Christian ORCID: 0000-0003-3619-1657 and Shaw, Richard J ORCID: 0000-0002-5157-4042 (2021) Early-Phase Interventional Trials in Oral Cancer Prevention. CANCERS, 13 (15). 3845-.

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Official URL: http://dx.doi.org/10.3390/cancers13153845

Abstract

The increasing breadth of molecular targets, promise of immune-targeted therapies and repurposed agents have heightened interest in cancer prevention. While, to date, testing of oral cancer chemoprevention strategies has failed to deliver therapeutic agents for routine clinical practice, there remains an urgent need for further clinical research to overcome this hurdle. Patients at the greatest risk of disease stand to benefit the most from inclusion in clinical trials; therefore, there is a need to carefully define this population using validated clinical and molecular markers. Safety, tolerability and the efficacy of interventions is assessed through carefully selected endpoints. These endpoints may include pharmacodynamic, clinical, histological and on-target molecular modifications as an individual or as a composite endpoint. Early-phase trials provide an area of opportunity to explore novel and repurposed agents in the setting of oral cancer chemoprevention, eventually leading to phase III trials with clinical endpoints such as transformation and clinical outcome; these studies are large, lengthy and expensive and should be reserved for the most promising of agents. This paper will explore current evidence in oral cancer chemoprevention, drug repurposing, selection of appropriate endpoints for early-phase trials and novel therapeutic angles in oral cancer chemoprevention.

Item Type:	Article
Uncontrolled Keywords:	oral epithelial dysplasia, chemoprevention, early-phase trials, oral cancer prevention, phase I, phase II, first-in-human
Divisions:	Faculty of Health and Life Sciences Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User:	Symplectic Admin
Date Deposited:	22 Dec 2021 09:29
Last Modified:	18 Jan 2023 21:18
DOI:	10.3390/cancers13153845
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3145796