Evaluation of p16/Ki-67 dual staining in the detection of cervical precancer and cancer in China
•Co-expression of p16 and Ki-67 indicated transformation, supposed to be more specific.•p16/Ki-67 was similar to HR-HPV in sensitivity but specificity was higher.•p16/Ki-67 had a good clinical performance for triage of women with ASC-US.•p16/Ki-67 is promising for use in China’s national cervical ca...
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| Veröffentlicht in: | Cancer epidemiology 2019-04, Vol.59, p.123-128 |
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| creator | Zhang, Shao-Kai Jia, Man-Man Zhao, Dong-Mei Wu, Ze-Ni Guo, Zhen Liu, Yu-Ling Guo, Pei-Pei Chen, Qiong Cao, Xiao-Qin Liu, Shu-Zheng Chen, Wen Sun, Xi-Bin |
| description | •Co-expression of p16 and Ki-67 indicated transformation, supposed to be more specific.•p16/Ki-67 was similar to HR-HPV in sensitivity but specificity was higher.•p16/Ki-67 had a good clinical performance for triage of women with ASC-US.•p16/Ki-67 is promising for use in China’s national cervical cancer screening.
Background This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining in the detection of cervical intraepithelial neoplasia grade 2 or 3 or worse (CIN2+/CIN3+) in Chinese women.
Methods Cervical exfoliated cells were collected from 537 eligible women and were used for liquid-based cytology (LBC), p16/Ki-67 dual staining, and human papillomavirus (HPV) DNA testing. All women received colposcopy with biopsies taken at abnormal sites. Histopathological diagnoses were used as the gold standard.
Results p16/Ki-67 staining had a positivity rate of 43.58% overall; the rate increased significantly with histological severity (p 30 years. With respect to the performance of triage for women with ASC-US, sensitivities of p16/Ki-67 were 86.36% for detecting CIN2+ and 83.33% for detecting CIN3+, values similar to those of HR-HPV. However, specificities of p16/Ki-67 were both higher than those of HR-HPV (85.96% versus 67.54% for CIN2+, 79.84% versus 62.90% for CIN3+).
Conclusion P16/Ki-67 dual staining could probably provide an optional method for China’s national cervical cancer screening, and could also be considered as an efficient method of triage for managing women with ASC-US. |
| doi_str_mv | 10.1016/j.canep.2018.12.013 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2183181849</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S1877782118305265</els_id><sourcerecordid>2183181849</sourcerecordid><originalsourceid>FETCH-LOGICAL-c387t-30a5b075e578a3ec608b8e90f300b9d4ce44152e2b3838403ee1a99b86c2eba63</originalsourceid><addsrcrecordid>eNp9kUtLxDAUhYMojo7-AkECbty05jZ9pAsXMowPHHCj4C6m6a2TodPWpB3w35txHgsXrnID3zn3cg4hF8BCYJDeLEKtGuzCiIEIIQoZ8ANyAiLLgkzw98P9HMGInDq3YCxNAZJjMuIs4zlL8xPyMV2pelC9aRvaVrTzvs8mSDNaDqqmrlemMc0nNQ3t50hL7FHvWI12ZbSnOov-Ev-lqinpdvSKydw06owcVap2eL59x-Ttfvo6eQxmLw9Pk7tZoLnI-oAzlRQsSzDJhOKoUyYKgTmrOGNFXsYa4xiSCKOCCy5ixhFB5XkhUh1hoVI-Jtcb3862XwO6Xi6N01jXPqN2cDICwUGAiHOPXv1BF-1gG3-dp3KR8ITD2pBvKG1b5yxWsrNmqey3BCbXBciF_C1ArguQEElfgFddbr2HYonlXrNL3AO3GwB9GCuDVjpt0EdWGh9jL8vW_LvgBxXAlaI</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2198535316</pqid></control><display><type>article</type><title>Evaluation of p16/Ki-67 dual staining in the detection of cervical precancer and cancer in China</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Zhang, Shao-Kai ; Jia, Man-Man ; Zhao, Dong-Mei ; Wu, Ze-Ni ; Guo, Zhen ; Liu, Yu-Ling ; Guo, Pei-Pei ; Chen, Qiong ; Cao, Xiao-Qin ; Liu, Shu-Zheng ; Chen, Wen ; Sun, Xi-Bin</creator><creatorcontrib>Zhang, Shao-Kai ; Jia, Man-Man ; Zhao, Dong-Mei ; Wu, Ze-Ni ; Guo, Zhen ; Liu, Yu-Ling ; Guo, Pei-Pei ; Chen, Qiong ; Cao, Xiao-Qin ; Liu, Shu-Zheng ; Chen, Wen ; Sun, Xi-Bin</creatorcontrib><description>•Co-expression of p16 and Ki-67 indicated transformation, supposed to be more specific.•p16/Ki-67 was similar to HR-HPV in sensitivity but specificity was higher.•p16/Ki-67 had a good clinical performance for triage of women with ASC-US.•p16/Ki-67 is promising for use in China’s national cervical cancer screening.
