Abstract
Given the interpatient biological heterogeneity and narrow therapeutic index of anticancer drugs, a practical method for personalizing cancer therapy is essential. Genotype-guided cancer therapy will provide an optimal approach to normalize systemic drug exposures, predict drug toxicities and/or enrich clinical efficacy. To date, over a dozen anticancer drugs approved by the US FDA require labeling regarding pharmacogenetic biomarkers (both germline and somatic). Many, but not all, have prospective, genotype-guided evidence-based data. Optimizing output from retrospective, prospective, cost–effectiveness and adaptive biomarker driven clinical trials will help drive the success of personalized cancer therapy. This review will discuss prospective genotype-guided clinical trials in patients with solid tumors and address barriers in clinical translation.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.