Background: Cervical cancer remains a major public health concern globally, particularly in low- and middle-income countries, and is strongly associated with persistent infection by high-risk human papillomavirus (hrHPV). Early detection of preneoplastic and neoplastic lesions is critical to improve clinical outcomes, yet conventional cytology and HPV DNA testing have limitations in sensitivity and specificity. Immunohistochemical markers such as p16 and SOX2 have emerged as potential biomarkers for identifying high-grade lesions and invasive carcinoma. This study aimed to evaluate the expression of p16 and SOX2 across preneoplastic and neoplastic cervical lesions and to explore their correlation with histopathological diagnosis and each other.
Methods: A cross-sectional study was conducted at the Department of Pathology, Sree Balaji Medical College and Hospital, Chennai, India, from July 2023 to June 2025. Forty histologically confirmed cervical lesions—including low-grade squamous intraepithelial lesion (LSIL, n = 13, 32.5%), high-grade squamous intraepithelial lesion (HSIL, n = 12, 30%), and squamous cell carcinoma (SCC, n = 15, 37.5%)—were analyzed using immunohistochemistry for p16 and SOX2. Expression was evaluated based on staining intensity and proportion of positive cells. Statistical analysis was performed using Chi-square tests, and p < 0.05 was considered significant.
Results: Overexpression of p16 was observed in 14/15 SCC cases (93.3%) and 11/12 HSIL cases (91.7%), while low or negative expression predominated in LSIL (9/13, 69.2%). SOX2 expression increased progressively from LSIL (0/13, 0%) to HSIL (10/12, 83.3%) and SCC (9/15, 60%). Co-expression analysis revealed that among 21 SOX2-positive cases, 20 (95.2%) also demonstrated p16 overexpression, indicating strong concordance (χ² = 15.60, p < 0.001). Both markers demonstrated statistically significant associations with lesion severity.
Conclusion: The study confirms that p16 and SOX2 are significantly upregulated in high-grade and invasive cervical lesions, with strong concordance between the two markers. Combined assessment of p16 and SOX2 enhances detection of high-risk lesions, aids in risk stratification, and supports improved clinical management of cervical cancer, highlighting their utility as complementary immunohistochemical biomarkers.
Keywords: Cervical cancer, p16, SOX2, Immunohistochemistry, Preneoplastic lesions, Squamous cell carcinoma
How to cite this article: Shinitha IR, Shobana B, Divyalakshmi PK, A Study on Immunohistochemical Expression of P16 And SOX2 in Preneoplastic and Neoplastic Lesions of Cervix among Patients attending a Tertiary Care Hospital. Int J Drug Deliv Technol. 2026;16(5s): 278-288; DOI: 10.25258/ijddt.16.5s.36
Source of support: Nil
Conflict of interest: None