p16ink4a is a surrogate marker for high-risk and malignant cervical lesions in the presence of human papillomavirus.

OBJECTIVE To strengthen the role of high-risk human papillomaviruses (HPVs) in the development of cervical cancer, and the association between HPV and the cell cycle inhibitor gene p16ink4a in cervical carcinogenesis. METHODS In this study, the association between p16ink4a and the presence of HPV DNA in cervical lesions was investigated in a total of 177 cervical biopsies classified as benign (n = 42), low-grade squamous intraepithelial lesions (LSIL; n = 34), high-grade squamous intraepithelial lesions (HSIL; n = 48) and invasive cancer (n = 53). p16ink4a expression was analyzed by immunohistochemistry while HPV DNA was localized by in situ hybridization. RESULTS No significant association was found between p16ink4a expression and HPV presence in benign and LSIL samples. In HSIL and invasive cancer, a significant association was found between p16ink4a overexpression and the presence of HPV DNA. CONCLUSION Immunohistochemical p16ink4a expression is associated with HPV infection in HSIL and cervical cancer, suggesting a role of p16 as a biomarker of HPV-associated cervical lesions.