非小细胞肺癌的生物标志物之外：临床试验设计的不断发展。
Non-Small Cell Lung Cancer beyond Biomarkers: The Evolving Landscape of Clinical Trial Design.
机构信息
Department of Medicine, Albert Einstein Medical Center, 5501 Old York Street, Philadelphia, PA 19141, USA.
Department of Thoracic Head and Neck, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Unit 432, Houston, TX 77030, USA.
出版信息
J Pers Med. 2014 Jun 30;4(3):386-401. doi: 10.3390/jpm4030386.
The approval of EGFR and ALK directed tyrosine kinase inhibitors materialized the concept of tailoring therapy on the basis of specific biomarkers for treating patients with NSCLC. Research for other biologics, although demonstrating clinical benefit, has been less successful so far for producing biomarkers that predict response. Blocking angiogenesis is the prototype for the agents that belong in the latter group that target specific molecules, yet they are currently approved for relatively unselected groups of patients. In order to meet the goal of personalizing care in the various settings of NSCLC, a wealth of biologics and compounds are currently being tested in clinical trials in different phases of clinical development. In a subset of the relevant studies, a biomarker perspective is appreciated. This review summarizes the clinical rationale of the major ongoing phase II and III NSCLC studies that employ targeting specific molecules with novel agents, as well as innovative strategies, and includes a comparative discussion of the different designs.
EGFR 和 ALK 指导的酪氨酸激酶抑制剂的批准使基于特定生物标志物为 NSCLC 患者量身定制治疗的概念成为现实。尽管其他生物制剂的研究显示出了临床益处，但到目前为止，它们在产生预测反应的生物标志物方面还不够成功。抗血管生成是属于靶向特定分子的药物的原型，然而，这些药物目前仅批准用于相对未经选择的患者群体。为了在 NSCLC 的各种治疗环境中实现个性化治疗的目标，目前正在临床试验的不同阶段对大量生物制剂和化合物进行测试。在相关研究的一部分中，人们赞赏生物标志物的视角。本综述总结了采用新型药物靶向特定分子的主要正在进行的 II 期和 III 期 NSCLC 研究的临床原理，以及创新策略，并对不同设计进行了比较讨论。
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