Abstract
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.
Highlights
Introduction published maps and institutional affilCervical cancer is one of the most common gynecological malignancies
We evaluated the correlation and distribution of p16 and Ki-67 in patients with human papilloma virus (HPV)
We evaluated the correlation between histological grade of low (CIN1), high-grade intraepithelial cervical lesions CIN2+ (CIN2 and CIN3), and in situ carcinoma (CIS) with the immunohistochemical (IHC) expression of p16/Ki-67 and HR-HPV infection as presented in the flow chart (Figure 1)
Summary
Cervical cancer is one of the most common gynecological malignancies. Screening programs for cervical cancer have been developed in many countries, most of them being based on cervical cytology (Pap smear). According to the data available in the literature, approximately 30% of patients with cervical cancer may have at least 1 previous falsenegative cytological result. In order to reduce the incidence of the disease, more accurate screening methods are needed [1]. The importance of persistent human papilloma virus (HPV) infection in the etiopathogenesis of cervical cancer draws attention to HPV genotyping as a possible method for primary screening. The high rate of transient HPV infections causes HPV genotyping to have low specificity for high-grade cervical lesions, especially in young women [2,3]
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