Tarantino Paolo, Trapani Dario, Morganti Stefania, Ferraro Emanuela, Viale Giulia, D'Amico Paolo, Duso Bruno Achutti, Curigliano Giuseppe
Division of Early Drug Development for Innovative Therapies, IEO, European Institute of Oncology IRCCS, Milan 20141, Italy.
Department of Oncology and Haematology (DIPO), University of Milan, Milan 20122, Italy.
Cancer Drug Resist. 2019 Mar 19;2(1):43-52. doi: 10.20517/cdr.2018.22. eCollection 2019.
Cancer drug development is a time and resources consuming process. Around 90% of drugs entering clinical trials fail due to lack of efficacy and/or safety issues, more often after conspicuous research and economic efforts. Part of the discarded drugs might be beneficial only in a subgroup of the study patients, and some adverse events might be prevented by identifying those patients more vulnerable to toxicities. The implementation of pharmacogenomic biomarkers allows the categorization of patients, to predict efficacy and toxicity and to optimize the drug development process. Around seventy FDA approved drugs currently present one or more genetic biomarker to keep in consideration, and with the progress of Precision Medicine tailoring therapies on individuals' genomic landscape promises to become a new standard of cancer care. In the current article we review the role of pharmacogenomics in cancer drug development, underlying the advantages and challenges of their implementation.
癌症药物研发是一个耗费时间和资源的过程。进入临床试验的药物中,约90%因缺乏疗效和/或安全性问题而失败,通常是在投入大量研究和经济成本之后。部分被淘汰的药物可能仅对研究患者中的一个亚组有益,通过识别那些更容易出现毒性的患者,一些不良事件可能会得到预防。药物基因组生物标志物的应用能够对患者进行分类,预测疗效和毒性,并优化药物研发过程。目前,美国食品药品监督管理局(FDA)批准的约70种药物都存在一个或多个需要考虑的基因生物标志物,随着精准医学的发展,根据个体基因组情况量身定制治疗方案有望成为癌症治疗的新标准。在本文中,我们回顾了药物基因组学在癌症药物研发中的作用,强调了其应用的优势和挑战。