The impact of p16-Ki67 dual-stain cytology in women screened positive for human papillomavirus.

INTRODUCTION: We evaluated the role of p16-Ki67 dual-stain (DS) cytology in clinical management of HPV-positive women referred to colposcopy. METHODS: Retrospective analysis of a prospectively collected database. HPV-positive women newly referred to colposcopy clinics and who had a valid p16-Ki67 DS results at baseline were included. Data collected included age, HPV partial genotypes, liquid-based cytology and histological diagnosis of cervical lesions at baseline and during follow-up to 5 years. Main outcome measures include the number of CIN2 and CIN3+ at baseline and during the follow-up period. RESULTS: HPV genotypes in the cohort (n = 230) included 36 (15.7%) HPV-16, 17 (7.4%) HPV-18 and 177 (77.0%) HPV-12others. The mean (±2 standard deviations [SD]) age was 49.6 (28.1-71.1) years. At baseline, DS was positive in 76 (33.0%) women overall, and in 63.9%, 35.3% and 26.6% for HPV-16, HPV-18 and HPV-12others groups respectively, (p < 0.0001). Comparing combined NILM-ASCUS category to collective LSIL-HSIL-ASC-H category, the difference in the frequency of DS positivity was statistically significant (p = 0.0014). There were 16 (7.0%) CIN2+, all from the DS-positive group. The median (range) follow-up (n = 172 or 74.8%) period was 825 (187-1561) days, significantly longer (756 vs 944.5 days, p < 0.0140) for DS-negative (n = 103) groups. Three CIN2+ were detected: two from the DS-positive group on day-772 and day-1314, and one from the DS-negative group on day-1432. CONCLUSIONS: Among women attending colposcopy, negative DS cytology indicated an extremely low risk of CIN2+ at baseline and during the following two years, regardless of HPV genotypes and liquid-based cytology status. Manuscript.