M F Ji1, W Sheng2, W M Cheng1, M H Ng2, B H Wu1, X Yu1, K R Wei1, F G Li1, S F Lian1, P P Wang1, W Quan1, L Deng1, X H Li1, X D Liu1, Y L Xie1, S J Huang2, S X Ge2, S L Huang3, X J Liang3, S M He4, H W Huang5, S L Xia6, P S Ng7, H L Chen7, S H Xie8, Q Liu8, M H Hong8, J Ma8, Y Yuan1, N S Xia2, J Zhang9, S M Cao10. 1. Cancer Research Institute of Zhongshan City, Zhongshan Hospital of Sun Yat-sen University, Zhongshan, People's Republic of China. 2. State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biological Products, School of Public Health, Xiamen University, Xiamen, People's Republic of China. 3. Xiaolan Public Health Service Center, Zhongshan, People's Republic of China. 4. Xiaolan People's Hospital of Zhongshan City, Zhongshan, People's Republic of China. 5. Chen Xinhai Hospital of Xiaolan, Zhongshan, People's Republic of China. 6. Zhongshan Center for Disease Control and Prevention, Zhongshan, People's Republic of China. 7. State Key Laboratory for Emerging Infectious Diseases, Department of Microbiology and Research Centre of Infection and Immunology, The University of Hong Kong, Hong Kong, SAR. 8. State Key Laboratory of Oncology in Southern China, Department of Epidemiology, Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. 9. State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biological Products, School of Public Health, Xiamen University, Xiamen, People's Republic of China. Electronic address: zhangj@xmu.edu.cn. 10. State Key Laboratory of Oncology in Southern China, Department of Epidemiology, Cancer Prevention Center, Sun Yat-sen University Cancer Center, Guangzhou, People's Republic of China. Electronic address: caosm@sysucc.org.cn.
Abstract
BACKGROUND: Previous mass screening studies have shown that IgA antibodies against Epstein-Barr Virus (EBV) can facilitate early detection of nasopharyngeal carcinoma (NPC), but the impact of EBV-antibody screening for NPC-specific mortality remains unknown. PATIENTS AND METHODS: A prospective, cluster randomized, controlled trial for NPC screening (PRO-NPC-001) was conducted in 3 selected towns of Zhongshan City and 13 selected towns of Sihui City in southern China beginning in 2008. Serum samples of the screening group were tested for two previously selected anti-EBV antibodies. Subjects with serological medium risk were subsequently retested annually for 3 years, and those with serological high risk were referred to otorhinolaryngologists for diagnostic check-up. An interim analysis was carried out to evaluate the primary end points of the NPC-specific mortality and the early diagnostic rate, and the secondary end point of the NPC incidence, through linkage with the database of Zhongshan City. RESULTS:Among 70 296 total subjects, 29 413 screened participants (41.8% of the total subjects) in the screening group and 50 636 in the control group, 153 (43.3 per 100 000 person-year), 62 (55.3 per 100 000 person-year) and 99 (33.1 per 100 000 person-year) NPC cases were identified. The early diagnostic rates of NPC were significantly higher in the participants (79.0%, P < 0.0001) and the screening group (45.9%, P < 0.0001) compared with the control group (20.6%). Although no differences were found between NPC-specific mortality of the screening group and the control group [relative risk (RR)= 0.82, 95% confidence interval (CI) 0.37-1.79], lower NPC-specific mortality was noticed among participants from the screening group versus the control group (RR = 0.22, 95% CI 0.09-0.49). CONCLUSION: IgA antibodies against EBV can identify high-risk population and was effective in screening for early asymptomatic NPC. Although the mortality reduction was not significant in the primary end point, we noted encouraging evidence of a mortality reduction in screening participants in this interim analysis. CLINICAL TRIAL NUMBER: NCT00941538.
RCT Entities:
BACKGROUND: Previous mass screening studies have shown that IgA antibodies against Epstein-Barr Virus (EBV) can facilitate early detection of nasopharyngeal carcinoma (NPC), but the impact of EBV-antibody screening for NPC-specific mortality remains unknown. PATIENTS AND METHODS: A prospective, cluster randomized, controlled trial for NPC screening (PRO-NPC-001) was conducted in 3 selected towns of Zhongshan City and 13 selected towns of Sihui City in southern China beginning in 2008. Serum samples of the screening group were tested for two previously selected anti-EBV antibodies. Subjects with serological medium risk were subsequently retested annually for 3 years, and those with serological high risk were referred to otorhinolaryngologists for diagnostic check-up. An interim analysis was carried out to evaluate the primary end points of the NPC-specific mortality and the early diagnostic rate, and the secondary end point of the NPC incidence, through linkage with the database of Zhongshan City. RESULTS: Among 70 296 total subjects, 29 413 screened participants (41.8% of the total subjects) in the screening group and 50 636 in the control group, 153 (43.3 per 100 000 person-year), 62 (55.3 per 100 000 person-year) and 99 (33.1 per 100 000 person-year) NPC cases were identified. The early diagnostic rates of NPC were significantly higher in the participants (79.0%, P < 0.0001) and the screening group (45.9%, P < 0.0001) compared with the control group (20.6%). Although no differences were found between NPC-specific mortality of the screening group and the control group [relative risk (RR)= 0.82, 95% confidence interval (CI) 0.37-1.79], lower NPC-specific mortality was noticed among participants from the screening group versus the control group (RR = 0.22, 95% CI 0.09-0.49). CONCLUSION: IgA antibodies against EBV can identify high-risk population and was effective in screening for early asymptomatic NPC. Although the mortality reduction was not significant in the primary end point, we noted encouraging evidence of a mortality reduction in screening participants in this interim analysis. CLINICAL TRIAL NUMBER: NCT00941538.
Authors: Kenneth C W Wong; Edwin P Hui; Kwok-Wai Lo; Wai Kei Jacky Lam; David Johnson; Lili Li; Qian Tao; Kwan Chee Allen Chan; Ka-Fai To; Ann D King; Brigette B Y Ma; Anthony T C Chan Journal: Nat Rev Clin Oncol Date: 2021-06-30 Impact factor: 66.675