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5-year prospective cluster randomised controlled study of a new nasopharyngeal carcinoma screening programme
Oral Plenary Abstracts
5-year prospective cluster randomised controlled study of a new nasopharyngeal carcinoma screening programme Mingfang Ji, Wei Sheng, Weimin Cheng, Jun Zhang, Su Mei Cao, Xia Yu, Songlin Huang, Shuming He, Hanwei Huang, Biaohua Wu, Kuangrong Wei, Xiaodong Liu, Shifeng Lian, Honglin Chen, Yingjie Zheng, Shoujie Huang, Shengxiang Ge, Park S P Ng, Qing Liu, Minghuang Hong, Yi Xin Zeng, Yong Yuan, Ningshao Xia, Mun-Hon Ng
Abstract Published Online October 30, 2015 Cancer Research Institute of Zhongshan City, Zhongshan, China (M Ji MD, W Cheng MD, X Yu MD, B Wu MD, K Wei MD, X Liu MD, S Lian MD, Prof Y Yuan MD); 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, China (W Sheng MSc, Prof J Zhang MSc, Shoujie Huang MSc, S Ge PhD, Prof N Xia MBBS, Prof M-H Ng PhD); Department of Epidemiology, Cancer Prevention Center, State Key Laboratory of Oncology in Southern China, Sun Yat-sen University Cancer Center, Guangzhou, China (S M Cao MD, Prof Q Liu MD, M Hong MD, Prof Y X Zeng MD); Xiaolan Public Health Service Center, Zhongshan, China (Songlin Huang MD); Xiaolan People’s Hospital of Zhongshan City, Zhongshan, China (Prof S He MD); Chen Xinhai Hospital of Xiaolan, Zhongshan, China (H Huang MD); State Key Laboratory for Emerging Infectious Diseases, Department of Microbiology, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Hong Kong Special Administrative Region, China (H Chen PhD, P S P Ng PhD); and School of Public Health, Fudan University, Shanghai, China (Prof Y Zheng MD)
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Background Nasopharyngeal carcinoma is common in China, where the incidence is as high as 2·44 per 100 000 people per year, and usually presents at advanced stage when the prognosis is poor. The human Epstein-Barr tumour virus is thought to be an important cause of this cancer. Screening programmes using the Epstein-Barr virus-specific IgA immunoglobulin antibody subtype as the principle screening test can result in early diagnosis, but the long-term effects have not been ascertained. Methods In a mass screening programme between August, 2009, and December, 2014, three townships of Zhongshan city in southern China were randomly assigned: one as the screening town and two as control towns. 16 695 residents of the screening town aged 30–59 years were enrolled, and each was randomly matched for age, sex, and date of enrolment with two residents of the control towns, resulting in 33 390 control participants in total. Participants of the screening group were tested for serum anti-Epstein-Barr virus IgA concentrations using two ELISAs. Those with moderate antibody concentrations or higher (≥0·65 probability of nasopharyngeal carcinoma units [logit P]) were invited to be retested annually in the following 3 years, and those with high antibody concentrations (≥0·98 logit P) were referred to otorhinolaryngologists for diagnostic work-up. Findings 43 nasopharyngeal carcinoma cases , with two deaths, were reported in the screening group, compared with 52 cases, with eight deaths, in the control group. The sensitivity of the screening triage was 95%, specificity was 94%, positive predictive value was 3·4%, and negative predictive value was 99·9%. Cumulative incidence was 0·26% per person for the screening group and 0·013% for those yielding a negative result, compared with 0·16% for the control group. 35 (82%) cases identified by the screening triage were localised disease, compared with 9 (19%) control cases (p<0·0001). Overall survival in the screening group is significantly greater than that in the control group (95·3% vs 78·8%; p=0·0014). Interpretation By detecting future cases, the screening programme resulted in 1·65 times more diagnosis than the control group and conferred 81% protection against nasopharyngeal carcinoma for 5 years. As a result of early diagnosis, this screening programme significantly increased overall survival. Funding This work was funded by the Eleventh National Science and Technology Support Program of China (2006BAI02A11), the Early Detection of Cancer Project in China (2010–13), and the Science and Technical Support Program of Zhongshan City (20083A183). Contributors MJ is the principle investigator and was responsible for planning the study. YZ, MH, YY, SHe, YXZ, and NX participated in study design and contributed to administrative support. M-HN, WS, and JZ analysed the data (extraction of results and statistical analysis). WC, KW, XY, SoH, HH, BW, XL, and SL participated in field management and data collection. WS did the literature search. MJ and M-HN wrote the abstract. SMC, ShH, YZ, SG, PSPN, HC, and QL revised the abstract. Declaration of interests We declare no competing interests. Correspondence to: Prof Mun-Hon Ng, 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 361005, China; Prof Yong Yuan, Cancer Research Institute of Zhongshan City, Zhongshan 528403, China [email protected] [email protected]
