基于爱泼斯坦-巴尔病毒血清学的筛查计划对鼻咽癌死亡率的影响：一项整群随机对照试验。

Impact of an Epstein-Barr Virus Serology-Based Screening Program on Nasopharyngeal Carcinoma Mortality: A Cluster-Randomized Controlled Trial.

作者信息

Chen Wen-Jie, Yu Xia, Lu Yu-Qiang, Pfeiffer Ruth M, Ling Wei, Xie Shang-Hang, Wu Zhi-Cong, Li Xue-Qi, Fan Yu-Ying, Wu Biao-Hua, Wei Kuang-Rong, Rao Hui-Lan, Huang Qi-Hong, Guo Xiang, Sun Ying, Ma Jun, Liu Qing, Hildesheim Allan, Hong Ming-Huang, Zeng Yi-Xin, Ji Ming-Fang, Liu Zhiwei, Cao Su-Mei

机构信息

Department of Cancer Prevention, Sun Yat-sen University Cancer Center, Guangzhou, China.

State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, and Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Sun Yat-sen University Cancer Center, Guangzhou, China.

出版信息

J Clin Oncol. 2025 Jan;43(1):22-31. doi: 10.1200/JCO.23.01296. Epub 2024 Oct 1.

DOI:10.1200/JCO.23.01296

PMID:39353160

Abstract

PURPOSE

Screening for nasopharyngeal carcinoma (NPC) has shown an improvement in early detection and survival rates of NPC in endemic regions. It is critical to evaluate whether NPC screening can reduce NPC-specific mortality in the population.

METHODS

Sixteen towns in Sihui and Zhongshan cities, China, were selected; eight were randomly allocated to the screening group and eight to the control group. Residents age 30-69 years with no history of NPC were included from January 1, 2008, to December 31, 2015. Residents in the screening towns were invited to undergo serum Epstein-Barr virus (EBV) viral capsid antigen/nuclear antigen 1-immunoglobulin A antibody tests; others received no intervention. The population was followed until December 31, 2019. Nonparametric tests and Poisson regression models were used to estimate the screening effect on NPC mortality, accounting for the cluster-randomized design. The trial is registered with ClinicalTrials.gov (identifier: NCT00941538).

RESULTS

A total of 174,943 residents in the screening group and 186,263 residents in the control group were included. NPC incidence and overall mortality were similar between the two groups. A total of 52,498 (30.0% of 174,943) residents participated in the serum EBV antibody test. The overall compliance rate for endoscopic examination and/or biopsies among baseline and ever-classified high-risk participants was 65.9% (1,110 of 1,685) and 67.6% (1,703 of 2,518), respectively. A significant 30% reduction in NPC mortality was observed in the screening group compared with the control group (standardized NPC-specific mortality rate of 8.2 NPC deaths per 1,000 person-years versus 12.5; adjusted rate ratio [RR], 0.70 [95% CI, 0.49 to 0.997]; = .048). This benefit was most evident among individuals age 50 years and older (RR, 0.56 [95% CI, 0.37 to 0.85]; = .007) compared with those younger than 50 years (RR, 0.96 [95% CI, 0.64 to 1.46]; = .856).

CONCLUSION

In this 12-year trial, EBV antibody testing resulted in a significant reduction in NPC mortality.

摘要

目的

鼻咽癌（NPC）筛查已显示在流行地区提高了NPC的早期检测率和生存率。评估NPC筛查能否降低人群中NPC特异性死亡率至关重要。

方法

在中国四会市和中山市选择了16个镇；8个被随机分配到筛查组，8个被分配到对照组。纳入2008年1月1日至2015年12月31日期间年龄在30 - 69岁且无NPC病史的居民。邀请筛查镇的居民接受血清爱泼斯坦 - 巴尔病毒（EBV）病毒衣壳抗原/核抗原1 - 免疫球蛋白A抗体检测；其他居民未接受干预。对该人群进行随访直至2019年12月31日。使用非参数检验和泊松回归模型来估计筛查对NPC死亡率的影响，并考虑集群随机设计。该试验已在ClinicalTrials.gov注册（标识符：NCT00941538）。

结果

筛查组共纳入174,943名居民，对照组共纳入186,263名居民。两组的NPC发病率和总死亡率相似。共有52,498名（占174,943名的30.0%）居民参加了血清EBV抗体检测。基线和曾被分类为高危参与者中内镜检查和/或活检的总体依从率分别为65.9%（1,685名中的1,110名）和67.6%（2,518名中的1,703名）。与对照组相比，筛查组的NPC死亡率显著降低了30%（标准化NPC特异性死亡率为每1,000人年8.2例NPC死亡，而对照组为12.5例；调整后的率比[RR]为0.70[95%CI，0.49至0.997]；P = 0.048）。与年龄小于50岁的人群（RR，0.96[95%CI，0.64至1.46]；P = 0.856）相比，这种益处在50岁及以上的个体中最为明显（RR，0.56[95%CI，0.37至0.85]；P = 0.007）。