14-type HPV mRNA test in triage of HPV DNA-positive postmenopausal women with normal cytology

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).

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).

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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 (CIN) or cancer before they leave the screening programme.

Among postmenopausal women it has been shown that combined screening of high-risk (HR) human papillomavirus (HPV) DNA testing and cytology offers a higher sensitivity than screening with cytology alone [3, 4].

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Therefore, between 2013 and 2016 the organised cervical cancer screening programme in the Skåne region performed a double test, consisting of both HR-HPV testing and cytology in postmenopausal women aged 60-65 years. It was considered as a last control before leaving the screening program. The double test consisted of a liquid-based cytology (LBC) specimen which was co-tested for HR-HPV DNA. In HR-HPV DNA-positive women with normal cytology the LBC specimen was further investigated for the presence of HR-HPV mRNA. Among such women with normal cytology we recently reported, in a prospective, one year follow-up study, that the specificity of the HPV mRNA-based APTIMA assay (60.2%) was superior to that of the Luminex HPV DNA assay (42.3%) regarding the detection of cervical pre-cancer lesions, while the sensitivities were similar [5].

However, the aim of the present study was to prospectively evaluate if the presence of HR-HPV mRNA at enrolment could predict the future development of cervical abnormalities among HPV- DNA-positive, postmenopausal women with normal cytology over a four-year follow-up period. Another aim was to evaluate to what extent HR-HPV mRNA testing can be used as a triage method in postmenopausal women.

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