European Journal of Cardiovascular Medicine

Breast diseases comprise a heterogeneous group of inflammatory, benign, proliferative, and malignant lesions and represent one of the leading causes of morbidity among women worldwide. Breast carcinoma is currently the most frequently diagnosed malignancy among women and remains a major cause of cancer-related mortality. Early and accurate diagnosis is essential for timely therapeutic intervention and improved patient outcomes. [1,2]

The evaluation of breast lesions is based on the principle of triple assessment, which integrates clinical examination, radiological imaging, and pathological evaluation. When these three components are concordant, the diagnostic accuracy approaches nearly 100%, thereby reducing unnecessary surgical procedures and facilitating appropriate treatment planning. [3-5].

Fine-needle aspiration cytology (FNAC) is an established first-line diagnostic procedure for palpable breast lesions because it is rapid, minimally invasive, inexpensive, and associated with minimal patient discomfort. The procedure provides reliable cytomorphological assessment with a short turnaround time and can be repeated whenever required. Owing to these advantages, FNAC continues to play a significant role in developing countries and resource-limited healthcare settings where access to core needle biopsy may be restricted. [6-8]

Radiological assessment using ultrasonography and mammography has been standardized through the Breast Imaging Reporting and Data System (BI-RADS) developed by the American College of Radiology. BI-RADS provides a uniform reporting system, facilitates communication between radiologists and clinicians, stratifies the risk of malignancy, and guides further diagnostic management. Correlation of BI-RADS assessment with cytological findings enhances diagnostic confidence and supports multidisciplinary decision-making. [5,9]

Histopathological examination remains the reference standard for the definitive diagnosis of breast lesions. Correlation of cytological findings with histopathology enables assessment of the diagnostic performance of FNAC, identifies causes of diagnostic discordance, and contributes to continuous quality improvement in breast cytopathology. [10,11]

Although core needle biopsy has gained widespread acceptance because of its ability to provide tissue architecture and facilitate ancillary investigations, FNAC continues to be an effective diagnostic modality owing to its simplicity, rapid reporting, cost-effectiveness, and high diagnostic accuracy when interpreted by experienced cytopathologists. Previous studies have demonstrated sensitivity and specificity exceeding 90%, supporting the continued role of FNAC as an integral component of triple assessment. [8]

The present prospective observational study was therefore undertaken to evaluate the cytomorphological spectrum of breast lesions diagnosed by FNAC and to determine its diagnostic accuracy by correlating cytological findings with BI-RADS categorization and histopathological examination.

Study Design and Setting

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 to evaluate the diagnostic utility of fine-needle aspiration cytology (FNAC) in breast lesions by correlating cytological findings with BI-RADS categorization and histopathological examination.

Study Population

A total of 200 consecutive patients presenting with clinically palpable breast lesions were enrolled. Patients of either sex and all age groups fulfilling the eligibility criteria were included after obtaining written informed consent.

Eligibility Criteria

Inclusion Criteria

• Patients presenting with palpable breast lumps.
• Patients providing written informed consent.
• Patients undergoing FNAC with available clinical and radiological information.
• Patients with histopathological follow-up wherever surgical specimens were available.

Exclusion Criteria

• Patients declining participation.
• Patients with incomplete clinical information.
• Previously treated recurrent breast malignancies.
• Unsatisfactory aspirates despite repeat aspiration.

Clinical & Radiological Assessment

Detailed clinical information, including age, sex, duration of symptoms, laterality, site of the lesion, pain, nipple discharge, family history of breast carcinoma, previous breast surgery, and provisional clinical diagnosis, was recorded for all patients. A comprehensive local examination of both breasts and regional lymph nodes was performed before cytological evaluation.

