FC 21-01Suggesting ideal strategy of cervical cancer screening in Japan based on Fukui cervical cancer screening study

13. Screening methods
T. Kurokawa 1, T. Onuma 1, A. Shinagawa 1, Y. Chino 1, M. Kobayshi 2, Y. Yoshida 1.
1Department of Gynecology and Obstetrics, Faculty of Medical Sciences, University of Fukui (Japan), 2Department of Tumor Pathology, Faculty of Medical Sciences, University of Fukui (Japan)

Background / Objectives

The induction of HPV testing in cervical cancer screening has spread through world for the detection of cervical cancer precursors.1-3 But an ideal strategy unified in the world is not determined yet. Therefore, this Fukui Cervical Cancer Screening (FCCS) study has two important objectives. One is to confirm the performance of cytology testing, human papillomavirus (HPV) testing, and co-testing with cytology and HPV testing in Japan. The other is to determine whether the different approach by HPV16 type, HPV18 type, and 12 other high-risk HPV (hrHPV) types is a beneficial method for the Japanese cancer screening population.


Methods

The study enrolled 7,584 women aged ≥25 years who were undergoing routine screening. All women underwent cytology and HPV testing. Women with abnormal cytology regardless of the HPV status, those with positive hrHPV results regardless of cytology results, and those randomly selected from among women with normal cytology and negative hrHPV results were referred for colposcopy. This study had four features: a)all the samples were liquid-based cytology samples b)the cobas 4800 HPV test, which can detect HPV16, HPV18, and 12 other hrHPV types separately, was used c) bias in the cytological diagnosis was very small because the cytology was evaluated in a single institution d)a central pathology review panel determined the histological diagnosis.


Results

The prevalence of hrHPV types, HPV16 type and HPV18 type was 6.8%, 1.2%, and 0.5%, respectively. Estimated sensitivities for cervical intraepithelial neoplasia grade 2 or worse for abnormal cytology, positive hrHPV, abnormal cytology or positive hrHPV either, and abnormal cytology or positive HPV16 either were 71%, 92%, 100%, 86%, respectively. Estimated specificities for abnormal cytology, positive hrHPV, abnormal cytology or positive hrHPV either, and abnormal cytology or positive HPV16 either were 33%, 21%, 21% and 33%, respectively. Abnormal cytology or positive HPV16 type either is higher sensitivity and higher specificity than only abnormal cytology.


Conclusion

The FCCS study is first clinical trial to determine the performance of Japanese cervical cancer screening. This study demonstrated that a cervical cancer screening strategy to perform colposcopy and biopsy for women either with abnormal cytology or with HPV16 genotype might have a good balance between benefit and potential harm in Japan.


References

1. Rijkaart DC, Berkhof J, Rozendaal L, et al. Lancet Oncol 2012; 13(1): 78-88.

2. Herbert A, Best JM, Chana P, et al. J Fam Plann Reprod Health Care 2007; 33(3): 171-6.

3. Wright TC, Jr., Stoler MH, Behrens CM, et al. Am J Obstet Gynecol 2012; 206(1): 46 e1- e11.