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

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 Timisoara 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.