Radiological evaluation was performed using ultrasonography, mammography, or both, depending on the patient's age and clinical indication. Breast lesions were categorized according to the American College of Radiology Breast Imaging Reporting and Data System (BI-RADS) into categories 1–6. Radiological findings were subsequently correlated with cytological and histopathological diagnoses. [5,9]

Fine-Needle Aspiration Cytology & Histopathology

FNAC was performed under aseptic precautions using a 22–23-gauge disposable needle attached to a 10-mL disposable syringe. Air-dried smears were stained with May–Grünwald–Giemsa (MGG) stain, whereas alcohol-fixed smears were stained using the Papanicolaou (Pap) staining method. Additional Haematoxylin and Eosin (H&E) staining was performed whenever indicated. Cytological diagnoses were classified into standard categories: Unsatisfactory/Inadequate, Benign (C2), Atypical (C3), Suspicious for malignancy (C4), and Malignant (C5). [6,10,12].

Histopathological examination was available for 110 patients who underwent surgical procedures (excisional biopsy, tru-cut biopsy, lumpectomy, or modified radical mastectomy). Tissue specimens were fixed in 10% neutral buffered formalin, processed routinely, embedded in paraffin, sectioned at 3–5 μm, and stained with H&E. Histopathology served as the reference standard. [10,11]

Statistical Analysis

Data were entered into Microsoft Excel and analyzed using appropriate statistical methods. Continuous variables were expressed as mean ± standard deviation (SD), whereas categorical variables were summarized as frequencies and percentages. Histopathology was considered the reference standard for calculating sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy. Associations between categorical variables were assessed using the Chi-square test, and a p-value <0.05 was considered statistically significant.

Ethical Considerations

The study was approved by the Institutional Ethics Committee, KM University, Mathura (Approval No. KMU/RO/EECC/2023-24/52). Written informed consent was obtained from all participants before enrollment. Confidentiality of patient information was maintained throughout the study in accordance with the Declaration of Helsinki.

A total of 200 patients presenting with palpable breast lesions were included in the study. The mean age was 42.5 ± 12.8 years. The highest proportion of patients belonged to the 31–45-year age group (39.0%), followed by 46–60 years (29.0%), 18–30 years (24.0%), and >60 years (8.0%) (p<0.001). Lesions were almost equally distributed between the right (51.5%) and left (48.5%) breasts. The mean duration of symptoms before presentation was 5.2 ± 3.1 months (Table 1).

Table 1. Baseline Clinicodemographic Characteristics of the Study Population (N=200)

The upper outer quadrant was the most frequently involved site (49.0%), followed by the upper inner quadrant (16.0%), lower outer quadrant (13.0%), central/subareolar region (13.0%), and lower inner quadrant (9.0%) (p<0.001) (Table 2).

Table 2. Distribution of Breast Lesions According to Quadrant Location

Malignant lesions were observed predominantly in patients aged 46 years and above, whereas benign lesions were more common in younger patients (p<0.001) (Table 3). Hard consistency on clinical examination was significantly associated with malignant lesions, while most benign lesions were soft in consistency (p<0.001) (Table 4).

Table 3. Distribution of Benign and Malignant Lesions According to Age Group

Table 4. Consistency of Breast Lesions According to Final Diagnosis

Malignant lesions also demonstrated a significantly larger mean ultrasound size than benign lesions (3.4 ± 1.3 cm vs. 2.1 ± 0.8 cm; p<0.001) (Table 5). A positive family history of breast carcinoma was significantly associated with malignant lesions (p=0.008) (Table 6).

Table 5. Comparison of Ultrasound Size Between Benign and Malignant Lesions

Table 6. Association of Family History with Final Histopathological Diagnosis

FNAC classified 128 (64.0%) lesions as benign, 14 (7.0%) as atypical (C3), 12 (6.0%) as suspicious for malignancy (C4), and 46 (23.0%) as malignant (C5) (p<0.001). Among benign lesions, fibroadenoma was the commonest diagnosis (82/128, 64.1%), followed by fibrocystic disease (21.9%). Among malignant and suspicious lesions, invasive ductal carcinoma (IDC) predominated, accounting for 41 of 58 cases (70.7%) (Table 7).

