At present individualised patient therapy has been a major concept and many drugs have been approved for the particular segment of patients (specific mutation), for example, ALK, EGFR mutation therapies in NSCLC, AR-V7 mutation in CRPC. Since for most of these trials use PFS, OS, ORR as primary endpoints. For oncology trials, surrogate endpoints need to predict the early efficacy. Therefore, Circulating Tumor Cells (CTC) with specific mutation can acts a surrogate endpoint.

We are very close to using CTC subgroups as biomarker to make clinical decisions, to check prognosis and early assessment of therapeutic effects. Need more clinical validation of CTCs as a surrogate biomarker. Two studies show in favour of this concept. AR-V7 mRNA Helps Pinpoint CRPC Outcomes Serial analysis of circulating tumour cells may provide biomarker predictive of lung cancer response to Crizotinib Sources :…