{"title":"常规 p16/Ki-67 免疫组化作为宫颈高级别鳞状上皮内病变诊断工具的意义和局限性。","authors":"Kazutaka Ozono, Fumi Kawakami, Yoshiki Mikami","doi":"10.5468/ogs.24236","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To evaluate the diagnostic utility and limitations of routine p16 and Ki-67 immunohistochemistry (IHC) in detecting high-grade squamous intraepithelial lesions (HSILs) in the uterine cervix.</p><p><strong>Methods: </strong>We reviewed 2,061 cervical biopsy records, including 271 morphologically indeterminate squamous lesions, evaluated using p16/Ki-67 IHC for HSIL detection or exclusion. HSIL was diagnosed based on p16 positivity and a high Ki-67 labeling index (Ki-LI). In cases that remained inconclusive after IHC, follow-up histological and/or cytological outcomes were assessed.</p><p><strong>Results: </strong>p16/Ki-67 IHC established a definitive diagnosis of either HSIL or non-HSIL in 74.2% (201/271) of morphologically indeterminate cases, whereas 25.8% (70/271) remained inconclusive. p16/Ki-67 IHC contributed to the diagnosis of HSIL in 120 cases, representing 11.9% (120/1,011) of all HSILs cases and 44.3% (120/271) of morphologically indeterminate cases. Among the 70 inconclusive cases, 58 had available follow-up data, of which 22 were subsequently diagnosed with HSIL, including 12 within 1 month of the initial biopsy. HSIL outcomes were more frequent in cases with suspicious HSIL on the initial biopsy (66.7 [12/18]). Based on the p16/Ki-LI status, patients with HSIL outcomes were categorized into three groups: p16-positive/low Ki-LI (54.2 [13/24]), p16-negative/high Ki-LI (50.0 [5/10]), and p16-negative/low Ki-LI (16.7 [4/24]). Multiple comparisons revealed a significant difference between the p16-positive/low Ki-LI and p16-negative/low Ki-LI groups (Benjamini-Yekutieli adjusted P=0.0435), whereas no significant difference was found between other groups.</p><p><strong>Conclusion: </strong>IHC using p16/Ki-67 significantly improved the diagnostic performance for HSIL. In cases that remain inconclusive after IHC, IHC-based risk stratification offers a valuable approach for surveillance, thus mitigating delays in HSIL diagnosis.</p>","PeriodicalId":37602,"journal":{"name":"Obstetrics and Gynecology Science","volume":" ","pages":""},"PeriodicalIF":2.0000,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Significance and limitations of routine p16/Ki-67 immunohistochemistry as a diagnostic tool for high-grade squamous intraepithelial lesions of the uterine cervix.\",\"authors\":\"Kazutaka Ozono, Fumi Kawakami, Yoshiki Mikami\",\"doi\":\"10.5468/ogs.24236\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To evaluate the diagnostic utility and limitations of routine p16 and Ki-67 immunohistochemistry (IHC) in detecting high-grade squamous intraepithelial lesions (HSILs) in the uterine cervix.</p><p><strong>Methods: </strong>We reviewed 2,061 cervical biopsy records, including 271 morphologically indeterminate squamous lesions, evaluated using p16/Ki-67 IHC for HSIL detection or exclusion. HSIL was diagnosed based on p16 positivity and a high Ki-67 labeling index (Ki-LI). In cases that remained inconclusive after IHC, follow-up histological and/or cytological outcomes were assessed.</p><p><strong>Results: </strong>p16/Ki-67 IHC established a definitive diagnosis of either HSIL or non-HSIL in 74.2% (201/271) of morphologically indeterminate cases, whereas 25.8% (70/271) remained inconclusive. p16/Ki-67 IHC contributed to the diagnosis of HSIL in 120 cases, representing 11.9% (120/1,011) of all HSILs cases and 44.3% (120/271) of morphologically indeterminate cases. Among the 70 inconclusive cases, 58 had available follow-up data, of which 22 were subsequently diagnosed with HSIL, including 12 within 1 month of the initial biopsy. HSIL outcomes were more frequent in cases with suspicious HSIL on the initial biopsy (66.7 [12/18]). Based on the p16/Ki-LI status, patients with HSIL outcomes were categorized into three groups: p16-positive/low Ki-LI (54.2 [13/24]), p16-negative/high Ki-LI (50.0 [5/10]), and p16-negative/low Ki-LI (16.7 [4/24]). Multiple comparisons revealed a significant difference between the p16-positive/low Ki-LI and p16-negative/low Ki-LI groups (Benjamini-Yekutieli adjusted P=0.0435), whereas no significant difference was found between other groups.</p><p><strong>Conclusion: </strong>IHC using p16/Ki-67 significantly improved the diagnostic performance for HSIL. In cases that remain inconclusive after IHC, IHC-based risk stratification offers a valuable approach for surveillance, thus mitigating delays in HSIL diagnosis.</p>\",\"PeriodicalId\":37602,\"journal\":{\"name\":\"Obstetrics and Gynecology Science\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.0000,\"publicationDate\":\"2024-12-18\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Obstetrics and Gynecology Science\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5468/ogs.24236\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Obstetrics and Gynecology Science","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5468/ogs.24236","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Significance and limitations of routine p16/Ki-67 immunohistochemistry as a diagnostic tool for high-grade squamous intraepithelial lesions of the uterine cervix.