Table 7. Distribution of Breast Lesions Based on FNAC Diagnosis (N=200)

Radiological evaluation demonstrated that BI-RADS 2 was the most common category (39.0%), followed by BI-RADS 4 (26.0%), BI-RADS 3 (22.0%), and BI-RADS 5 (13.0%) (p<0.001). Overall concordance between radiological and cytological assessment was 86.0% (172/200) (Table 8).

Table 8. Distribution of BI-RADS Categories (N=200)

Histopathological examination was available for 110 patients. Of these, 64 (58.2%) lesions were malignant and 46 (41.8%) were benign (Table 9). Comparison of FNAC with histopathology showed excellent diagnostic agreement (p<0.001) (Table 10).

Table 9. Histopathological Diagnosis of the Study Cohort (n=110)

Table 10. Correlation Between FNAC and Histopathological Diagnosis (n=110)

Using histopathology as the reference standard and considering C3–C5 categories as test-positive, FNAC demonstrated 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% (Table 11).

Table 11. Diagnostic Performance Parameters of FNAC

Six discordant cases were identified (Table 12). Four false-negative cases were attributed to sampling errors, cystic degeneration, deep location, or technical artifact. Two false-positive/atypical cases were benign on final excision.

Table 12. Analysis of Discordant Cases Between FNAC and Histopathology

When all three modalities (clinical/radiological assessment, FNAC, and histopathology) were integrated, 98 of 110 cases (89.1%) demonstrated complete concordance, 10 cases (9.1%) showed partial concordance, and only 2 cases (1.8%) exhibited complete discordance (p<0.001) (Table 13, 14).

Table 13. Triple Assessment Concordance Rates

Table 14. Correlation Between BI-RADS Category and Histopathological Diagnosis

The present prospective observational study evaluated the diagnostic accuracy of FNAC in palpable breast lesions by correlating cytological findings with BI-RADS categorization and histopathological examination. FNAC demonstrated excellent diagnostic performance (sensitivity: 93.8%, specificity: 95.7%, accuracy: 94.5%). These findings reaffirm the role of FNAC as a highly dependable component of triple assessment. [8,10,11]

Most patients belonged to the 31–45-year age group, while malignant lesions predominated in women aged 46 years and older. This age distribution aligns closely with established global epidemiological patterns of breast disease. [1,2,13]

Benign lesions constituted the majority of cases, with fibroadenoma being the most common diagnosis. Among malignancies, invasive ductal carcinoma (IDC) was predominant, matching global WHO classifications and standard epidemiological reference data. [10,11,13]

Standardized BI-RADS reporting showed strong concordance with cytology and histopathology, supporting its role in guiding clinical management and stratifying risks effective pre-operatively. [5,9] Discordances were primarily attributable to sampling error, cystic degeneration, deep-seated lesions, or overlapping cytological features. High sensitivity and specificity confirm that FNAC remains an indispensable first-line investigation, especially in resource-limited settings where cost-effectiveness and turnaround time are critical. [8,10,12]

Strengths and Limitations

The major strengths of this study include its prospective design, inclusion of 200 consecutive patients, and comprehensive correlation of FNAC findings with both BI-RADS categorization and histopathological examination.

The study has certain limitations. It was conducted at a single tertiary care centre, which may limit generalizability. Histopathological correlation was available only for patients undergoing biopsy/surgery. Additionally, ancillary techniques such as immunocytochemistry were not routinely performed.

Clinical Implications

The findings reinforce the continued importance of FNAC as a primary diagnostic tool. Integrating FNAC with standardized BI-RADS reporting minimizes unnecessary surgical procedures, supports timely clinical decision-making, and provides a cost-effective diagnostic pathway in resource-constrained environments

reliable, safe, minimally invasive, and cost-effective diagnostic modality for the evaluation of palpable breast lesions. In the present study, FNAC demonstrated high sensitivity (93.8%), specificity (95.7%), and overall diagnostic accuracy (94.5%). Correlation of FNAC findings with BI-RADS categorization and histopathological examination significantly improves diagnostic confidence. The findings support the continued use of FNAC as an effective first-line diagnostic tool for palpable breast lesions in routine clinical practice.

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