Qin Rui, Kohli Manish
Department of Health Sciences Research, Mayo Clinic, 200 First Street South West, Rochester, MN 55905, USA.
Department of Oncology, Mayo Clinic, 200 First Street South West, Rochester, MN 55905, USA.
Per Med. 2013 Nov;10(8):859-869. doi: 10.2217/pme.13.78.
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.
能够识别基因标记并有助于剖析个体癌症生物学内在差异的分子技术的迅速发展，已对肿瘤学试验设计产生了切实影响。基于分子标记表达以及药物与标记相互作用的合理试验设计已开始被采用，这对以往基于形态学的单臂疗效研究模式提出了挑战。本综述总结了基于分子预测因子疗法正在开展的新型试验，以及这些新型试验设计未来对肿瘤学实践可能产生的影响。文中讨论了基于肿瘤与药物-宿主基因相互作用的多种临床试验设计，并以晚期前列腺癌为例来说明癌症临床试验设计的不断变化情况。
