14-type HPV mRNA test in triage of HPV DNA-positive postmenopausal women with normal cytology
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RESEARCH ARTICLE
Open Access
14-type HPV mRNA test in triage of HPV DNA-positive postmenopausal women with normal cytology Katrin Christine Asciutto1*, Christer Borgfeldt1 and Ola Forslund2
Abstract Background: During 2013 and 2016 the region of Skåne, Sweden started to analyse human papillomavirus (HPV) and cytology in postmenopausal women 60–65 years of age. Our aim was to evaluate high-risk (HR) HPV mRNA testing for the triage of HPV DNA-positive postmenopausal women with normal cytology. Methods: A total of 271 women, 60–65 years of age, underwent liquid-based cytology (LBC) and HPV testing by using the HR-HPV DNA MGP-PCR-Luminex assay. HR-HPV DNA-positive women with normal cytology underwent complimentary HPV mRNA testing (Aptima, Hologic Inc.). Over a period of 49 months (SD 11.0) the women received regular follow-ups at intervals of 12–18 months. Women with abnormal cytology and/or a positive HR-HPV DNA and/or mRNA result at two subsequent visits were scheduled for colposcopy and clinical examination. Results: Over the surveillance period, 3.6% (10/271) of the HR-HPV DNA-positive women developed histologically confirmed high-grade squamous intraepithelial lesions (HSILs) or worse. The cumulative incidence rates (CIR) were 29.7% (CI 24.8–30.1) for HSIL or worse among HPV mRNA-positive women at enrolment (39.5% 107/271) and 0% among HPV mRNA-negative women (60.5%, 164/271), (p = 0.002). Conclusions: Postmenopausal women with normal cytology testing positive for HR-HPV mRNA are at increased risk for the development of high-grade cervical intraepithelial neoplasia (CIN), in contrast to women with a negative HR-HPV mRNA outcome. The HR-HPV mRNA APTIMA assay detecting 14 HR-HPV types may be a useful triage method among HPV DNA-positive postmenopausal women with normal cytology. Keywords: HR-HPV mRNA testing, Cervical cancer screening, Postmenopausal women
Background International consensus on when to stop cervical cancer screening among postmenopausal women does not exist [1]. In Sweden, 30% of cervical cancer cases are diagnosed in women older than 60 years of age (The Board of Health and Welfare (2015) Cancer incidence in Sweden 2014).
* Correspondence: [email protected] 1 Department of Obstetrics and Gynecology, Skåne University Hospital, Lund University, SE-22185 Lund, Sweden Full list of author information is available at the end of the article
In a recent audit in the region of Skåne (southern Sweden) it was observed that 24% (31/177) of squamous cervical cancer (SCC) or cervical adenocarcinoma cases between 2016 and 2017 were over 65 years of age (Personal communication Gunilla Thorn, Department of Clinical Pathology and Genetics, Lund Sweden). Most of the affected older women have symptoms at the time of diagnosis due to an advanced cancer stage, and the mortality is as high as 70% [2]. This data indicate that there is a need to identify postmenopausal women who are at risk of developing cervical intraepithelial neoplasia
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