Circulating tumors cells as biomarkers: progress toward biomarker qualification.
Circulating tumors cells as biomarkers: progress toward biomarker qualification.
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DOI：
10.1097/ppo.0b013e31823e69ac
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发表时间：
2011-11
期刊：
影响因子：
--
通讯作者：
Scher HI
中科院分区：
文献类型：
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作者：
Danila DC;Pantel K;Fleisher M;Scher HI
个性化癌症医学需要开发肿瘤特异性生物标志物，以优化靶向治疗的选择并更好地评估治疗反应。目前对几种肿瘤类型的研究表明，检测到循环肿瘤细胞 (CTC) 的患者相对于未检测到 CTC 的患者预后较差，并且治疗后 CTC 的消除或减少与临床结果的改善相关。从常规临床实践环境中获得的静脉切开样本中检测、分离、捕获和表征 CTC 的技术进步使得能够评估不同的 CTC 生物标志物。研究 CTC 生物标志物的癌症诊断和治疗中未满足的需求包括确定预后、评估治疗效果，以及作为肿瘤来源进行生物识别和决定因素表征，以预测对一种治疗形式与另一种治疗形式的敏感性，并了解治疗抵抗机制。目前，CTC 没有单一的定义，也没有单一的 CTC“生物标志物”。相反，针对 CTC 生物标志物的多种测定（测试）正在开发中。然而，在确定任何生物标志物在医疗决策中的作用之前，必须在一系列试验中对用于测量生物标志物的测定进行分析验证，以生成支持生物标志物在给定使用环境中使用的证据。正是在这种背景下，本次综述重点关注 CTC 生物标志物检测的开发过程，目的是概述必要的步骤，以验证特定 CTC 检测在临床实践或药物开发中的医疗决策。即时检测的潜力是显而易见的。
Personalized cancer medicine requires the development of tumor-specific biomarkers to optimize selection of targeted therapies and to better assess response to therapy. Current efforts in several tumor types have shown that patients in whom circulating tumor cells (CTCs) are detected have an inferior prognosis relative to those in whom CTCs are not detected and that the elimination or decrease of CTCs following treatment is associated with improved clinical outcomes. Technological advances in the detection, isolation, capture, and characterization of CTCs from phlebotomy samples obtained in a routine clinical practice setting have enabled the evaluation of different CTC biomarkers. Unmet needs in cancer diagnosis and treatment where CTC biomarkers have been studied include determining prognosis, assessing the effects of treatment, and as a source of tumor for the biologic identification and characterization of determinants to predict sensitivity to one form of treatment versus another and to understand mechanisms of treatment resistance. At present, there is no single definition of a CTC and no single CTC “biomarker.” Rather, multiple assays (tests) are in development for CTC biomarkers. However, before the role of any biomarker in medical decision making can be determined, it is essential that the assays used to measure the biomarker are analytically validated in a sequence of trials to generate the evidence to support the biomarker’s use in the given context of use. It is against this background that this review focuses on the process of developing CTC biomarker assays, with the objective of outlining the necessary steps to qualify specific CTC tests for medical decision making in clinical practice or drug development. The potential for point-of-care tests is clear.