临床试验中治疗性癌症疫苗的生物标志物和临床结果的新概念。
New concepts of biomarkers and clinical outcomes for therapeutic cancer vaccines in clinical trials.
作者信息
Ogi Chizuru, Aruga Atsushi
机构信息
Cooperative Major in Advanced Biomedical Sciences, Joint Graduate School of Tokyo Women's Medical University & Waseda University; TWIns, 8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan.
出版信息
Immunotherapy. 2014;6(10):1025-36. doi: 10.2217/imt.14.74.
AIM
This study aimed to derive meaningful parameters for immune monitoring during cancer vaccine development by analysis of the literature.
METHODS
This retrospective study was based on analysis of clinical trials registered at ClinicalTrials.gov and published data available on PubMed.
RESULTS
The most common sample evaluated in immune monitoring was peripheral blood. All trials employed ELISA for detecting a humoral immune response; however, cellular immune assays were not used across trials. Most cellular immune assays failed to correlate with clinical outcome, although results of other methods did.
CONCLUSION
Standardization of the cellular immune assays across trials is important for predicting the effects of therapeutic cancer vaccines when considering the reliability and characteristics of the methods. Currently, assays mostly target detection of T-cell function, such as proliferation and cytokine release; however, T-cell phenotype analysis in peripheral blood and/or tumor sites may also be considered in the future.
目的
本研究旨在通过文献分析得出癌症疫苗研发过程中免疫监测的有意义参数。
方法
本回顾性研究基于对ClinicalTrials.gov注册的临床试验及PubMed上已发表数据的分析。
结果
免疫监测中评估的最常见样本是外周血。所有试验均采用酶联免疫吸附测定法检测体液免疫反应；然而，各试验未使用细胞免疫测定法。尽管其他方法的结果与临床结局相关，但大多数细胞免疫测定法与临床结局无相关性。
结论
考虑到方法的可靠性和特征，各试验间细胞免疫测定法的标准化对于预测治疗性癌症疫苗的效果很重要。目前，测定法大多针对T细胞功能的检测，如增殖和细胞因子释放；然而，未来也可考虑对外周血和/或肿瘤部位进行T细胞表型分析。
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