Implementing Liquid Biopsies in Clinical Trials: State of Affairs, Opportunities, and Challenges.
Implementing Liquid Biopsies in Clinical Trials: State of Affairs, Opportunities, and Challenges.
复制标题
DOI：
10.1097/ppo.0000000000000309
复制
发表时间：
2018
期刊：
影响因子：
--
通讯作者：
Chalmers JJ
中科院分区：
文献类型：
--
作者：
Lustberg MB;Stover DG;Chalmers JJ
个性化医疗的主要目标是开发肿瘤特异性生物标志物，以帮助治疗选择并更好地评估对靶向治疗的反应。循环血液标志物作为疾病状态的替代真实的时间活检（称为“液体活检”）的评估一直在研究中。有许多不同类型的液体活检，每种都具有不同的功能和局限性。这些包括肿瘤标志物、循环肿瘤细胞（CTC）、无细胞DNA和细胞外囊泡（包括外来体）。多项临床试验评估了液体活检作为预后生物标志物的积极结果。正在进行其他研究，以评价液体活检作为预测生物标志物、药效学生物标志物和治疗反应评价的替代疗效终点。在将液体活检实施到临床试验和随后的常规临床实践中存在一些挑战和障碍，本文将对此进行综述。
A primary goal of personalized medicine is to develop tumor specific biomarkers to aid in treatment selection and to better evaluate response to targeted therapies. The assessment of circulating blood markers as surrogate real time biopsies of disease status, termed ‘liquid biopsies,’ has been under investigation. There are many different types of liquid biopsies each with different functionalities and limitations. These include tumor markers, circulating tumor cells (CTCs), cell-free DNA, and extracellular vesicles including exosomes. Multiple clinical trials have evaluated liquid biopsies is as prognostic biomarkers with positive results. Additional studies are underway to evaluate liquid biopsies as predictive biomarkers, pharmacodynamic biomarkers and surrogate efficacy endpoints for treatment response evaluation. There are several challenges and barriers in implementation of liquid biopsies into clinical trials and subsequently into routine clinical practice which will be addressed in this review.