A shift of primary cervical screening from cytology to hrHPV detection, although only for women aged 34 to 69 years, implies a major shift in the technical infrastructure for screening. To develop real-world evidence for preferred cervical cancer screening strategies, we compared liquid based cytology (LBC) screening every 3 years (current screening modality) with high-risk human papilloma virus (hrHPV) testing every 5 years in Norway (health service study trial number 006_2014_10_RHS).
Between February 2015 and April 2017, approximately 140,00 women aged 34 to 69 years who returned for their routine, triennial cervical cancer screening were assigned hrHPV-testing (cobas® HPV Test (Roche Diagnostics) or LBC, based on even/odd day of birth. Cervical intraepithelial neoplasia grade 2, 3 and cervical cancer (CIN2+) was detected among 32,434 women who completed their follow-up of a positive screening test by early 2017.
Screening attendance by age was similar in HPV-screening and LBC-screening, being 68% after 1st and 28% after 2nd reminder. The proportion of screeningtest positives was 5.4% in LBC-screening and 6.5% in HPV-screening, and declined by increasing age. HPV16/18 was detected in 20% of hrHPV-positives. Compared to LBC-screening, we observed 40% more biopsy and/or treatment referrals, 78% more CIN2+ and 50% more CIN3+ in HPV-screening.
HPV-screening was well accepted and detected more pre-cancers, suggesting that HPV-screening should replace LBC-screening. Randomized implementation of HPV-screening allows to monitor the performance of novel technology in real-life, reassuring the overall high performance of the program and mitigating the transition.