Implementation of HPV-based cervical cancer screening in an organised regional screening programme: 3 years of experience.

OBJECTIVE: The aim of this study was to evaluate the performance of human papillomavirus (HPV)-based screening in the framework of an organised cervical cancer screening programme. METHODS: A total of 46 708 women aged 35-60 years invited to the regional cervical cancer screening programme from 1 January 2012, to 31 December 2014, were enrolled. Overall, 17 770 women were screened by the Abbot RealTime hrHPV test with cytology triage and 15 605 were screened by conventional (Papanicolaou, Pap) cytology. In both groups, women with at least low-grade squamous intraepithelial lesions were referred directly for colposcopy, whereas HPV-positive women with borderline or normal cytology were invited to intensified screening in the following year. In the Pap group, the indication for intensified follow-up was borderline cytology. RESULTS: The attendance rate was similar in the HPV and Pap groups (72% and 71%, respectively). Overall, 6.0% of women in the HPV group vs 6.4% in the Pap group were referred to intensified follow-up (relative risk 0.94, 95% confidence interval [CI]: 0.87-1.03). At the index screening years, the relative sensitivity of the HPV test with cytology triage vs conventional screening was 1.64 (95% CI: 1.05-2.55) for CIN2+ and 2.06 (95% CI: 1.17-3.41) for CIN3+. The specificity of the hrHPV test with cytology triage for CIN2+ and CIN3+ was equal to that of the Pap screening (99.2% vs 99.2% for CIN2+ and 99.1% vs 99.1% for CIN3+). CONCLUSIONS: Due to its high sensitivity and specificity, primary hrHPV testing with cytology triage seems to be acceptable for cervical cancer screening in an organised setting.

Human papillomavirus test with cytology triage in organized screening for cervical cancer.

INTRODUCTION: In randomized studies, testing for high-risk (HR) human papillomavirus (hrHPV) has been more sensitive than conventional cytology in detecting cervical intraepithelial neoplasia (CIN). The aim of this study was to evaluate the performance of HPV testing in the setting of an organized routine screening program. MATERIAL AND METHODS: Since 2012, 35- to 60-year-old women living in the city of Tampere have been screened with the Abbott RealTime hrHPV test. HPV-negative women are referred to the next screening round in five years. HPV-positive women are triaged with conventional cytology, and women with at least low-grade squamous intraepithelial lesion (LSIL+ ) are referred to colposcopy. The remaining HPV-positive women are referred for re-testing after 12 months, and then all HPV-positive women are referred to colposcopy. The data from the last cohort with cytological screening (screened in 2011) is presented for comparison. RESULTS: A total 5637 (70%) women attended the first round of HPV screening, and 369 were HPV-positive. Of them, 54 women LSIL+ were referred to colposcopy, resulting in 16 CIN2+ lesions found. Of the remaining HPV-positive women, 66% were still positive one year later, and were referred to colposcopy, with 18 additional CIN2+ lesions found. The attendance rate to the last round of cytological screening was 71% (5814 women). Sixty-four women with LSIL+ cytology were referred to colposcopy, and 11 CIN2+ lesions were found. Of the 777 women with borderline cytology and scheduled for reflex screening in the following year, 109 (19%) had ASC-US+ , and 57 underwent colposcopy, resulting in six additional CIN2+ lesions found. The total detection rate of CIN2+ was significantly higher in the HPV-screened cohort (6.0/1000 vs. 2.9/1000, p = 0.015). However, the total colposcopy rate was 4% vs. 2%, respectively (p < 0.001). CONCLUSION: Human papillomavirus testing also seems to be more sensitive than cytology in detecting CIN2+ lesions in the setting of a routine organized screening program, besides in the context of randomized trials. The problem of an increased colposcopy rate needs to be addressed in the future.