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.
J Clin Oncol. 2024 May 10;42(14):1655-1664. doi: 10.1200/JCO.23.01284. Epub 2024 Mar 8.
To evaluate the effectiveness of endoscopic screening against incidence of and mortality from esophageal squamous cell carcinoma (ESCC).
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.
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.
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.
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。
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。
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。
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。