Abstract
Background/ObjectiveHuman papillomavirus (HPV) genotyping and cytology have been recommended for colposcopy triage, but it is unclear which combinations of high-risk HPV (hrHPV) types and cytology with various thresholds provide clinically useful information for the triage after primary HPV screening on self-collected samples.MethodChinese Multi-site Screening Trial (CHIMUST) database focused on self-collected samples was reviewed using the results of Cobas4800 HPV assay. Absolute risks of each genotype for cervical intraepithelial neoplasia 2 or worse/ 3 or worse (CIN2+/CIN3+) were calculated. Triage of atypical squamous cells of undetermined significance (ASCUS) or worse cytology was used as the comparator, and diagnostic accuracy for paired comparisons between algorithms was obtained using McNemar’s test.ResultsA total of 10, 498 women were included, the overall prevalence of hrHPV, HPV16, HPV18, and Other hrHPV genotypes were 13.7%, 2.4%, 0.8%, and 10.5%, respectively. HPV16-positive women had the highest absolute risk among various genotypes for CIN2+/CIN3+ whether in normal or abnormal cytology (ASCUS or worse) and among all age groups. When compared with the comparator, combining HPV16 positivity and/or high-grade squamous intraepithelial lesion (HSIL) or worse yielded higher specificity (97.7% vs. 97.0%, p<0.0001), similar sensitivity (90.7% vs. 96.3%, p = 0.256) for detection of CIN3+, and a decrease in colposcopy referral rate from 3.5% to 2.7%, similar results were found for CIN2+. Positivity for HPV16 and/or (ASCUS or worse), and positivity for (HPV16 and/or HPV18) and/or (ASCUS or worse) achieved favorable sensitivity compared with the comparator (80.6% and 81.3% vs. 70.1% respectively for CIN2+, p<0.0001; both 96.3% vs. 96.3% for CIN3+, p = 1.000), these algorithms would reduce the colposcopy referral rate to 5.0% and 5.6% respectively, compared with 13.7% of that for HPV alone.ConclusionsTriage of HPV-positive women on self-collected samples by combining HPV16 or HPV16/18 genotyping with different thresholds of cytology could provide tradeoffs in sensitivity for detecting cervical lesions and colposcopy referral rates, and tailor management in various circumstances of clinical practice.
Highlights
Cervical cancer has caused estimated 311,365 deaths worldwide in 2018, with 90% occurring in developing countries[1]
Positivity for HPV16 and/or (ASCUS or worse), and positivity for (HPV16 and/or HPV18) and/or (ASCUS or worse) achieved favorable sensitivity compared with the comparator (80.6% and 81.3% vs. 70.1% respectively for CIN2+, p
We reviewed the Chinese Multi-site Screening Trial (CHIMUST) database, and focused on self-collected samples, to explore the performance of HPV16 alone or HPV16/18 combined with different cytological cut-offs as methods of risk-stratification to triage patients after primary HPV screening
Summary
Cervical cancer has caused estimated 311,365 deaths worldwide in 2018, with 90% occurring in developing countries[1]. Despite the effectiveness of vaccines, nearer-term impact will require delivery of cervical screening to older cohorts who will not benefit from HPV vaccination[2]. HPV test has been proved as a cost-effective primary screening method worldwide [3, 4], which could increase the coverage of screening via self-collected samples [5]. In low-resource areas without the infrastructure to support a cytology-based system, HPV testing can be done on self-collected samples, and this may offer opportunities to reach those who are reluctant to undergo gynecological examinations. Since self-collected sampling greatly reduces the physician workload for cervical cancer screening it can reduce cost and at the same time achieve better coverage in low-resource areas
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