Pharmacogenetics- and pharmacogenomics-based rational clinical trial designs in oncology

被引：2

作者：

Qin, Rui ^{[1
]}

Kohli, Manish ^{[2
]}

机构：

[1] Mayo Clin, Dept Hlth Sci Res, Rochester, MN 55905 USA

[2] Mayo Clin, Dept Oncol, Rochester, MN 55905 USA

来源：

PERSONALIZED MEDICINE | 2013年 / 10卷 / 08期

关键词：

adaptive clinical trial; genomic signature; molecular profiling; pharmacogenetic; predictive biomarker; GENE-EXPRESSION SIGNATURE; BAYESIAN ADAPTIVE DESIGN; PROSTATE-CANCER; INCREASED SURVIVAL; CASTRATION; MITOXANTRONE; ABIRATERONE; PREDNISONE; BIOMARKERS; DOCETAXEL;

D O I：

10.2217/pme.13.78

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The rapid evolution of molecular technologies that can identify genetic markers and lead to dissecting the inherent variance of individual cancer biology has had a tangible impact on trial designs in oncology. Rational trial designs based on molecular marker expression coupled with drug-marker interactions have started to be adopted, challenging the previous paradigms of morphology-based, single-arm efficacy studies. This review summarizes novel trials being developed based on molecular predictive factor therapeutics and the potential impact these novel trial designs will have on the practice of oncology in future. A variety of clinical trial designs based on tumor and drug-host genetic interactions are discussed and the example of advanced prostate cancer is used to illustrate the changing landscape of clinical trial designs in cancer.

引用

页码：859 / 869

页数：11

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