Abstract
ObjectiveTo evaluate the efficiency of p16/Ki-67 dual stain used as a triage in cervical cancer screening.MethodsIn this study, we did 468 p16/Ki-67 dual stain in human papillomavirus (HPV) 16/18-positive or 12 other high-risk HPV (OHR-HPV) positive Thinprep cytologic test (TCT) atypical squamous cells of undetermined significance (ASCUS)/ lower-grade squamous intraepithelial lesion (LSIL) women. We evaluated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the triage test.ResultsThe sensitivity, specificity, PPV and NPV of p16/Ki-67 dual stain in HPV 16/18-positive women were 91.5%/68.4%, 77.0%/75.0%, 73.9%/59.1% and 92.8%/81.8%. In 12 OHR-HPV positive TCT ASCUS/LSIL women, the results were 79.1%/95.0%, 88.5%/66.7%, 88.5%/70.4% and 89.2%/94.1%. The risk of precancerous lesions in p16/Ki-67 dual stain positive cases was much higher than before, and the negative cases had lower risk. Besides, there was no cervical intraepithelial neoplasia (CIN) III case missed after triaged by p16/Ki-67 dual-stained cytology. In p16/Ki-67 dual-stained cytology positive women with benign pathology or CIN I, the 1-year progression rate is 20.5% and in p16/Ki-67 dual-stained cytology negative women, the 1-year progression rate is 5.6%.Conclusionshr-HPV genotyping test plays an important role in cervical cancer screening. p16/Ki-67 dual stain may be a promising triage test. As for chronic cervicitis or CIN I patients, a positive p16/Ki-67 dual-stained cytology suggests a high risk in progression and need to be followed up closely.
Highlights
Cervical cancer poses a serious threat to women’s health
We evaluated the performance of p16/Ki-67 dual-stained cytology for cervical cancer screening triage in human papillomavirus (HPV) 16/18-positive or OHR HPV-positive patients with atypical squamous cells of undetermined significance (ASCUS)/lower-grade squamous intraepithelial lesion (LSIL) Thinprep cytologic test (TCT) results
As we aimed to evaluate the performance of p16/Ki-67 dual-stained cytology for triage in HPV16/18-positive or OHR HPV-positive women with TCT results of ASCUS/LSIL, we excluded patients with multiple infections
Summary
Many clinical studies have confirmed that persistent infection with high-risk human papillomavirus (hr-HPV) is a cause of cervical cancer and cervical intraepithelial neoplasia (CIN). With the high sensitivity and negative predictive value (NPV) of HPV testing, HPV-negative women are at a very low risk for developing cervical cancer over multiple years. The HPV genotype seems to be the most important factor in identifying persistent infections and disease progression. HPV 16 has the highest carcinogenic ability and may lead to 55%−60% of cervical cancer cases [1]. HPV 18 is the second most common genotype and is associated with 10%−15% of cervical cancer cases [1]. The remaining cases of cervical cancer are related to approximately 12 genotypes of HPV [3]. Understanding the relationship between HPV and cervical cancer has led to the development of new www.cjcrcn.org
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