Interobserver reproducibility of cytologic p16INK4a/Ki-67 dual immunostaining in human papillomavirus-positive women

Cancer Cytopathology

Volumn 125, Issue 3, 2017, Pages 212-220

  Benevolo, Maria ^a   Allia, Elena ^b   Gustinucci, Daniela ^c   Rollo, Francesca ^a   Bulletti, Simonetta ^c   Cesarini, Elena ^c   Passamonti, Basilio ^c   Giovagnoli, Maria Rosaria ^d   Carico, Elisabetta ^d   Carozzi, Francesca M ^e   Mongia, Alessandra ^e   Fantacci, Giulia ^e   Confortini, Massimo ^e   Rubino, Teresa ^f   Fodero, Cristina ^f   Prandi, Sonia ^f   Marchi, Natalina ^g   Farruggio, Angelo ^g   Coccia, Anna ^b   Macrì, Luigia ^b   Ghiringhello, Bruno ^b   Ronco, Guglielmo ^b   Bragantini, Emma ^h   Polla, Enzo ^h   Maccallini, Vincenzo ⁱ   Negri, Giovanni ^j   Giorgi Rossi, Paolo ^f,k   Barca, Alessandra ^l   Quadrino, Francesco ^l   Vocaturo, Amina ^a   Scalfari, Manuela ^a   Fabbri, Giulia ^a   Bonvicini, Laura ^k   Andersson, Karin ^e   Bisanzi, Simonetta ^e   Capassoni, Stefania ^e   Pierro, Carmelina Di ^e   Iossa, Anna ^e   Matucci, Marzia ^e   Mantellini, Paola ^e   Pompeo, Giam Paolo ^e   Puliti, Donella ^e   Baldini, Andrea ^e   Rizzolo, Raffaella ^b   Gillio Tos, Anna ^b   De Marco, Laura ^b   Barbareschi, Mattia ^h   Palma, Paolo Dalla ^h   Girlando, Salvatore ^h   Pusiol, Teresa ^h   Condini, Sara ^h   Martinelli, Nadia ^c   Vinti, Gabriella ^c   Principi, Graziella ^c   Fabra, Arturo ^c   Lucaccioni, Antonella ^c   Carlani, Angela ^c   Giaimo, Maria Donata ^c   Penon, Maria Gabriella ^g   Bertazzo, Alessandra ^g   Mistro, Annarosa Del ^m   Frayle, Helena ^m   Rizzi, Martina ^m   Gori, Silvia ^m   Zorzi, Manuel ⁿ   Fedato, Chiara ^o   Montaguti, Adriana ^o   more..

^a REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

^b Unit of Cancer Epidemiology   (Italy)

^c Regional Health Authority of Umbria   (Italy)

^d SAPIENZA UNIVERSITY OF ROME   (Italy)

^e Institute for Cancer Study and Prevention   (Italy)

^f S MARIA NUOVA HOSPITAL   (Italy)

^g Unit 17   (Italy)

^h Provincial Centre for Health Services   (Italy)

ⁱ and L'Aquila Local Health Trust Abruzzo   (Italy)

^j CENTRAL HOSPITAL OF BOLZANO   (Italy)

^k Local Health Authority of Reggio Emilia   (Italy)

^l Regional Park Agency   (Italy)

^m Veneto Oncology Institute   (Italy)

ⁿ Tumor Registry of the Veneto Region   (Italy)

^o Veneto Regional Coordinated Screening Oncology   (Italy)

more..

