Article Text
Abstract
Introduction Evidence supports high-risk human papilloma virus (HPV) testing as the primary cervical cancer screening tool. However, benefits and harms should be carefully considered before replacing liquid-based cytology. In women age 50 and older, we evaluated how a commercially available DNA amplification HPV test compares with routine liquid-based cytology.
Methods This prospective study included 4043 patients who had a cervical sample analyzed from September 2011 to September 2012. Patients were followed between 64 and 76 months (median: 70 months). Samples were analyzed using both liquid-based cytology and the Cobas 4800 HPV DNA test. We calculated the diagnostic efficacy of liquid-based cytology and HPV, with or without the opposite test as triage, using cervical intraepithelial neoplasia (CIN2+/CIN3+) as reference.
Results The patients had a median age of 58 years, (range; 50–90). At baseline, HPV prevalence was 8.0%: a total of 3.7% of patients had atypical squamous cells of undetermined significance or worse (ASCUS+). Positive test results were 1.9% for liquid-based cytology with HPV triage and 3.0% for HPV with liquid-based cytology triage. The cumulative incidence of CIN3+ was 1.0% (40/4043). Sensitivities for CIN3+ were: liquid-based cytology 47.5% (31.5%–63.9%); liquid-based cytology with HPV triage 45.0% (29.3%–61.5%); HPV 90.0% (76.3%–97.2%); and HPV with liquid-based cytology triage 67.5% (50.9%–81.4%). Corresponding specificities were: liquid-based cytology 96.6% (96.0%–97.2%); liquid-based cytology with HPV triage 98.5% (98.0%–98.8%); HPV 92.8% (92.0%–93.6%); and HPV with liquid-based cytology triage 97.7% (97.2%–98.1%). At baseline, HPV testing overlooked five cases of gynecological cancer other than cervical cancer. Five cervical cancers were detected, two had been overlooked at baseline by liquid-based cytology and two by HPV testing
Conclusion HPV screening using DNA amplification is a promising alternative to liquid-based cytology in women age 50 and older, but evaluation of alternative triage methods is warranted. The risk of overlooking cancers needs consideration when replacing liquid-based cytology with HPV testing as a method for primary screening.
- cervical cancer
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Footnotes
Contributors BA contributed to the study concept and design, interpretation of data, and drafed the manuscript. SHN contributed to interpretation of data and made critical revision of the manuscript for important intellectual content. AMSJ participated in the analysis and interpretation of data, and made critical revision of the manuscript for important intellectual content. TJ contributed in the study design and with critical revision of the manuscript for important intellectual content. UJ contributed to the study concept and design with gynecological expertise, and made critical revision of the manuscript for important intellectual content. HS made the study concept and design, participated in the acquisition, analysis and interpretation of data, and made critical revision of the manuscript for important intellectual content.
Funding Diagnostic kits in this study were provided free of charge by Roche Diagnostics.
Disclaimer Roche Diagnostics had no role in the design, collection of data, statistical analyses, interpretation of results, or writing of the manuscript.
Competing interests The study received diagnostic kits free of charge from Roche Diagnostics. BA has previously received test kits from Roche and Axlab for other studies.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. According to Danish law, data can only be made available on an aggregated level after approval by the Danish authorities.