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Data sources: [7], The loss of expression of p16 has been observed in oral premalignant lesions and primary tumors of the oral cavity. The same was true for the ISPs diagnosis of CIN3 (data not shown). See this image and copyright information in PMC. Wolters Kluwer Health, Inc. and/or its subsidiaries. Variability of pathologists' utilization of p16 and ki-67 immunostaining in the diagnosis of cervical biopsies in routine pathology practice and its impact on the frequencies of cervical intraepithelial neoplasia diagnoses and cytohistologic correlations. Assessment of immunohistochemical expression of p16 in head and neck Federal government websites often end in .gov or .mil. 21. 3. The average difference in NPA of ISPs in round 2 (H&E+p16) versus round 1 (H&E only) also differs by diagnostic approach, but moves in the opposite direction to PPA. Objectives. To review the practical use of p16 immunohistochemistry for evaluating melanocytic lesions, particularly for differentiating benign from malignant tumors, and to perform a meta-analysis of primary studies evaluating p16 immunohistochemistry in melanocytic lesions. -, Head and neck squamous cell carcinoma-comparative evaluation of pathological parameters in young and old patients. It should be noted that both in this study and in the ATHENA trial where p16 IHC was sometimes used on cases not fulfilling the LAST criteria, some biopsies were identified in which detached fragments CIN2+ were overlooked when the H&E slide was read by the CPR. Bethesda, MD 20894, Web Policies Clinical Interpretation of Immunohistochemistry in Gynaecological All H&E . Agreement for rating p16 INK4a immunohistochemistry into p16 INK4a positive or negative was very high (pooled group , 0.99; 95% CI, 0.88-0.92) but included cases of p16 INK4a-positive CIN1 not considered precancer. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. Am J Surg Pathol. History of abnormal sexual habit was present in 24 patients, of which 19 (79.17%) were having positive p16 expression. The Lower Anogenital Squamous Terminology (LAST) Project recommends the use of p16 immunohistochemistry as an adjunct to morphologic assessment of cervical biopsies according to a specific set of criteria. 2021 Feb 4;7:568946. doi: 10.3389/fmed.2020.568946. eCollection 2020. MeSH and transmitted securely. However, no real difference in OPA (equivalent to accuracy) was found with the use of p16 IHC in non-LAST cases, and there was a small reduction in NPA (equivalent to specificity). We analyzed the effect of adjunctive p16 according to LAST criteria in a US-based diagnostic utility study involving 70 surgical pathologists providing a total of 38,500 reads on cervical biopsies. Routine use of adjunctive. These finding suggest a low prevalence of HPV as a cause of HNSCC in our population. The site is secure. Formalin fixation leads to robust, easily interpretable p16 staining in cell blocks. Evaluation of controls, interpretation and reporting of results, and experience of the pathologist are factors accounting for postanalytical variables [44].Because of interobserver variability in reporting p16 IHC, investigators are looking to pursue methods for automated analysis [48].For such an application, the antibody must be easy to use and reproducible with protocols that are . Smilek P, Dusek L, Vesely K, Rottenberg J, Kostrica R. Correlation of expression of Ki67, EFGR, C-erbB2, MMP-9, p53, bcl2, CD34 and cell cycle analysis with survival in head and neck squamous cell cancer. Given the large variation in the frequency that p16 IHC was requested by the ISPs, as well as the wide variations in PPA and NPA for CIN2+ compared with the CPR, we felt it would be useful to perform a stratified analysis separating the ISPs into groups that appear to take different approaches to diagnosing cervical biopsies. [3] Squamous cell carcinoma of the upper aerodigestive tract typically occurs in older patients in their fifth to seventh decades of life and older. Search for Similar Articles Dupont WD, Plummer D, Lewis JS (September 2017). BJOG. [1] In India, it ranks among the top three types of cancer. Association of p16 overexpression with various clinicopathologic parameters including T-stage, N-stage, grade, recurrence status, and risk factors was evaluated. Am J Surg Pathol. Immunostaining for p16INK4a used as a conjunctive tool improves interobserver agreement of the histologic diagnosis of cervical intraepithelial neoplasia. and Dragomir et al. Improvements in agreement rates were higher by 60% when CPRH&E+p16 was as reference diagnosis versus CPRH&E: adding p16 per LAST to ISPs slide interpretation resulted in an increase in OPA of 4.4% (95% CI, 3.7-5.0; P<0.0001), PPA of 8.1% (95% CI, 6.5-9.7; P<0.0001), and NPA of 3.5% (95% CI, 2.8-4.2; P<0.0001). Obstetric outcomes after conservative treatment for intraepithelial or early invasive cervical lesions: systematic review and