Background This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining in the detection of cervical intraepithelial neoplasia grade 2 or 3 or worse (CIN2+/CIN3+) in Chinese women.
Methods Cervical exfoliated cells were collected from 537 eligible women and were used for liquid-based cytology (LBC), p16/Ki-67 dual staining, and human papillomavirus (HPV) DNA testing. All women received colposcopy with biopsies taken at abnormal sites. Histopathological diagnoses were used as the gold standard.
Results p16/Ki-67 staining had a positivity rate of 43.58% overall; the rate increased significantly with histological severity (p <0.001). The sensitivities of p16/ki-67 for detecting CIN2+ and CIN3+ were 88.10% and 91.30%, respectively. Compared with high-risk HPV (HR-HPV), sensitivity of p16/Ki-67 was lower for detecting CIN2+ (88.10% versus 95.71%), but similar for detecting CIN3+ (91.30% versus 96.27%). Specificities of p16/Ki-67 were 85.02% for detecting CIN2+ and 76.86% for detecting CIN3+, values similar to those for LBC (84.71% for CIN2+, 80.05% for CIN3+) but higher than those for HR-HPV (62.77% for CIN2+, 71.25% for CIN3+). All the tests performed better in women>30 years. With respect to the performance of triage for women with ASC-US, sensitivities of p16/Ki-67 were 86.36% for detecting CIN2+ and 83.33% for detecting CIN3+, values similar to those of HR-HPV. However, specificities of p16/Ki-67 were both higher than those of HR-HPV (85.96% versus 67.54% for CIN2+, 79.84% versus 62.90% for CIN3+).
Conclusion P16/Ki-67 dual staining could probably provide an optional method for China’s national cervical cancer screening, and could also be considered as an efficient method of triage for managing women with ASC-US.</description><identifier>ISSN: 1877-7821</identifier><identifier>EISSN: 1877-783X</identifier><identifier>DOI: 10.1016/j.canep.2018.12.013</identifier><identifier>PMID: 30739069</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Adult ; Aged ; Biopsy ; Cancer ; Cancer screening ; Cell cycle ; Cellular biology ; Cervical cancer ; Cervical Intraepithelial Neoplasia - diagnosis ; Cervical Intraepithelial Neoplasia - etiology ; Cervix ; China ; Clinical performance ; Colposcopy ; Consent ; Cyclin-Dependent Kinase Inhibitor p16 - analysis ; Cyclin-dependent kinases ; Cytology ; Deoxyribonucleic acid ; DNA ; DNA testing ; Early Detection of Cancer ; Epidemiology ; FDA approval ; Female ; Genetic testing ; Gynecology ; Human papillomavirus ; Humans ; Ki-67 Antigen - analysis ; Medical screening ; Middle Aged ; P16/Ki-67 dual staining ; Papillomavirus Infections - complications ; Population ; Precancer ; Pregnancy ; Sensitivity ; Sensitivity and Specificity ; Staining ; Staining and Labeling ; Uterine Cervical Neoplasms - diagnosis ; Uterine Cervical Neoplasms - etiology ; Womens health ; Young Adult</subject><ispartof>Cancer epidemiology, 2019-04, Vol.59, p.123-128</ispartof><rights>2019 Elsevier Ltd</rights><rights>Copyright © 2019 Elsevier Ltd. All rights reserved.</rights><rights>2019. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c387t-30a5b075e578a3ec608b8e90f300b9d4ce44152e2b3838403ee1a99b86c2eba63</citedby><cites>FETCH-LOGICAL-c387t-30a5b075e578a3ec608b8e90f300b9d4ce44152e2b3838403ee1a99b86c2eba63</cites><orcidid>0000-0002-3654-3109</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1877782118305265$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30739069$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhang, Shao-Kai</creatorcontrib><creatorcontrib>Jia, Man-Man</creatorcontrib><creatorcontrib>Zhao, Dong-Mei</creatorcontrib><creatorcontrib>Wu, Ze-Ni</creatorcontrib><creatorcontrib>Guo, Zhen</creatorcontrib><creatorcontrib>Liu, Yu-Ling</creatorcontrib><creatorcontrib>Guo, Pei-Pei</creatorcontrib><creatorcontrib>Chen, Qiong</creatorcontrib><creatorcontrib>Cao, Xiao-Qin</creatorcontrib><creatorcontrib>Liu, Shu-Zheng</creatorcontrib><creatorcontrib>Chen, Wen</creatorcontrib><creatorcontrib>Sun, Xi-Bin</creatorcontrib><title>Evaluation of p16/Ki-67 dual staining in the detection of cervical precancer and cancer in China</title><title>Cancer epidemiology</title><addtitle>Cancer Epidemiol</addtitle><description>•Co-expression of p16 and Ki-67 indicated transformation, supposed to be more specific.•p16/Ki-67 was similar to HR-HPV in sensitivity but specificity was higher.•p16/Ki-67 had a good clinical performance for triage of women with ASC-US.•p16/Ki-67 is promising for use in China’s national cervical cancer screening.