Author keywords

cervical cancer; cyclin dependent kinase inhibitor 2A (p16ink4a) Ki 67; dual immunostaining; human papillomavirus; inter rater agreement

Indexed keywords

CYCLIN DEPENDENT KINASE INHIBITOR 2A; KI 67 ANTIGEN; VIRUS DNA;

ARTICLE; CANCER SCREENING; CONTROLLED STUDY; CYTOPATHOLOGY; FEMALE; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; LABORATORY TEST; PAPILLOMAVIRUS INFECTION; REPRODUCIBILITY; UTERINE CERVIX CYTOLOGY; OBSERVER VARIATION; PAPILLOMAVIRUS INFECTIONS; PRECANCEROUS CONDITIONS; UTERINE CERVICAL NEOPLASMS;

CYCLIN-DEPENDENT KINASE INHIBITOR P16; FEMALE; HUMANS; KI-67 ANTIGEN; OBSERVER VARIATION; PAPILLOMAVIRUS INFECTIONS; PRECANCEROUS CONDITIONS; REPRODUCIBILITY OF RESULTS; UTERINE CERVICAL NEOPLASMS;

EID: 85008262661     PISSN: 1934662X     EISSN: 19346638     Source Type: Journal    
DOI: 10.1002/cncy.21800     Document Type: Article

References (33)

