Risk stratification for cervical precancer and cancer by DH3-HPV partial genotyping and cytology in women attending cervical screening: a retrospective cohort study.

Abstract

To evaluate the effect of DH3-HPV partial genotyping for risk stratification in cervical cancer screening, we conducted a post hoc analysis within a retrospective cohort of 7263 Chinese women aged 21-71 years who participated in population-based screening. The residual cytological samples at baseline were retested with DH3-HPV and HC2 assay after 3- year follow-up. Risk values with 95% confidence intervals (95%CI) of cervical intraepithelial neoplasia grade 3/2 or worse (CIN3+/CIN2+) were estimated based on HPV and cytology results. The report complies with the STROBE statement. Across every cytological result, risk estimates obtained from DH3-HPV and HC2 were similar or almost identical. By DH3-HPV partial genotyping, risks of CIN3+/CIN2+ were invariably higher for HPV16/18 than other high-risk HPV (hrHPV). Among women with normal cytology, immediate CIN3+ risks were 8.16% (95%CI=4.19%-15.28%) for HPV16/18 positive and 0.48% (95%CI=0.13%-1.73%) for other hrHPV positive. Among women with any abnormal cytology, immediate CIN3+ risks were 33.33% (95%CI=22.24%-46.64%) for HPV16/18, and 13.33% (95%CI=8.37%-20.56%) for other hrHPV. Among 5840 women completed 3-year follow-up, the cumulative CIN3+ risk was 25.56% (95%CI=18.91%-33.59%) for HPV16/18 and 8.22% (95%CI= 6.02%-11.13%) for other hrHPV. Women with an HPV-negative result with DH3-HPV or HC2 test had very low cumulative 3-year CIN3+ risk (0.06%, 95%CI=0.02%-0.17%), which was about one tenth of women with normal cytology at baseline (0.62%, 95%CI=0.45%-0.86%). Similar patterns were observed for the endpoint of CIN2+. These findings suggest that partial genotyping of DH3-HPV performs well in risk stratification, which can better balance the benefits and harms of cervical cancer screening. This article is protected by copyright. All rights reserved.