Han Qin, Guo Hongyan, Geng Li, Wang Yanjie
Department of Gynecology and Obstetrics, The Third Hospital of Peking University, Beijing 100191, China.
Chin J Cancer Res. 2020 Apr;32(2):208-217. doi: 10.21147/j.issn.1000-9604.2020.02.08.
To evaluate the efficiency of p16/Ki-67 dual stain used as a triage in cervical cancer screening.
In 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.
The 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%.
hr-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.
评估p16/Ki-67双染作为宫颈癌筛查分流检测方法的有效性。
在本研究中，我们对468例人乳头瘤病毒（HPV）16/18阳性或其他12种高危HPV（OHR-HPV）阳性的薄层液基细胞学检测（TCT）结果为意义不明确的非典型鳞状细胞（ASCUS）/低级别鳞状上皮内病变（LSIL）的女性进行了p16/Ki-67双染检测。我们评估了该分流检测的敏感性、特异性、阳性预测值（PPV）和阴性预测值（NPV）。
在HPV 16/18阳性女性中，p16/Ki-67双染的敏感性、特异性、PPV和NPV分别为91.5%/68.4%、77.0%/75.0%、73.9%/59.1%和92.8%/81.8%。在12种OHR-HPV阳性的TCT ASCUS/LSIL女性中，结果分别为79.1%/95.0%、88.5%/66.7%、88.5%/70.4%和89.2%/94.1%。p16/Ki-67双染阳性病例的癌前病变风险远高于之前，阴性病例风险较低。此外，经p16/Ki-67双染细胞学分流后，没有漏诊宫颈上皮内瘤变（CIN）III病例。在p16/Ki-67双染细胞学阳性且病理为良性或CIN I的女性中，1年进展率为20.5%，在p16/Ki-67双染细胞学阴性的女性中，1年进展率为5.6%。
高危型HPV基因分型检测在宫颈癌筛查中起重要作用。p16/Ki-67双染可能是一种有前景的分流检测方法。对于慢性宫颈炎或CIN I患者，p16/Ki-67双染细胞学阳性提示进展风险高，需要密切随访。
