p16INK4a and Ki-67 measurement predict progression of cervical low-grade squamous intraepithelial lesion.

Objective: To describe the natural history of low-grade squamous intraepithelial lesion/cervical intraepithelial neoplasia grade I (LSIL/CIN1), and to analyze the predictive values of p16INK4a and Ki-67 for LSIL/CIN1 progression.

Methods: From January 2013 to January 2016, 264 patients were diagnosed with CIN1 by colposcopy-assisted biopsy and were followed up at 1-year intervals at Peking University People's Hospital. We measured expression levels of biomarkers p16INK4a and Ki67 to predict progression, persistence, or regression of the disease. We used chi-square tests and logistic regression analysis to explore the relationships among LSIL/CIN1 progression, p16INK4a/Ki-67 expression, and patient age.

Results: Among 264 patients with LSIL/CIN1, p16INK4a, Ki-67 expression and patient age > 30 years old were significantly associated with progression. Univariate analysis showed that age was not a risk factor for progression (P > 0.05) but that p16INK4a and Ki-67 expression were significantly associated with the progression (P < 0.05). Multivariate analysis showed that p16INK4a-positivity and high expression of Ki-67 protein were associated with LSIL/CIN1 progression, with odds ratios (OR) and 95% confidence intervals (CI) of 10.95 (3.04-39.53), and 9.7 (2.77-34.03), respectively.

Conclusion: p16INK4a-positivity and high expression of Ki-67correlated with LSIL/CIN1 progression. These markers may be independent predictors of LSIL/CIN1 progression.