1. Ronco G, Dillner J, Elfstrom KM, et al. Efficacy of HPV-based Screening for Preventing Invasive Cervical Cancer: follow-up of European randomised controlled trials. Lancet. 2014;383:524–532.
2. Anttila A, Arbyn M, de Vuyst H, et al. eds. European Commission European Guidelines for Quality Assurance in Cervical Cancer Screening. 2nd ed. Supplements. Luxembourg: Office for Official Publications of the European Communities; 2015.
3. Saslow D, Solomon D, Lawson HW, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol. 2012;137:516–542.
4. Moyer VA, US Preventive Services Task Force. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;156:880–891.
5. von Knebel Doeberitz M. New markers for cervical dysplasia to visualise the genomic chaos created by aberrant oncogenic papillomavirus infections. Eur J Cancer. 2002;38:2229–2242.
6. Carozzi F, Confortini M, Dalla Palma P, et al. and the NTCC Working Group. Use of p16 overexpression to increase the specificity of human papillomavirus testing: a study nested in the NTCC randomised controlled trial. Lancet Oncol. 2008;9:937–945.
7. Bergeron C, Ikenberg H, Sideri M, et al. and PALMS Study Group. Prospective evaluation of p16/Ki-67 dual-stained cytology for managing women with abnormal Papanicolaou cytology: PALMS study results. Cancer Cytopathol. 2015;123:373–3781.
8. Carozzi F, Gillio-Tos A, Confortini M, et al. Risk of high-grade cervical intraepithelial neoplasia during follow-up in HPV-positive women according to baseline p16-INK4A results: a prospective analysis of a nested substudy of the NTCC randomized controlled trial. Lancet Oncol. 2013;14:168–176.
9. Gustinucci D, Giorgi Rossi P, Cesarini E, et al. Use of cytology, E6/E7 mRNA and p16INK4a-Ki67 to define the management of human papillomavirus (HPV) positive women in cervical cancer screening. Am J Clin Pathol. 2016;145:35–45.
10. Fehrmann F, Laimins LA. Human papillomaviruses: targeting differentiating epithelial cells for malignant transformation. Oncogene. 2003;22:5201–5207.
11. zur Hausen H. Immortalization of human cells and their malignant conversion by high risk human papillomavirus genotypes. Semin Cancer Biol. 1999;9:405–411.
12. Dona MG, Vocaturo A, Giuliani M, et al. p16/Ki-67 dual staining in cervico-vaginal cytology: correlation with histology, human papillomavirus detection and genotyping in women undergoing colposcopy. Gynecol Oncol. 2012;126:198–202.
13. Tornesello ML, Buonaguro L, Giorgi-Rossi P, Buonaguro FM. Viral and cellular biomarkers in the diagnosis of cervical intraepithelial neoplasia and cancer [serial online]. Biomed Res Int 2014:519619, 2013.
14. Liang J, Mittal KR, Wei JJ, Yee H, Chiriboga L, Shukla P. Utility of p16INK4a, CEA, Ki67, P53 and ER/PR in the differential diagnosis of benign, premalignant, and malignant glandular lesions of the uterine cervix and their relationship with Silverberg scoring system for endocervical glandular lesions. Int J Gynecol Pathol. 2007;26:71–75.
15. Longatto Filho A, Utagawa ML, Shirata NK, et al. Immunocytochemical expression of p16INK4A and Ki-67 in cytologically negative and equivocal pap smears positive for oncogenic human papillomavirus. Int J Gynecol Pathol. 2005;24:118–124.
16. Aoyama C, Liu P, Ostrzega N, Holschneider CH. Histologic and immunohistochemical characteristics of neoplastic and nonneoplastic subgroups of atypical squamous lesions of the uterine cervix. Am J Clin Pathol. 2005;123:699–706.
17. Tsoumpou I, Arbyn M, Kyrgiou M, et al. p16INK4a immunostaining in cytological and histological specimens from the uterine cervix: a systematic review and meta-analysis. Cancer Treat Rev. 2009;35:210–220.
18. Wentzensen N, Bergeron C, Cas F, Eschenbach D, Vinokurova S, von Knebel DM. Evaluation of a nuclear score for p16INK4a-stained cervical squamous cells in liquid-based cytology samples. Cancer. 2005;105:461–467.
19. Allia E, Ronco G, Coccia A, et al. Interpretation of p16(INK4a)/Ki-67 dual immunostaining for the triage of human papillomavirus-positive women by experts and nonexperts in cervical cytology. Cancer Cytopathol. 2015;123:212–218.
20. Wentzensen N, Fetterman B, Tokugawa D, et al. Interobserver reproducibility and accuracy of p16/Ki-67 dual-stain cytology in cervical cancer screening. Cancer Cytopathol. 2014;122:914–920.
21. Solomon D, Davey D, Kurman R, et al. Bethesda 2001 Workshop. The 2001 Bethesda System: terminology for reporting results of cervical cytology. JAMA. 2002;287:2114–2119.
22. Fleiss JL. Measuring nominal scale agreement among many raters. Psychol Bull. 1971;76:378–382.
23. Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37–46.
24. Reichenheim ME. Confidence intervals for the kappa statistic. Stata J. 2004;4:421–428.
25. Stata Corporation. Stata Statistical Software. Release 13 [software program]. College Station, TX: StataCorp LP; 2013.
26. Arbyn M, Ronco G, Cuzick J, Wentzensen N, Castle PE. How to evaluate emerging technologies in cervical cancer screening? Int J Cancer. 2009;125:2489–2496.
27. Bergeron C, Giorgi-Rossi P, Cas F, et al. Cytology for triaging HPV-positive women: substudy nested in the NTCC randomized controlled trial [serial online]. J Natl Cancer Inst. 2015;107. pii: dju423.
28. Stoler MH, Schiffman M; Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion Triage Study (ALTS) Group. Interobserver reproducibility of cervical cytologic and histologic interpretations: realistic estimates from the ASCUS-LSIL Triage Study. JAMA. 2001;285:1500–1505.
29. Confortini M, Bondi A, Cariaggi MP, et al. Interlaboratory reproducibility of liquid-based equivocal cervical cytology within a randomized controlled trial framework. Diagn Cytopathol. 2007;35:541–544.
30. Confortini M, Di Stefano C, Biggeri A, et al. Daily peer review of abnormal cervical smears in the assessment of individual practice as an additional method of internal quality control. Cytopathology. 2016;27:35–42.
31. Branca M, Alieri S, Cialdea L, Morosini P. Survey of performance of cervical cytopathology laboratories and of screening programs in Italy. National Working Group for Quality Assurance in Cytohistopathology. Tumori. 1990;76:434–438.
32. Vinyuvat S, Karalak A, Suthipintawong C, et al. Interobserver reproducibility in determining p16 overexpression in cervical lesions: use of a combined scoring method. Asian Pac J Cancer Prev. 2008;9653–9657.
33. Schmidt D, Bergeron C, Denton KJ, Ridder R; European CINtec Cytology Study Group. p16/ki-67 dual-stain cytology in the triage of ASCUS and LSIL Papanicolaou cytology: results from the European equivocal or mildly abnormal Papanicolaou cytology study. Cancer Cytopathol. 2011;119:158–166.