meta-analysis. Similar to our study, Ralli et al. It provides important additional information to clinical and pathologic staging. Wright, Thomas C. Jr MD*; Stoler, Mark H. MD; Ferenczy, Alex MD; Ranger-Moore, James PhD; Fang, Qijun PhD; Kapadia, Monesh MD; Singh, Shalini MD; Ridder, Ruediger PhD, *Department of Pathology, Columbia University, New York City, NY, Department of Pathology, University of Virginia Health System, Charlottesville, VA, Department of Pathology, McGill University Health Center, Montreal, QC, Canada, Ventana Medical Systems Inc/Roche Tissue Diagnostics, Tucson, AZ. [4], According to the current literature, the risk factors of HNSCC are surprisingly similar to those of cervical cancer and cervical intraepithelial neoplasia, including the number of sexual partners, younger age at first sexual intercourse, practice of oral sex, history of genital warts and younger age. p16 is a commonly used immunostain. Head-and-neck squamous cell carcinoma, human papillomavirus, immunohistochemistry, p16. Bethesda, MD 20894, Web Policies PMC Therefore, it remains unclear exactly which cervical biopsies would most benefit from p16 IHC and whether pathologists can actually reproducibly identify which biopsies should be stained using the LAST criteria. [12,17] They hypothesized that tumors exhibiting p16 expression effect cell differentiation. Given the intrinsic subjectivity of the morphologic assessment of cervical biopsies, the variability between different pathologists in the frequency at which they request p16 IHC is not surprising. p16 immunostaining in histological grading of anal squamous - Nature Hashmi AA, Iftikhar SN, Haider R, Baig NN, Asif MG, Irfan M. Cureus. Ralli M, Singh S, Yadav SP, Sharma N, Verma R, Sen R. Assessment and clinicopathological correlation of p16 expression in head and neck squamous cell carcinoma. Efficiency of immunohistochemical p16 expression and HPV typing in cervical squamous intraepithelial lesion grading and review of the p16 literature. For example, with the tertile of ISPs favoring specificity over sensitivity, the average difference in PPA (ie, sensitivity for CIN2+) with the use of p16 IHC was 21% in both LAST and non-LAST cases. The .gov means its official. Human papillomavirus, p16 and p53 expression associated with survival of head and neck cancer. Table 2 illustrates the correlation of p16 expression with various risk factors. A number of studies have documented improved sensitivity for detecting CIN2,3 and improved reproducibility among pathologists when p16INK4a immunostaining is utilized in conjunction with H&E-stained slides to diagnose cervical biopsies.811 In an effort to reconcile the multiple and confusing terminologies used for diagnosing cervical biopsies, in 2010 the College of American Pathologists (CAP) and American Society for Colposcopy and Cervical Pathology (ASCCP) organized a terminology standardization project referred to as the Lower Anogenital Squamous Terminology (LAST) Standardization Project. Moreover, p16 over expression correlates with good prognosis in head and neck squamous cell carcinoma (HNSCC). Kalpien-Meier for epidermal growth factor receptor (EGFR) overexpression (disease-free survival), MeSH Although most p16 results are distinctly positive or negative, certain ones are ambiguous: they meet some but not all requirements for the All 70 ISPs who participated in this study were (i) board-certified in anatomic pathology, (ii) licensed and currently practicing medicine in the United States, and (iii) evaluate cervical histology specimens as part of their routine clinical practice. Comparison of SOX-10, HMB-45, and Melan-A in Benign Melanocytic Lesions. p53 expression but not p16(INK4A) correlates with human papillomavirus-associated esophageal squamous cell carcinoma in Kazakh population. The LAST and 2014 WHO terminology that incorporates Bethesda terminology was simplified to the CIN grade: CIN1 indicates LSIL, CIN2 indicates high-grade squamous intraepithelial lesions (HSIL) (CIN2), and CIN3 indicates HSIL (CIN3). Yildiz IZ, Usubtn A, Firat P, Ayhan A, Kkali T. Pathol Res Pract. Rischin D, Young RJ, Fisher R, Fox SB, Le QT, Peters LJ, et al. Ai L, Stephenson KK, Ling W, Zuo C, Mukunyadzi P, Suen JY, et al. 8600 Rockville Pike Prevalence of Human Papillomavirus (HPV) Infection and the Association with Survival in Saudi Patients with Head and Neck Squamous Cell Carcinoma. The site is secure. HPV status should be included as an important risk and prognostic factor in future trials. Fregonesi PA, Teresa DB, Duarte RA, Neto CB, Oliveira M, Soares CP. This analysis has a number of strengths. Chapter First Online: 06 May 2022 Abstract Immunohistochemistry (IHC) is a technique whereby antigens (proteins) that are present in a cell are detected by the use of antibodies that bind to the antigens. Careers. and M.H.S. The study set of 1100 cervical biopsies were divided into 4 reading sets of 275 cases each stratified by CPR CIN diagnoses to ensure readers all saw a similar spectrum of cases. Mills AM, Paquette C, Castle PE, et al. (P = 0.001) and who observed that there is more probability of p16 overexpression in later stage and high-grade tumor.