Objective: To evaluate the diagnostic utility and limitations of routine p16 and Ki-67 immunohistochemistry (IHC) in detecting high-grade squamous intraepithelial lesions (HSILs) in the uterine cervix.
Methods: We reviewed 2,061 cervical biopsy records, including 271 morphologically indeterminate squamous lesions, evaluated using p16/Ki-67 IHC for HSIL detection or exclusion. HSIL was diagnosed based on p16 positivity and a high Ki-67 labeling index (Ki-LI). In cases that remained inconclusive after IHC, follow-up histological and/or cytological outcomes were assessed.
Results: p16/Ki-67 IHC established a definitive diagnosis of either HSIL or non-HSIL in 74.2% (201/271) of morphologically indeterminate cases, whereas 25.8% (70/271) remained inconclusive. p16/Ki-67 IHC contributed to the diagnosis of HSIL in 120 cases, representing 11.9% (120/1,011) of all HSILs cases and 44.3% (120/271) of morphologically indeterminate cases. Among the 70 inconclusive cases, 58 had available follow-up data, of which 22 were subsequently diagnosed with HSIL, including 12 within 1 month of the initial biopsy. HSIL outcomes were more frequent in cases with suspicious HSIL on the initial biopsy (66.7 [12/18]). Based on the p16/Ki-LI status, patients with HSIL outcomes were categorized into three groups: p16-positive/low Ki-LI (54.2 [13/24]), p16-negative/high Ki-LI (50.0 [5/10]), and p16-negative/low Ki-LI (16.7 [4/24]). Multiple comparisons revealed a significant difference between the p16-positive/low Ki-LI and p16-negative/low Ki-LI groups (Benjamini-Yekutieli adjusted P=0.0435), whereas no significant difference was found between other groups.
Conclusion: IHC using p16/Ki-67 significantly improved the diagnostic performance for HSIL. In cases that remain inconclusive after IHC, IHC-based risk stratification offers a valuable approach for surveillance, thus mitigating delays in HSIL diagnosis.
期刊介绍：
Obstetrics & Gynecology Science (NLM title: Obstet Gynecol Sci) is an international peer-review journal that published basic, translational, clinical research, and clinical practice guideline to promote women’s health and prevent obstetric and gynecologic disorders. The journal has an international editorial board and is published in English on the 15th day of every other month. Submitted manuscripts should not contain previously published material and should not be under consideration for publication elsewhere. The journal has been publishing articles since 1958. The aim of the journal is to publish original articles, reviews, case reports, short communications, letters to the editor, and video articles that have the potential to change the practices in women''s health care. The journal’s main focus is the diagnosis, treatment, prediction, and prevention of obstetric and gynecologic disorders. Because the life expectancy of Korean and Asian women is increasing, the journal''s editors are particularly interested in the health of elderly women in these population groups. The journal also publishes articles about reproductive biology, stem cell research, and artificial intelligence research for women; additionally, it provides insights into the physiology and mechanisms of obstetric and gynecologic diseases.
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