All world-wide recommended algorithms in cervical cancer secondary prevention have limitations in precancers detection. Simultaneus co-expression of anti-proliferative and proliferative proteins in p16/Ki67 test is clinically used to select high-grade cervical intraepithelial lesions. We evaluated whether twice-positivity p16/Ki67 test – in first test and in one year follow-up – can improve detection of these.
8824 automated proceeded LBC (a study period 08/2015 – 04/2017), including 2063 as cotesting with DNA high-risk HPV, have been performed in secondary cervical cancer prevention. Immunocytochemical p16/Ki67 double staining was done in 372 cases using automated preparation system. 180 women with ASC-H or higher or ASC-US/LSIL cytology and with HPV-positive status were referred to colposcopy with biopsy. 35 patients with histological LSIL or less (biopsy first-negativity), reached follow-up cotesting with p16/Ki67 test and biopsy in 12-18 months.
Diagnostic value of twice-positivity p16/Ki67 test for histologic HSIL (hHSIL) in the second follow-up biopsy was evaluated. Follow-up p16/Ki67 test was positive in 11 women – 8 hHSIL and 3 histologic LSIL cases were diagnosed in biopsy. 1 hHSIL was p16-Ki67 twice-negative. Sensitivity/specificity/PPV/NPV of p16/Ki67 for hHSIL in the second biopsy was 89/88/73/96 (CI 95%) respectively.
A twice-positive p16/Ki67 test can be a precise biomarker in triage patients for hHSIL-risk in cervical cancer screening. In women with abnormal screening test results after first biopsy, p16/Ki67 could be sufficient as alone diagnostic test in referring to follow-up biopsy in 12-18 months.