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5-year prospective cluster randomised controlled study of a new nasopharyngeal carcinoma screening programme Mingfang Ji, Wei Sheng, Weimin Cheng, Jun Zhang, Su Mei Cao, Xia Yu, Songlin Huang, Shuming He, Hanwei Huang, Biaohua Wu, Kuangrong Wei, Xiaodong Liu, Shifeng Lian, Honglin Chen, Yingjie Zheng, Shoujie Huang, Shengxiang Ge, Park S P Ng, Qing Liu, Minghuang Hong, Yi Xin Zeng, Yong Yuan, Ningshao Xia, Mun-Hon Ng
Abstract Published Online October 30, 2015 Cancer Research Institute of Zhongshan City, Zhongshan, China (M Ji MD, W Cheng MD, X Yu MD, B Wu MD, K Wei MD, X Liu MD, S Lian MD, Prof Y Yuan MD); 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, China (W Sheng MSc, Prof J Zhang MSc, Shoujie Huang MSc, S Ge PhD, Prof N Xia MBBS, Prof M-H Ng PhD); Department of Epidemiology, Cancer Prevention Center, State Key Laboratory of Oncology in Southern China, Sun Yat-sen University Cancer Center, Guangzhou, China (S M Cao MD, Prof Q Liu MD, M Hong MD, Prof Y X Zeng MD); Xiaolan Public Health Service Center, Zhongshan, China (Songlin Huang MD); Xiaolan People’s Hospital of Zhongshan City, Zhongshan, China (Prof S He MD); Chen Xinhai Hospital of Xiaolan, Zhongshan, China (H Huang MD); State Key Laboratory for Emerging Infectious Diseases, Department of Microbiology, Li Ka Shing Faculty of Medicine, the University of Hong Kong, Hong Kong Special Administrative Region, China (H Chen PhD, P S P Ng PhD); and School of Public Health, Fudan University, Shanghai, China (Prof Y Zheng MD)
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Background Nasopharyngeal carcinoma is common in China, where the incidence is as high as 2·44 per 100 000 people per year, and usually presents at advanced stage when the prognosis is poor. The human Epstein-Barr tumour virus is thought to be an important cause of this cancer. Screening programmes using the Epstein-Barr virus-specific IgA immunoglobulin antibody subtype as the principle screening test can result in early diagnosis, but the long-term effects have not been ascertained. Methods In a mass screening programme between August, 2009, and December, 2014, three townships of Zhongshan city in southern China were randomly assigned: one as the screening town and two as control towns. 16 695 residents of the screening town aged 30–59 years were enrolled, and each was randomly matched for age, sex, and date of enrolment with two residents of the control towns, resulting in 33 390 control participants in total. Participants of the screening group were tested for serum anti-Epstein-Barr virus IgA concentrations using two ELISAs. Those with moderate antibody concentrations or higher (≥0·65 probability of nasopharyngeal carcinoma units [logit P]) were invited to be retested annually in the following 3 years, and those with high antibody concentrations (≥0·98 logit P) were referred to otorhinolaryngologists for diagnostic work-up. Findings 43 nasopharyngeal carcinoma cases , with two deaths, were reported in the screening group, compared with 52 cases, with eight deaths, in the control group. The sensitivity of the screening triage was 95%, specificity was 94%, positive predictive value was 3·4%, and negative predictive value was 99·9%. Cumulative incidence was 0·26% per person for the screening group and 0·013% for those yielding a negative result, compared with 0·16% for the control group. 35 (82%) cases identified by the screening triage were localised disease, compared with 9 (19%) control cases (p<0·0001). Overall survival in the screening group is significantly greater than that in the control group (95·3% vs 78·8%; p=0·0014). Interpretation By detecting future cases, the screening programme resulted in 1·65 times more diagnosis than the control group and conferred 81% protection against nasopharyngeal carcinoma for 5 years. As a result of early diagnosis, this screening programme significantly increased overall survival. Funding This work was funded by the Eleventh National Science and Technology Support Program of China (2006BAI02A11), the Early Detection of Cancer Project in China (2010–13), and the Science and Technical Support Program of Zhongshan City (20083A183). Contributors MJ is the principle investigator and was responsible for planning the study. YZ, MH, YY, SHe, YXZ, and NX participated in study design and contributed to administrative support. M-HN, WS, and JZ analysed the data (extraction of results and statistical analysis). WC, KW, XY, SoH, HH, BW, XL, and SL participated in field management and data collection. WS did the literature search. MJ and M-HN wrote the abstract. SMC, ShH, YZ, SG, PSPN, HC, and QL revised the abstract. Declaration of interests We declare no competing interests. Correspondence to: Prof Mun-Hon Ng, 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 361005, China; Prof Yong Yuan, Cancer Research Institute of Zhongshan City, Zhongshan 528403, China [email protected] [email protected]
www.thelancet.com