Background This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining in the detection of cervical intraepithelial neoplasia grade 2 or 3 or worse (CIN2+/CIN3+) in Chinese women.
Methods Cervical exfoliated cells were collected from 537 eligible women and were used for liquid-based cytology (LBC), p16/Ki-67 dual staining, and human papillomavirus (HPV) DNA testing. All women received colposcopy with biopsies taken at abnormal sites. Histopathological diagnoses were used as the gold standard.
Results p16/Ki-67 staining had a positivity rate of 43.58% overall; the rate increased significantly with histological severity (p <0.001). The sensitivities of p16/ki-67 for detecting CIN2+ and CIN3+ were 88.10% and 91.30%, respectively. Compared with high-risk HPV (HR-HPV), sensitivity of p16/Ki-67 was lower for detecting CIN2+ (88.10% versus 95.71%), but similar for detecting CIN3+ (91.30% versus 96.27%). Specificities of p16/Ki-67 were 85.02% for detecting CIN2+ and 76.86% for detecting CIN3+, values similar to those for LBC (84.71% for CIN2+, 80.05% for CIN3+) but higher than those for HR-HPV (62.77% for CIN2+, 71.25% for CIN3+). All the tests performed better in women>30 years. With respect to the performance of triage for women with ASC-US, sensitivities of p16/Ki-67 were 86.36% for detecting CIN2+ and 83.33% for detecting CIN3+, values similar to those of HR-HPV. However, specificities of p16/Ki-67 were both higher than those of HR-HPV (85.96% versus 67.54% for CIN2+, 79.84% versus 62.90% for CIN3+).
Conclusion P16/Ki-67 dual staining could probably provide an optional method for China’s national cervical cancer screening, and could also be considered as an efficient method of triage for managing women with ASC-US.</description><subject>Adult</subject><subject>Aged</subject><subject>Biopsy</subject><subject>Cancer</subject><subject>Cancer screening</subject><subject>Cell cycle</subject><subject>Cellular biology</subject><subject>Cervical cancer</subject><subject>Cervical Intraepithelial Neoplasia - diagnosis</subject><subject>Cervical Intraepithelial Neoplasia - etiology</subject><subject>Cervix</subject><subject>China</subject><subject>Clinical performance</subject><subject>Colposcopy</subject><subject>Consent</subject><subject>Cyclin-Dependent Kinase Inhibitor p16 - analysis</subject><subject>Cyclin-dependent kinases</subject><subject>Cytology</subject><subject>Deoxyribonucleic acid</subject><subject>DNA</subject><subject>DNA testing</subject><subject>Early Detection of Cancer</subject><subject>Epidemiology</subject><subject>FDA approval</subject><subject>Female</subject><subject>Genetic testing</subject><subject>Gynecology</subject><subject>Human papillomavirus</subject><subject>Humans</subject><subject>Ki-67 Antigen - analysis</subject><subject>Medical screening</subject><subject>Middle Aged</subject><subject>P16/Ki-67 dual staining</subject><subject>Papillomavirus Infections - complications</subject><subject>Population</subject><subject>Precancer</subject><subject>Pregnancy</subject><subject>Sensitivity</subject><subject>Sensitivity and Specificity</subject><subject>Staining</subject><subject>Staining and Labeling</subject><subject>Uterine Cervical Neoplasms - diagnosis</subject><subject>Uterine Cervical Neoplasms - etiology</subject><subject>Womens health</subject><subject>Young