FC 17-10LONG TERM SCREENING PERFORMANCE OF CYTOLOGY, HPV 16/18 GENOTYPING, AND E6 ONCOPROTEIN IN TRIAGING WOMEN WITH POSITIVE HIGH-RISK HPV TEST IN CHINA

13. Screening methods
X.L. Zhao 1, L. Dong 1, S.Y. Hu 1, Q. Zhang 1, L. Zhang 1, R. Remila 1, Q.J. Pan 2, X. Zhang 3, W.H. Zhang 4, J.F. Ma 5, Y.L. Qiao 1, F.H. Zhao 1.
1Department of Epidemiology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences& Peking Union Medical College, Beijing, 100021, China (China), 2Department of Cytopathology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, China (China), 3Department of Pathology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, China (China), 4Department of Gynecological Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100021, China (China), 5Xiangyuan Women and children’s Hospital, Changzhi, Shanxi province, 046200, China (China)

Background / Objectives

HPV genotyping and cytology test have been recommended for the triage of HPV postive women to colposcopy. E6 oncoprotein is a necessary agent of HPV driven oncogenic transformation as a potential biomarker in triaging HPV positive women. However the clinical performances of HPV genotyping, cytology and E6 oncoprotein test are almost based on cross-sectional studies and no data from prospective cohort are reported in Chinese women. This study was aimed to evaluate the long-term role of cytology, type-specific HPV and E6 oncoprotein triage based on the population-based cervical cancer screening cohort in mainland China.


Methods

We analyzed the cohort database of Shanxi Provincial of Cervical Cancer Screening Study from 2005-2014, 1734 women aged 45–55 were screened by the Hybrid Capture 2 (HC2), liquid based cytology (LBC) tests with experienced cytologist and visual inspection with acetic acid (VIA), and referred to colposcopy and biopsy if any test was positive. HPV16/18 E6 oncoprotein (E6) testing was performed on cervical samples with positive HC2 results. They were followed up in 2010 and 2014 with HPV testing, LBC and VIA (except in 2014). Based on screening results in 2005, cross-sectional and prospective clinical performance by visit, with 5-year and 10-year screening performance of CIN2+ were calculated.


Results

Among 290 HR-HPV positive women in 2005, incident sensitivity detecting CIN2+ for all triage methods decreased while incident specificity increased over time. During the 10-year follow-up, cytology with ASC-US cut-off had the highest incident sensitivity (95.2%, 92.2% and 91.5% in 2005, 2010 and 2014, respectively), HPV16/18 E6 protein testing had the highest incident specificity (92%, 94.5% and 94.7% in 2005, 2010 and 2014, respectively), and HPV16/18 genotyping were at intermediate efficiency (sensitivity were 71.4%, 68.6% and 63.3%, and specificity were 70.6%, 74.6% and 74.9% in 2005, 2010 and 2014, respectively); positive predictive value of CIN2+ in cytology with ASC-US cut-off, HPV16/18 genotyping, and HPV16/18 E6 protein testing were 96.5%, 88.5%, and 83.3% in 2014, and negative predictive value were 38.8%, 40.0%, and 58.6%, respectively.


Conclusion

Genotyping for HPV16/18 could be recommended in triaging HPV-positive women while  in situations without high quality cytologic screening. Positive HPV16/18 E6 protein testing might be a good potential biomarker for triage with its high predictive value of the long-term risk of CIN2+.


References