Clinical Implementation of Germ Line Cancer Pharmacogenetic Variants During the Next-Generation Sequencing Era

More than 100 medications approved by the US Food and Drug Administration include pharmacogenetic biomarkers in the drug label, many with cancer indications referencing germ line DNA variations. With the advent of next‐generation sequencing (NGS) and its rapidly increasing uptake into cancer researc...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2014-03, Vol.95 (3), p.269-280
Main Authors: Gillis, N K, Patel, J N, Innocenti, F
Format: Article
Language:English
Subjects:
Biological and medical sciences
Biomarkers
Cost-Benefit Analysis
Evidence-Based Medicine
Government Agencies
High-Throughput Nucleotide Sequencing - trends
Humans
Insurance, Health
Medical sciences
Multiple tumors. Solid tumors. Tumors in childhood (general aspects)
Neoplasms, Germ Cell and Embryonal - drug therapy
Neoplasms, Germ Cell and Embryonal - genetics
Pharmacogenetics - trends
Pharmacology. Drug treatments
Tumors
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Summary:More than 100 medications approved by the US Food and Drug Administration include pharmacogenetic biomarkers in the drug label, many with cancer indications referencing germ line DNA variations. With the advent of next‐generation sequencing (NGS) and its rapidly increasing uptake into cancer research and clinical practice, an enormous amount of data to inform documented gene–drug associations will be collected that must be exploited to optimize patient benefit. This review focuses on the implementation of germ line cancer pharmacogenetics in clinical practice. Specifically, it discusses the importance of germ line variation in cancer and the role of NGS in pharmacogenetic discovery and implementation. In the context of a scenario in which massive amounts of NGS‐based genetic information will be increasingly available to health stakeholders, this review explores the ongoing debate regarding the threshold of evidence necessary for implementation, provides an overview of recommendations in cancer by professional organizations and regulatory bodies, and discusses limitations of current guidelines and strategies to improve third‐party coverage. Clinical Pharmacology & Therapeutics (2014); 95 3, 269–280. doi:10.1038/clpt.2013.214
ISSN:0009-9236
1532-6535
DOI:10.1038/clpt.2013.214