Adult</subject><issn>1877-7821</issn><issn>1877-783X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9kUtLxDAUhYMojo7-AkECbty05jZ9pAsXMowPHHCj4C6m6a2TodPWpB3w35txHgsXrnID3zn3cg4hF8BCYJDeLEKtGuzCiIEIIQoZ8ANyAiLLgkzw98P9HMGInDq3YCxNAZJjMuIs4zlL8xPyMV2pelC9aRvaVrTzvs8mSDNaDqqmrlemMc0nNQ3t50hL7FHvWI12ZbSnOov-Ev-lqinpdvSKydw06owcVap2eL59x-Ttfvo6eQxmLw9Pk7tZoLnI-oAzlRQsSzDJhOKoUyYKgTmrOGNFXsYa4xiSCKOCCy5ixhFB5XkhUh1hoVI-Jtcb3862XwO6Xi6N01jXPqN2cDICwUGAiHOPXv1BF-1gG3-dp3KR8ITD2pBvKG1b5yxWsrNmqey3BCbXBciF_C1ArguQEElfgFddbr2HYonlXrNL3AO3GwB9GCuDVjpt0EdWGh9jL8vW_LvgBxXAlaI</recordid><startdate>201904</startdate><enddate>201904</enddate><creator>Zhang, Shao-Kai</creator><creator>Jia, Man-Man</creator><creator>Zhao, Dong-Mei</creator><creator>Wu, Ze-Ni</creator><creator>Guo, Zhen</creator><creator>Liu, Yu-Ling</creator><creator>Guo, Pei-Pei</creator><creator>Chen, Qiong</creator><creator>Cao, Xiao-Qin</creator><creator>Liu, Shu-Zheng</creator><creator>Chen, Wen</creator><creator>Sun, Xi-Bin</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-3654-3109</orcidid></search><sort><creationdate>201904</creationdate><title>Evaluation of p16/Ki-67 dual staining in the detection of cervical precancer and cancer in China</title><author>Zhang, Shao-Kai ; Jia, Man-Man ; Zhao, Dong-Mei ; Wu, Ze-Ni ; Guo, Zhen ; Liu, Yu-Ling ; Guo, Pei-Pei ; Chen, Qiong ; Cao, Xiao-Qin ; Liu, Shu-Zheng ; Chen, Wen ; Sun, Xi-Bin</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c387t-30a5b075e578a3ec608b8e90f300b9d4ce44152e2b3838403ee1a99b86c2eba63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Biopsy</topic><topic>Cancer</topic><topic>Cancer screening</topic><topic>Cell cycle</topic><topic>Cellular biology</topic><topic>Cervical cancer</topic><topic>Cervical Intraepithelial Neoplasia - diagnosis</topic><topic>Cervical Intraepithelial Neoplasia - etiology</topic><topic>Cervix</topic><topic>China</topic><topic>Clinical performance</topic><topic>Colposcopy</topic><topic>Consent</topic><topic>Cyclin-Dependent Kinase Inhibitor p16 - analysis</topic><topic>Cyclin-dependent kinases</topic><topic>Cytology</topic><topic>Deoxyribonucleic acid</topic><topic>DNA</topic><topic>DNA testing</topic><topic>Early Detection of Cancer</topic><topic>Epidemiology</topic><topic>FDA approval</topic><topic>Female</topic><topic>Genetic testing</topic><topic>Gynecology</topic><topic>Human papillomavirus</topic><topic>Humans</topic><topic>Ki-67 Antigen - analysis</topic><topic>Medical screening</topic><topic>Middle Aged</topic><topic>P16/Ki-67 dual staining</topic><topic>Papillomavirus Infections - complications</topic><topic>Population</topic><topic>Precancer</topic><topic>Pregnancy</topic><topic>Sensitivity</topic><topic>Sensitivity and Specificity</topic><topic>Staining</topic><topic>Staining and Labeling</topic><topic>Uterine Cervical Neoplasms - diagnosis</topic><topic>Uterine Cervical Neoplasms - etiology</topic><topic>Womens health</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhang, Shao-Kai</creatorcontrib><creatorcontrib>Jia, Man-Man</creatorcontrib><creatorcontrib>Zhao, Dong-Mei</creatorcontrib><creatorcontrib>Wu, Ze-Ni</creatorcontrib><creatorcontrib>Guo, Zhen</creatorcontrib><creatorcontrib>Liu, Yu-Ling</creatorcontrib><creatorcontrib>Guo, Pei-Pei</creatorcontrib><creatorcontrib>Chen, Qiong</creatorcontrib><creatorcontrib>Cao, Xiao-Qin</creatorcontrib><creatorcontrib>Liu, Shu-Zheng</creatorcontrib><creatorcontrib>Chen, Wen</creatorcontrib><creatorcontrib>Sun, Xi-Bin</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Cancer epidemiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhang, Shao-Kai</au><au>Jia, Man-Man</au><au>Zhao, Dong-Mei</au><au>Wu, Ze-Ni</au><au>Guo, Zhen</au><au>Liu, Yu-Ling</au><au>Guo, Pei-Pei</au><au>Chen, Qiong</au><au>Cao, Xiao-Qin</au><au>Liu, Shu-Zheng</au><au>Chen, Wen</au><au>Sun, Xi-Bin</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of p16/Ki-67 dual staining in the detection of cervical precancer and cancer in China</atitle><jtitle>Cancer epidemiology</jtitle><addtitle>Cancer Epidemiol</addtitle><date>2019-04</date><risdate>2019</risdate><volume>59</volume><spage>123</spage><epage>128</epage><pages>123-128</pages><issn>1877-7821</issn><eissn>1877-783X</eissn><abstract>•Co-expression of p16 and Ki-67 indicated transformation, supposed to be more specific.