Role of Dual-Staining p16/Ki-67 in the Management of Patients under 30 Years with ASC-US/L-SIL

• Published in: Diagnostics (Basel) Vol. 12; no. 2; p. 403
• Main Authors: Secosan, Cristina, Pasquini, Andrea, Zahoi, Delia, Motoc, Andrei, Lungeanu, Diana, Balint, Oana, Ilian, Aurora, Balulescu, Ligia, Grigoras, Dorin, Pirtea, Laurentiu
• Format: Journal Article
• Language: English
• Published: Switzerland MDPI AG 04.02.2022; MDPI
• Subjects: Accuracy; Age; Biopsy; Cellular biology; Cervical cancer; colposcopy; HPV; Human papillomavirus; immunohistochemistry; immunostaining; Infections; Ki-67; p16; Pap smear; Patients; Womens health; United States > US; Germany; Ki-67; colposcopy; immunostaining; immunohistochemistry; p16; HPV
• DOI: 10.3390/diagnostics12020403
• ISSN: 2075-4418

Patients diagnosed with low-grade squamous intraepithelial lesion ((L-SIL) or atypical squamous cells of undetermined significance (ASC-US) are subjected to additional investigations, such as colposcopy and biopsy, to rule out cervical intraepithelial neoplasia 2+ (CIN 2+). Especially in young patients, lesions tend to regress spontaneously, and many human papilloma virus (HPV) infections are transient. Dual-staining p16/Ki-67 has been proposed for the triage of patients with ASC-US or L-SIL, but no prospective study addressing only this subgroup of patients has been conducted so far. We performed a prospective study including all eligible patients referred for a loop electrosurgical excision procedure (LEEP) in the Department of Obstetrics and Gynecology of Timișoara University City Hospital. HPV genotyping and dual-staining for p16/Ki-67 were performed prior to LEEP, at 6 and 12 months after LEEP. A total of 60 patients were included in the study and completed the follow-up evaluation. We analyzed the sensitivity and specificity for biopsy-confirmed CIN2+ using the 95% confidence interval (CI) of high-risk human papilloma virus (HR-HPV), dual-staining p16/Ki-67, colposcopy, and combinations of the tests on all patients and separately for the ASC-US and L-SIL groups. Dual-staining p16/Ki-67 alone or in combination with HR-HPV and/or colposcopy showed a higher specificity that HR-HPV and/or colposcopy for the diagnosis of biopsy confirmed CIN2+ in patients under 30 years. Colposcopy + p16/Ki-67 and HR-HPV + colposcopy + p16/Ki-67 showed the highest specificity in our study.