Efficacy of P16 in Biopsy Samples in the Diagnosis of High Grade Cervical Intraepithelial Neoplasia — An Observational Study

Abstract

Introduction: Invasive cervical cancer is preceded by a precancerous lesion known as cervical intraepithelial neoplasia (CIN). The majority of low-grade CIN lesions (CIN-1) spontaneously resolve without any medication, with only a tiny percentage progressing to high-grade lesions (CIN 2 and CIN 3) and cervical cancer. Objective: To evaluate the performance of P16 in the diagnosis of high-grade cervical intraepithelial neoplasia in biopsy samples at a Bangladeshi tertiary care facility. Methods and Materials: This retrospective observational study was conducted at Bangabandhu Sheikh Mujib Medical University in Dhaka. The study focused on 75 cases with histological diagnoses of CIN 2 and CIN 3/CIS. These cases were selected from the pathology department's archive, covering the period from June 2014 to December 2015. The fresh H&E sections and previous H&E sections were examined. 47 cases were ultimately available for examination after meeting the selection criterion. Of these 47 instances, 11 had CIN 3, and 36 had a CIN 2 diagnosis. All underwent P16 immunostaining. Results: Out of the 47 cases, 36 were diagnosed as CIN 2 (76.59 %) and 11 cases as CIN 3 (23.40%). The age of the study patients ranged from 25 to 70 years with a mean age of 41.4 +11.5 years. Around 60% of the study patients belonged to the age group 31- 50 years. In all 11 (100%) of the CIN 3 cases, P16 immunostain was found positive. 10 (27.77%) of the CIN 2 cases had positive P16 immunostain results. Conclusion: Because of the presence of immature squamous metaplasia, reactive epithelial alterations, atrophy, or tangential sectioning, the diagnosis of CIN 2 exhibits intraobserver and interobserver variability.