Abstract
Within 2021, Norway intends to complete implementation of HPV DNA-based primary screening for cervical cancer for women 34–69 years, while continue cytology-based screening for women 25–33 years. Over the recent years, the incidence of cervical cancer has increased by 30% among women younger than 40 years. In this subset of women, nearly 30% were diagnosed with a normal smear, as most recent smear, prior the cancer diagnosis. This observation demands quality control of normal smears. The aim of this study was to assess increase in program sensitivity of CIN2+ after follow-up of women with false negative Pap-smears testing positive for a 3-type (-16, -18, -45) HPV mRNA test in a cohort design over one screening interval. 521 women, aged 23–39 years, and no prior history of CIN1+ or HSIL, with an ASC-US or worse smear (ASC-US+) and 1444 women with normal screening cytology comprised the study cohorts. The positivity rate for the 3-type HPV mRNA was 1.9% (28/1444). Rescreening revealed 23 women with ASC-US, two women with LSIL, two women with ASC-H, and one woman with AGUS. If the HPV mRNA-positivity rate and histology findings from samples rescreened were applied to all women with normal cytology, an estimated increase in screening sensitivity of 16.4% (95% CI:15.3–17.5) for CIN2+ and 17.3% (95% CI:16.2–18.4) for CIN3+ were achieved. By rescreening less than 2% of women with normal cytology positive for a 3-type HPV mRNA test, we achieved a significant increase in screening program sensitivity.
Highlights
Cytology screening for cervical cancer has been effective in reducing cervical cancer incidence in countries with high-coverage and high-quality screening programs [1,2,3,4]
Primary HPV-screening with DNA-based tests find high-grade cervical intraepithelial neoplasia grade 2 and 3 (CIN2+) at an earlier time point than cytology based screening do [7]
Norwegian regulations exempt quality assurance studies from written informed consent from the patients. In this low risk population of women younger than 40 years index smear were normal in 88.1% (3845/4366) of the women, 8.5% (370/4366) had ASC-US, 1.9% (82/4366) had low-grade squamous intraepithelial lesion (LSIL) (ASC-US/LSIL-arm), and 1.6% (69/3466) had high-grade squamous intraepithelial lesions (HSIL), ASC-H, AGUS or ACIS (HSIL-arm)
Summary
Cytology screening for cervical cancer has been effective in reducing cervical cancer incidence in countries with high-coverage and high-quality screening programs [1,2,3,4]. Primary HPV-screening with DNA-based tests find high-grade cervical intraepithelial neoplasia grade 2 and 3 (CIN2+) at an earlier time point than cytology based screening do [7]. A meta-analysis of randomized screening trials against cervical cancer reported more invasive cervical cancer cases detected in the cytology-arm compared with the HPV-arm [9]. In women younger than 30 years primary HPV DNA based screening is very ineffective and not costeffective due to the high prevalence of transient HPV-infections [10,11,12]
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