Diagnostic Accuracy of Fine-Needle Aspiration Cytology in Breast Lesions: Correlation with BI-RADS and Histopathological Findings—A Prospective Observational Study
Background: Breast lesions comprise a heterogeneous group of inflammatory, benign, proliferative, and malignant disorders and represent one of the commonest causes of surgical consultation among women. Accurate preoperative diagnosis is essential for appropriate patient management. Fine-needle aspiration cytology (FNAC), together with clinical examination and radiological assessment, forms the cornerstone of the triple assessment approach. Despite advances in breast imaging and core needle biopsy, FNAC remains a rapid, minimally invasive, cost-effective, and reliable diagnostic modality, particularly in resource-limited healthcare settings. Objectives: To evaluate the diagnostic accuracy of fine-needle aspiration cytology in breast lesions and determine its correlation with Breast Imaging Reporting and Data System (BI-RADS) categorization and histopathological findings. Materials and Methods: A prospective observational study was conducted in the Department of Pathology, KM Medical College and Hospital, Mathura, Uttar Pradesh, India, after obtaining approval from the Institutional Ethics Committee (Approval No. KMU/RO/EECC/2023-24/52). The study was carried out over a two-year period from May 2024 to April 2026. A total of 200 consecutive patients presenting with palpable breast lesions underwent FNAC with clinicoradiological correlation. Histopathological examination was available in 110 cases and served as the reference standard for assessing the diagnostic performance of FNAC. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy were calculated. Results: Benign breast lesions constituted the majority of cases, with fibroadenoma being the most frequent diagnosis. Malignant lesions were more common in women aged over 40 years, with invasive ductal carcinoma representing the predominant malignant tumour. FNAC demonstrated excellent agreement with histopathological findings, showing a sensitivity of 93.8%, specificity of 95.7%, positive predictive value of 96.8%, negative predictive value of 91.7%, and an overall diagnostic accuracy of 94.5%. Increasing BI-RADS categories showed a statistically significant association with malignant cytological and histopathological diagnoses (p < 0.001).Conclusion: Fine-needle aspiration cytology is a highly reliable, minimally invasive, and cost-effective diagnostic technique for the evaluation of palpable breast lesions. Correlation with BI-RADS assessment and histopathological examination significantly improves diagnostic confidence and supports the continued role of the triple assessment approach in the diagnosis and management of breast diseases.