There are over a dozen of approved cancer drugs, whose administration is tailored to predictive laboratory
tests. The examples include estrogen and progesterone receptor status determination for the use of endocrine
therapy, HER2 assessment for the administration of HER2-targeting agents, EGFR and ALK gene testing for lung
cancer treatment, BRAF analysis in melanoma, etc. While first predictive tests relied on relatively easy laboratory
procedures, more recent developments require rather sophisticated assays. For example, administration of PARP
inhibitors is tailored to a comprehensive testing of BRCA1 and BRCA2 genes, and is likely to be supplemented in
the future by even more systematic assessment of DNA repair pathways. The detection of an androgenindependent
splice-variant of androgen-receptor (AR-V7) in castration-resistant prostate cancer is achieved
through the isolation of circulating tumor cells (CTCs). The efficacy of immune check-point inhibitors correlates
with the overall mutational tumor load, therefore the companion diagnostic assays may involve genome-wide
scanning. Integration of next-generation sequencing (NGS) into clinical oncology is expected to boost the use of
predictive tests in the forthcoming years.
Keywords: Predictive markers, cancer therapy, cytotoxic therapy, targeted therapy, mutation, expression.
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