Simon Richard
Richard Simon, DSc, National Cancer Institute, Rockville MD.
J Natl Cancer Inst. 2015 Jun 24;107(8). doi: 10.1093/jnci/djv153. Print 2015 Aug.
Molecularly targeted cancer drugs are often developed with companion diagnostics that attempt to identify which patients will have better outcome on the new drug than the control regimen. Such predictive biomarkers are playing an increasingly important role in precision oncology. For diagnostic tests, sensitivity, specificity, positive predictive value, and negative predictive are usually used as performance measures. This paper discusses these indices for predictive biomarkers, provides methods for their calculation with survival or response endpoints, and describes assumptions involved in their use.
分子靶向抗癌药物通常与伴随诊断一起开发,这些伴随诊断旨在识别哪些患者使用新药比使用对照方案会有更好的疗效。此类预测性生物标志物在精准肿瘤学中发挥着越来越重要的作用。对于诊断测试,敏感性、特异性、阳性预测值和阴性预测值通常用作性能指标。本文讨论了预测性生物标志物的这些指标,提供了使用生存或反应终点进行计算的方法,并描述了使用这些指标时所涉及的假设。