Introduction: Biomarkers and imaging


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Caroline Dive
Paterson Institute for Cancer Research, Manchester, UK

Abstract

Successful development of targeted therapies for improved cancer treatment requires the implementation of pharmacodynamic (PD) and predictive biomarkers as early as possible in clinical testing. PD biomarkers (developed during preclinical drug evaluation), and applied in Phase I trials offer the opportunity for early proof of mechanism (drug hits intended target) and concept (tumour responds appropriately to drug-target hitting). Predictive biomarkers allow stratification of patients most likely to receive drug benefit, sparing those who will not from any unwanted side effects. Whilst ideally this information should derive from tumour, it is clear that in early clinical trials, provision of tumour biopsies pre and serially post therapy is often challenging. There has been some controversy around how early in clinical development a biomarker based approach should be implemented, considering the small patient numbers in Phase I trials and the diversity of tumour type that challenge statistical rigour. This issue provokes questions regarding modification of early clinical trial designs to maximise biomarker information. This symposium considers the implementation of less invasive circulating biomarkers and non invasive imaging modalities; specifically the impact, potential and limitations of circulating biomarkers of angiogenesis, circulating tumour cells and DC MRI and PET imaging as biomarkers in Phase I/II trials of mechanism based therapeutics will be explored.