一项结直肠癌筛查试验（TARGET-C）中结肠镜检查、粪便免疫化学检测及风险适应性方法的比较

Comparison of Colonoscopy, Fecal Immunochemical Test, and Risk-Adapted Approach in a Colorectal Cancer Screening Trial (TARGET-C).

作者信息

Chen Hongda, Shi Jufang, Lu Ming, Li Yanjie, Du Lingbin, Liao Xianzhen, Wei Donghua, Dong Dong, Gao Yi, Zhu Chen, Ying Rongbiao, Zheng Weifang, Yan Shipeng, Xiao Haifan, Zhang Juan, Kong Yunxin, Li Furong, Zou Shuangmei, Liu Chengcheng, Wang Hong, Zhang Yuhan, Lu Bin, Luo Chenyu, Cai Jie, Tian Jianbo, Miao Xiaoping, Ding Kefeng, Brenner Hermann, Dai Min

机构信息

Medical Research Center, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

出版信息

Clin Gastroenterol Hepatol. 2023 Mar;21(3):808-818. doi: 10.1016/j.cgh.2022.08.003. Epub 2022 Aug 11.

DOI:10.1016/j.cgh.2022.08.003

PMID:35964896

Abstract

BACKGROUND & AIMS: The screening yield and related cost of a risk-adapted screening approach compared with established screening strategies in population-based colorectal cancer (CRC) screening are not clear.

METHODS

We randomly allocated 19,373 participants into 1 of the 3 screening arms in a 1:2:2 ratio: (1) one-time colonoscopy (n = 3883); (2) annual fecal immunochemical test (FIT) (n = 7793); (3) annual risk-adapted screening (n = 7697), in which, based on the risk-stratification score, high-risk participants were referred for colonoscopy and low-risk ones were referred for FIT. Three consecutive screening rounds were conducted for both the FIT and the risk-adapted screening arms. Follow-up to trace the health outcome for all the participants was conducted over the 3-year study period. The detection rate of advanced colorectal neoplasia (CRC and advanced precancerous lesions) was the main outcome. The trial was registered in the Chinese Clinical Trial Registry (number: ChiCTR1800015506).

RESULTS

In the colonoscopy, FIT, and risk-adapted screening arms over 3 screening rounds, the participation rates were 42.4%, 99.3%, and 89.2%, respectively; the detection rates for advanced neoplasm (intention-to-treat analysis) were 2.76%, 2.17%, and 2.35%, respectively, with an odds ratio (OR) of 1.27 (95% confidence interval [CI]: 0.99-1.63; P = .056), an OR of 1.17 (95% CI, 0.91-1.49; P = .218), and an OR of 1.09 (95% CI, 0.88-1.35; P = .438); the numbers of colonoscopies needed to detect 1 advanced neoplasm were 15.4, 7.8, and 10.2, respectively; the costs for detecting 1 advanced neoplasm from a government perspective using package payment format were 6928 Chinese Yuan (CNY) ($1004), 5821 CNY ($844), and 6694 CNY ($970), respectively.

CONCLUSIONS

The risk-adapted approach is a feasible and cost-favorable strategy for population-based CRC screening and therefore could complement the well-established one-time colonoscopy and annual repeated FIT screening strategies. (Chinese Clinical Trial Registry; ChiCTR1800015506).

摘要

背景与目的

在基于人群的结直肠癌（CRC）筛查中，与既定筛查策略相比，风险适应性筛查方法的筛查收益及相关成本尚不清楚。

方法

我们将19373名参与者按1:2:2的比例随机分配至3个筛查组之一：（1）一次性结肠镜检查（n = 3883）；（2）每年粪便免疫化学检测（FIT）（n = 7793）；（3）每年风险适应性筛查（n = 7697），其中，根据风险分层评分，高危参与者接受结肠镜检查转诊，低危参与者接受FIT转诊。FIT组和风险适应性筛查组均进行连续三轮筛查。在3年研究期内对所有参与者进行随访以追踪健康结局。晚期结直肠肿瘤（CRC和晚期癌前病变）的检出率为主要结局。该试验已在中国临床试验注册中心注册（注册号：ChiCTR1800015506）。

结果

在三轮筛查中，结肠镜检查组、FIT组和风险适应性筛查组的参与率分别为42.4%、99.3%和89.2%；晚期肿瘤的检出率（意向性分析）分别为2.76%、2.17%和2.35%，优势比（OR）分别为1.27（95%置信区间[CI]：0.99 - 1.63；P = 0.056）、1.17（95% CI，0.91 - 1.49；P = 0.218）和1.09（95% CI，0.88 - 1.35；P = 0.438）；检测出1例晚期肿瘤所需的结肠镜检查次数分别为15.4、7.8和10.2；从政府角度采用包干付费形式检测出1例晚期肿瘤的成本分别为6928元人民币（CNY）（1004美元）、5821元人民币（844美元）和6694元人民币（970美元）。