[14,22,28]. One is the cost and logistics of performing p16 IHC on all biopsies. government site. Please enable scripts and reload this page. p16 and Other Epithelial Cancer Biomarkers. Focal distribution (>10%30% of labeled nuclei and cytoplasm strongly positive, spreading in one tissue area) was considered as moderate expression (Grade II) and sporadic positivity (5%10% of nuclei and cytoplasm with weak and scattered positivity as low expression (Grade I).[11]. An official website of the United States government. Two studies 25, 26 provided results for p16 INK4a interpretation as p16 INK4a positive or negative, . The readers and the pathologist agreed on p16 IHC scoring for 42 (84%) of the 50 slides of CIN less severe than CIN2 and 37 (74%) of the 50 CIN2+ slides. Positive and negative controls were run simultaneously. 4. On the basis of PPA and NPA for CIN2+ on H&E-stained slides compared with the CPR, the 70 ISPs were divided into tertiles. ISPs who favor specificity over sensitivity show a 21% difference in PPA, regardless of whether or not they requested a p16 based on the LAST criteria. In a second round after a washout period of at least 4 weeks, ISPs read the same respective sets of 275 tissue specimens, however, using H&E as well as p16 IHC plus negative reagent control IHC-stained slides (ISPH&E+p16). Although the results of studies are contradictory, abnormal p16 immunohistochemistry does not reliably predict risk of progression of low grade cervical squamous lesions. Moreover, the average differences in PPA were either identical or very similar for LAST cases and non-LAST cases within all 3 tertiles. You may search for similar articles that contain these same keywords or you may to maintaining your privacy and will not share your personal information without Its major function is to inhibit cyclin-dependent kinases (CDK4 and CDK6), which are required to phosphorylate the retinoblastoma protein (pRb). [10,11,21,22], Histological grading is a method of quantitating the degree of differentiation by applying a set of histopathological criteria. Stacey M. Gargano MD a , Christopher Sebastiano MD a , The mean age of the males and females was 46.03 14.33 years and 50.08 14.91 years, respectively. As HPV integration with the transcription of viral oncoprotein induces overexpression of p16, we can use p16 immunohistochemistry as a surrogate marker of HPV. The working group concluded that only p16INK4a immunohistochemistry (p16 IHC) had sufficient evidence of clinical utility to be recommended for routine clinical use and they developed specific recommendations for situations where pathologists should utilize p16 IHC.12 These recommendations are widely referred to as the LAST criteria and were developed specifically with a desire to discourage and prevent inappropriate use or overuse of any biomarker(s).12, Since the publication of the LAST p16 IHC criteria, several studies have documented the usefulness of following the criteria. Federal government websites often end in .gov or .mil. are consultants to Ventana Medical Systems Inc (Roche Tissue Diagnostics), Roche Molecular Diagnostics, BD Lifesciences, and Inovio. Depending on whether CPRH&E or CPRH&E+p16 is used as the reference diagnosis, the average difference in NPA (ie, specificity) was only 0.8 to 1.5% in the non-LAST cases. and Dragomir et al. Materials and methods: History of alcohol abuse was present in 24 patients, of which 16 (66.67%) had positive p16 expression. 2020 Nov;33(6):869-877. doi: 10.1111/pcmr.12902. Cervical histopathology variability among laboratories: a population-based statewide investigation. As there is wide variation in how often ISPs requested p16 per the LAST criteria as well as considerable differences in the PPA and NPA of ISPs compared with the reference diagnosis, we investigated whether pooling the results of all ISPs together might be obscuring meaningful differences of the impact of the LAST criteria on ISPs with different diagnostic approaches. A pathologist reviewed all 100 cases. Conclusion Our data revealed that high expression (> 50%) of p16 is low in oropharyngeal squamous cell carcinoma in our setup. You may be trying to access this site from a secured browser on the server. The p16 (CDKN2a/INK4a) tumor-suppressor gene in head and neck squamous cell carcinoma: A promoter methylation and protein expression study in 100 cases. Out of 60 cases with p16 positivity, 43 (70.2%) were <50 years of age, 47 (78.33%) were males and 53 (88.33%) had cancer in the oral cavity. Majority of our patients were tobacco users (86 patients), which 54 (62.79%) cases had positive p16 expression. Figure 1 shows the distribution of the average frequencies at which the 70 ISPs requested adjunctive p16 staining during round 1.