Genitourinary Oncology Service, Department of Medicine, Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
Cancer J. 2011 Nov-Dec;17(6):438-50. doi: 10.1097/PPO.0b013e31823e69ac.
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.
个体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。目前在几种肿瘤类型中的努力表明，与未检测到循环肿瘤细胞（CTC）的患者相比，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局的改善相关。在常规临床实践环境中从采血样本中检测、分离、捕获和表征 CTC 的技术进步使评估不同的 CTC 生物标志物成为可能。在癌症诊断和治疗中，尚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，用于生物鉴定和特征分析，以预测对一种治疗方法与另一种治疗方法的敏感性，并了解治疗耐药性的机制。目前，尚无 CTC 的单一定义，也没有单一的 CTC“生物标志物”。相反，正在开发多种用于 CTC 生物标志物的检测方法。但是，在确定任何生物标志物在医学决策中的作用之前，必须在一系列试验中对用于测量生物标志物的检测方法进行分析验证，以生成支持在给定应用背景下使用生物标志物的证据。正是在这种背景下，本文重点介绍了开发 CTC 生物标志物检测方法的过程，旨在概述将特定 CTC 检测用于临床实践或药物开发中的医学决策的必要步骤。即时检测的潜力是显而易见的。
