School of Medicine, National and Kapodistrian University of Athens, Athens, Greece;
Department of Genetics, Alexandra Hospital, Athens, Greece.
Anticancer Res. 2022 May;42(5):2599-2606. doi: 10.21873/anticanres.15738.
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.
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.
背景/目的：评估 p16/Ki-67 双染在处理宫颈轻度病变患者中用于检测宫颈上皮内瘤变 2 级或更高级别（CIN2+）的性能。
所有 759 例入组患者均接受细胞学、高危型人乳头瘤病毒（HR-HPV）和 p16/Ki-67 双染检测。
随着从非 CIN（37.6%和 0%）到 CIN1（62.5%和 1.6%）和 CIN2+（98.7%和 97.3%），HR-HPV 和双染的阳性率逐渐升高。在 CIN2+组中，HPV18 和 HPV16 的比值比（OR）最高（53.16 和 11.31）。p16/Ki-67 双染和 HR-HPV 对 CIN2+的检测均具有相似的敏感性（97.3%和 98.7%）。然而，双染的特异性为 99.3%，显著高于 HR-HPV 检测（52.2%）。双染在不同的筛查策略中的应用价值被评估，它似乎可以减少为检测 CIN2+病例而需要进行的阴道镜检查数量。
p16/Ki-67 双染细胞学是细胞学筛查方案中的替代分流生物标志物，对具有宫颈轻度病变的女性进行高效的风险分层具有较高的性能。
