Identification of ideal strategy of cervical cancer screening in Japan based on Fukui cervical cancer screening study.

Abstract

e17025 Background:The estimated age-standardized incidence rate for cervical cancer is higher in Japan than in North America and the UK. It is important to improve cancer screening. The introduction of HPV testing with cytology for triage of those that test positive for cervical cancer screening has been challenging. The Fukui Cervical Cancer Screening (FCCS) study was designed to determine the best cervical cancer screening method in the Japanese population. We performed a subanalysis using baseline data of FCCS study to determine the performance of cytology, the human papillomavirus (HPV) testing and cotesting with cytology and HPV testing, and to evaluate whether the stratification of HPV16, HPV18, and 12 other hrHPV types appropriately balances risks and harms in the Japanese cancer screening population. Methods:The study enrolled 7,584 women aged 25 years or older undergoing routine screening. All women underwent liquid-based cytology (LBC) and cobas HPV testing. Women with abnormal cytology regardless of the HPV status, women with positive hrHPV results regardless of cytology results, and women randomly selected from among those with normal cytology and negative hrHPV results were referred for colposcopy. Results:The prevalence of hrHPV, HPV16, and HPV18 was 6.8%, 1.2%, and 0.5%, respectively. The estimated sensitivities for cervical intraepithelial neoplasia (CIN) 2 or worse for cytology, HPV testing, and cotesting with cytology and HPV testing were 71%, 92%, and 100%, respectively. The estimated positive predictive values for cytology, HPV testing, and cotesting with cytology and HPV testing were 33%, 21% and 21%, respectively. Using a strategy whereby those with abnormal cytology or positive HPV16 genotype undergo colposcopy and biopsy results in a sensitivity of 85% and a positive predictive value of 33%. This strategy results in improved sensitivity while at the same time maintains the positive predictive value compared to screening with cytology alone. Conclusions:Baseline data from the FCCS study suggests that strategy of using colposcopy for women with abnormal cytology and/or HPV16 positivity appropriately balances risks and harms for Japanese women. Clinical trial information: UMIN000025977.