Circulating tumor cells as pharmacodynamic biomarker in early clinical oncological trials.

Abstract: Circulating tumor cells (CTCs) have received a lot of attention from both researchers and clinicians because of their prognostic value for progression-free and overall survival in selected tumor types. CTCs are readily available by single venipuncture, thereby posing little burden on the patient and allowing for repeated, sequential sampling during therapy. Nowadays, the sensitivity of several CTC detection and capture techniques allow for further characterization and analysis of specific targets of interest on the CTC itself. These techniques have given CTCs the potential to be used as a pharmacodynamic read-out in drug development. In this review, we explore the utility of CTCs as a pharmacodynamic biomarker in early clinical oncological trials. We present an overview of current literature on assays for CTCs as pharmacodynamic biomarker, their different targets of interest and their level of validation, followed by discussion of their limitations. [Copyright &y& Elsevier]