Zhang Xi, Lian Xue-Mei, Gu Xiao-Fen, Liu Yin, Feng Chang-Yan, Li Li, Xu Hui-Fang, Du Jing-Chang, Zhao Yu-Qian, Ma Li, Liu Yun-Yong, Huang Juan-Xiu, Cao Ji, Wang Xiao-Hui, Du Ling-Bin, Duan Shuang-Xia, Wang Wen-Jun, Fan Yan-Ping, Yu Yan-Qin, Zhang Shao-Kai, Shi Ji-Hai, Qiao You-Lin
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Beijing Office for Cancer Prevention and Control, Peking University Cancer Hospital & Institute, Beijing, China.
School of Public Health and Management, Chongqing Medical University, Chongqing, China.
Ann Transl Med. 2022 Mar;10(6):324. doi: 10.21037/atm-22-988.
Biomarkers are a key tool in early detection, prognostication, survival, and predicting treatment response of colorectal cancer (CRC). However, little is known about biomarker testing for CRC patients in real-life clinical practice in China. This study aimed to address the usage of biomarker testing and analyze factors related to its acceptance among Chinese patients with advanced CRC.
A multicenter, cross-sectional, hospital-based clinical epidemiology study was conducted from March 2020 to March 2021. Nineteen hospitals were selected in seven geographical regions of China using stratified, multistage, nonrandomized cluster sampling. Data on demographics and clinical characteristics of each eligible CRC patient in stage III or IV diseases were recorded based on the patients' self-reporting and/or medical records. In addition, information on whether biomarker testing [, and microsatellite instability (MSI)] was performed, the results and timing for performing biomarker testing, and the reasons for refusing biomarker testing were also recorded. Univariate and multivariate logistic regression were conducted to explore the potential factors of biomarker testing.
A total of 4,526 patients were enrolled in the study, of whom 41.4%, 36.1%, and 28.2% underwent , and MSI testing, respectively. , and high-level MSI (MSI-high) mutation rates in Chinese patients with advanced CRC were 37.0%, 9.9%, and 8.1%, respectively. The logistic regression analysis revealed that the treating hospital, age at diagnosis, education, family income, tumor site, history of chemotherapy and radiotherapy, and metastases were dependent factors affecting the utilization of biomarker testing in advanced CRC in China (P<0.005).
The biomarker testing rate, especially MSI testing, is less prevalent in clinical practice for patients with advanced CRC in China. Our findings may guide the formulation of biomarker testing of CRC strategies in China and other low-income countries.
生物标志物是结直肠癌（CRC）早期检测、预后评估、生存分析及预测治疗反应的关键工具。然而，在中国现实临床实践中，CRC患者的生物标志物检测情况鲜为人知。本研究旨在探讨生物标志物检测的使用情况，并分析中国晚期CRC患者接受该检测的相关因素。
2020年3月至2021年3月开展了一项多中心、横断面、基于医院的临床流行病学研究。在中国七个地理区域采用分层、多阶段、非随机整群抽样法选取了19家医院。根据符合条件的III期或IV期CRC患者的自我报告和/或病历记录其人口统计学和临床特征数据。此外，还记录了是否进行生物标志物检测[、微卫星不稳定性（MSI）]、生物标志物检测的结果和时间，以及拒绝生物标志物检测的原因。采用单因素和多因素逻辑回归分析来探究生物标志物检测的潜在影响因素。
本研究共纳入4526例患者，其中分别有41.4%、36.1%和28.2%的患者接受了、和MSI检测。中国晚期CRC患者的、和高水平微卫星高度不稳定（MSI-H）突变率分别为37.0%、9.9%和8.1%。逻辑回归分析显示，治疗医院、诊断年龄、教育程度、家庭收入、肿瘤部位、放化疗史和转移情况是影响中国晚期CRC患者生物标志物检测应用的相关因素（P<0.005）。
在中国，晚期CRC患者临床实践中的生物标志物检测率，尤其是MSI检测率较低。我们的研究结果可能为中国及其他低收入国家制定CRC生物标志物检测策略提供指导。
