p16/Ki-67 Dual Staining Is a Reliable Biomarker for Risk Stratification for Patients With Borderline/Mild Cytology in Cervical Cancer Screening

• Published in: Anticancer research Vol. 42; no. 5; pp. 2599 - 2606
• Main Authors: Magkana, Maria, Mentzelopoulou, Panagiota, Magkana, Ekaterini, Pampanos, Andreas, Vrachnis, Nikolaos, Kalafati, Eleni, Daskalakis, Georgios, Domali, Ekaterini, Thomakos, Nikolaos, Rodolakis, Alexandros, Anagnou, Nicholas P, Pappa, Kalliopi I
• Format: Journal Article
• Language: English
• Published: Greece International Institute of Anticancer Research 01.05.2022
• Subjects: Abnormalities; Biomarkers; Cancer screening; Cellular biology; Cervical cancer; Cervical Intraepithelial Neoplasia - diagnosis; Cervix; Cyclin-Dependent Kinase Inhibitor p16; Cytology; Dysplasia; Early Detection of Cancer; Female; Human papillomavirus; Humans; Ki-67 Antigen; Medical screening; Papillomavirus Infections - diagnosis; Risk; Risk Assessment; Staining; Staining and Labeling; Uterine Cervical Neoplasms - diagnosis; Pap test; screening; risk stratification; CIN3; CIN2; p16/Ki-67 dual-stained cytology; cervical cancer; triage; HPV; HSIL
• ISSN: 0250-7005; 1791-7530
• DOI: 10.21873/anticanres.15738

To evaluate p16/Ki-67 dual-staining performance for detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in the management of women with minor cervical abnormalities. All 759 enrolled patients were tested for cytology, high-risk human papillomavirus (HR-HPV) and dual p16/Ki-67 staining. Positivity rates for HR-HPV and dual staining increased as dysplasia was worsened from non-CIN (37.6% and 0%) to CIN1 (62.5% and 1.6%) and CIN2+ (98.7% and 97.3%), respectively. HPV18 and HPV16 exhibited the highest odds ratios (53.16 and 11.31) in the CIN2+ group. Both p16/Ki-67 dual staining and HR-HPV presented similar sensitivities (97.3% and 98.7%, respectively) for CIN2+ detection. Dual staining specificity, however, was 99.3%, significantly higher compared to HR-HPV testing (52.2%). The utility of dual staining was evaluated in different screening strategies and appeared to reduce the number of colposcopies required for the detection of CIN2+ cases. p16/Ki-67 dual-staining cytology is a surrogate triage biomarker in cytology-based screening programs, with high performance for efficient risk stratification of women with mild cervical abnormalities.