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内镜筛查对食管癌发病率和死亡率的影响:中国食管癌内镜筛查随机试验(ESECC)的 9 年报告。

Effectiveness of Endoscopic Screening on Esophageal Cancer Incidence and Mortality: A 9-Year Report of the Endoscopic Screening for Esophageal Cancer in China (ESECC) Randomized Trial.

机构信息

Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genetics, Peking University Cancer Hospital & Institute, Beijing, China.

Hua County People's Hospital, Hua County, China.

出版信息

J Clin Oncol. 2024 May 10;42(14):1655-1664. doi: 10.1200/JCO.23.01284. Epub 2024 Mar 8.

Abstract

PURPOSE

To evaluate the effectiveness of endoscopic screening against incidence of and mortality from esophageal squamous cell carcinoma (ESCC).

METHODS

From January 2012 to September 2016, we conducted a community-based cluster randomized controlled trial involving permanent residents age 45-69 years in a high-risk region for ESCC in northern China. A total of 668 targeted villages were randomly assigned in a 1:1 ratio to the screening group (offered Lugol's chromoendoscopy) or control group (no screening). Intention-to-treat and per-protocol analyses were performed to compare esophageal cancer (EC) incidence and mortality between the two groups. The per-protocol analysis adjusted for nonadherence to the screening procedure.

RESULTS

A total of 33,847 participants were included in the analysis: 17,104 in the screening group, 15,165 (88.7%) of whom underwent screening, and 16,743 in the control group. During a maximum follow-up of 9 years, EC incidence in the screening and control groups were 60.9 and 72.5 per 100,000 person-years, respectively; mortality in the screening and control groups were 29.7 and 32.4 per 100,000 person-years, respectively. Compared with the control group, the incidence and mortality of the screening group reduced by 19% (adjusted hazard ratio [aHR], 0.81 [95% CI, 0.60 to 1.09]) and 18% (aHR, 0.82 [95% CI, 0.53 to 1.26]), respectively, in the intention-to-treat analysis; and by 22% (aHR, 0.78 [95% CI, 0.56 to 1.10]) and 21% (aHR, 0.79 [95% CI, 0.49 to 1.30]), respectively, in the per-protocol analysis.

CONCLUSION

With a 9-year follow-up, our trial suggests that chromoendoscopic screening induces modest reductions in EC incidence and mortality. A more efficient strategy for EC screening and subsequent patient management should be established to guarantee the effectiveness of endoscopic screening.

摘要

目的

评估内镜筛查对食管鳞状细胞癌(ESCC)发病率和死亡率的影响。

方法

2012 年 1 月至 2016 年 9 月,我们在中国北方 ESCC 高危地区进行了一项基于社区的整群随机对照试验,纳入了 45-69 岁的常住居民。将 668 个目标村庄以 1:1 的比例随机分配到筛查组(提供卢戈氏染色内镜检查)或对照组(不进行筛查)。意向治疗和方案分析用于比较两组之间的食管癌(EC)发病率和死亡率。方案分析调整了对筛查程序的不依从性。

结果

共有 33847 名参与者纳入分析:筛查组 17104 名,其中 15165 名(88.7%)接受了筛查,对照组 16743 名。在最长 9 年的随访中,筛查组和对照组的 EC 发病率分别为 60.9 和 72.5/100000 人年,死亡率分别为 29.7 和 32.4/100000 人年。与对照组相比,筛查组的发病率和死亡率分别降低了 19%(调整后的危险比[aHR],0.81[95%CI,0.60 至 1.09])和 18%(aHR,0.82[95%CI,0.53 至 1.26]),意向治疗分析;以及分别降低了 22%(aHR,0.78[95%CI,0.56 至 1.10])和 21%(aHR,0.79[95%CI,0.49 至 1.30]),方案分析。

结论

随访 9 年后,本研究表明染色内镜筛查可适度降低 EC 的发病率和死亡率。应建立更有效的 EC 筛查和后续患者管理策略,以保证内镜筛查的有效性。

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