TY - JOUR TI - p16/Ki-67 Dual Staining Is a Reliable Biomarker for Risk Stratification for Patients with Borderline/Mild Cytology in Cervical Cancer Screening AU - Magkana, M. AU - Mentzelopoulou, P. AU - Magkana, E. AU - Pampanos, A. AU - Vrachnis, N. AU - Kalafati, E. AU - Daskalakis, G. AU - Domali, E. AU - Thomakos, N. AU - Rodolakis, A. AU - Anagnou, N.P. AU - Pappa, K.I. JO - ANTICANCER RESEARCH PY - 2022 VL - 42 TODO - 5 SP - 2599-2606 PB - International Institute of Anticancer Research SN - 0250-1291 TODO - 10.21873/anticanres.15738 TODO - cyclin dependent kinase inhibitor 2A; Ki 67 antigen, early cancer diagnosis; female; human; papillomavirus infection; risk assessment; staining; uterine cervix carcinoma in situ; uterine cervix tumor, Cervical Intraepithelial Neoplasia; Cyclin-Dependent Kinase Inhibitor p16; Early Detection of Cancer; Female; Humans; Ki-67 Antigen; Papillomavirus Infections; Risk Assessment; Staining and Labeling; Uterine Cervical Neoplasms TODO - Background/Aim: 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. Patients and Methods: All 759 enrolled patients were tested for cytology, high-risk human papillomavirus (HR-HPV) and dual p16/Ki-67 staining. Results: 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. Conclusion: 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. © 2022 International Institute of Anticancer Research. All rights reserved. ER -