•p16/Ki-67 was similar to HR-HPV in sensitivity but specificity was higher.•p16/Ki-67 had a good clinical performance for triage of women with ASC-US.•p16/Ki-67 is promising for use in China’s national cervical cancer screening.
Background This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining in the detection of cervical intraepithelial neoplasia grade 2 or 3 or worse (CIN2+/CIN3+) in Chinese women.
Methods Cervical exfoliated cells were collected from 537 eligible women and were used for liquid-based cytology (LBC), p16/Ki-67 dual staining, and human papillomavirus (HPV) DNA testing. All women received colposcopy with biopsies taken at abnormal sites. Histopathological diagnoses were used as the gold standard.
Results p16/Ki-67 staining had a positivity rate of 43.58% overall; the rate increased significantly with histological severity (p <0.001). The sensitivities of p16/ki-67 for detecting CIN2+ and CIN3+ were 88.10% and 91.30%, respectively. Compared with high-risk HPV (HR-HPV), sensitivity of p16/Ki-67 was lower for detecting CIN2+ (88.10% versus 95.71%), but similar for detecting CIN3+ (91.30% versus 96.27%). Specificities of p16/Ki-67 were 85.02% for detecting CIN2+ and 76.86% for detecting CIN3+, values similar to those for LBC (84.71% for CIN2+, 80.05% for CIN3+) but higher than those for HR-HPV (62.77% for CIN2+, 71.25% for CIN3+). All the tests performed better in women>30 years. With respect to the performance of triage for women with ASC-US, sensitivities of p16/Ki-67 were 86.36% for detecting CIN2+ and 83.33% for detecting CIN3+, values similar to those of HR-HPV. However, specificities of p16/Ki-67 were both higher than those of HR-HPV (85.96% versus 67.54% for CIN2+, 79.84% versus 62.90% for CIN3+).
Conclusion P16/Ki-67 dual staining could probably provide an optional method for China’s national cervical cancer screening, and could also be considered as an efficient method of triage for managing women with ASC-US.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>30739069</pmid><doi>10.1016/j.canep.2018.12.013</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0002-3654-3109</orcidid></addata></record> |
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| subjects | Adult Aged Biopsy Cancer Cancer screening Cell cycle Cellular biology Cervical cancer Cervical Intraepithelial Neoplasia - diagnosis Cervical Intraepithelial Neoplasia - etiology Cervix China Clinical performance Colposcopy Consent Cyclin-Dependent Kinase Inhibitor p16 - analysis Cyclin-dependent kinases Cytology Deoxyribonucleic acid DNA DNA testing Early Detection of Cancer Epidemiology FDA approval Female Genetic testing Gynecology Human papillomavirus Humans Ki-67 Antigen - analysis Medical screening Middle Aged P16/Ki-67 dual staining Papillomavirus Infections - complications Population Precancer Pregnancy Sensitivity Sensitivity and Specificity Staining Staining and Labeling Uterine Cervical Neoplasms - diagnosis Uterine Cervical Neoplasms - etiology Womens health Young Adult |
| title | Evaluation of p16/Ki-67 dual staining in the detection of cervical precancer and cancer in China |
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