Breast diseases are showing rising trend worldwide. Wide spectrum of disorders ranging from self-limiting inflammatory lesion, benign breast lesion to life-threatening invasive carcinoma arises from breast. Breast lumps are common in women and typically present with pain, a palpable mass, and nipple discharge.2

Benign breast diseases constitute a heterogeneous group of disorders, including developmental abnormality, epithelial and stromal proliferations, inflammatory lesions, and neoplasm.

Breast cancer constitutes around 11.6% of cancers and overall, it is the second most common cancer.1 Breast cancer is the most diagnosed cancer among women globally and a leading cause of cancer-related mortality. Therefore, early detection and accurate diagnosis are critical in improving prognosis and reducing mortality.

Fine Needle Aspiration Cytology (FNAC) is an effective tool for evaluating both palpable and non-palpable breast masses, offering high accuracy, particularly for palpable lesions.5

FNAC is particularly useful in outpatient settings, offering a same-day preliminary diagnosis and helping guide the management plan. Despite its advantages, FNAC has limitations, especially in differentiating between certain benign and malignant lesions or in diagnosing atypical ductal hyperplasia and ductal carcinoma in situ. Histopathological examination, on the other hand, remains the gold standard for definitive diagnosis.

Several studies have documented a high degree of correlation between FNAC and histopathological findings, with reported sensitivity ranging from 85% to 98% and specificity from 90% to 100%. Nevertheless, discrepancies can arise due to sampling error, poor cellularity, or interpretative challenges, necessitating a clinicopathological correlation.

The present study aims to evaluate the diagnostic efficacy of FNAC in breast lesions by comparing its findings with those of histopathology. This correlation is essential not only to validate the use of FNAC as a frontline diagnostic modality but also to identify its limitations, thereby minimizing false negatives and false positives that could adversely affect patient outcomes.

In summary, a comprehensive clinicopathological correlation will facilitate a better understanding of FNAC's role and effectiveness in diagnosing various breast lesions through histopathological correlation, ultimately leading to more accurate diagnosis and improved patient care.

A retrospective study was conducted over a period of 24months (Jan 2023-Dec-2024) at the Department of Pathology, MRH, involving 120 female patients presenting with palpable breast lumps. All patients provided informed consent. A detailed clinical history and physical examination were conducted prior to the procedures.

Inclusion Criteria:

• Female patients aged 18 to 75 years.
• Presence of a palpable breast lump.
• Patients who undergo both FNAC and subsequent excision biopsy.

Exclusion Criteria:

• Patients with previously diagnosed breast malignancies
• Patients who received chemotherapy or radiotherapy before FNAC
• Non-palpable lesions detected solely by imaging
• Inadequate or inconclusive FNAC smears

.

Procedure: FNAC was performed using a 22–23-gauge needle with a 10 mL disposable syringe under aseptic conditions. Multiple passes were made and aspirated material was smeared on glass slides. Air-dried smears were stained with May-Grünwald-Giemsa (MGG) and alcohol-fixed smears with Papanicolaou stain.

FNAC classifies lesions into five categories according to the International Academy of Cytology (IAC) Yokohama System: C1 (inadequate), C2 (benign), C3 (probably benign), C4 (suspicious of malignancy), and C5 (malignant).6,7

The patients then underwent excisional biopsy or mastectomy depending on clinical evaluation and FNAC results. The histopathological findings were considered the gold standard.

The diagnostic yield of FNAC was evaluated by calculating sensitivity, specificity, PPV, NPV, and overall accuracy by comparing the FNAC results with histopathological findings. Concordance rates were determined for each category of lesion. Discrepant cases were reviewed independently by two senior pathologists.

Statistical Analysis: Data were analyzed using SPSS version 20.0. Descriptive statistics, chi-square tests were used to assess agreement between FNAC and histopathology.

This methodology ensures reliable comparison between FNAC and histopathological findings and provides valuable insight into the diagnostic efficacy of FNAC in breast lesion evaluation.

A total of 120 cases were evaluated. Based on FNAC, 80 (66.7%) were benign, 36 (30%) were malignant, and 4 (3.3%) were suspicious. Histopathology confirmed 82 benign and 38 malignant lesions. Suspicious cases on FNAC (n=4) were later resolved via histopathology.

Table 1: Distribution of Breast Lesions by FNAC and Histopathology

Table 2-Distribution of FNAC categories (IAC YOKOHAMA Classification)

Table 3: Concordance between FNAC and Histopathology

In table 3, Further interpretation of concordance data reveals that among 80 benign FNAC cases, 78 matched histopathology and 2 were discordant (false negatives). All 36 malignant FNAC cases were confirmed on histology (no false positives), reflecting FNAC’s strong diagnostic reliability in identifying malignancies. However, the 4 cases labeled suspicious on FNAC were all discordant, emphasizing the importance of further histopathological evaluation for indeterminate findings.

Table 4: Statistical Analysis of FNAC

In table 4, Sensitivity is 94.7% indicating FNAC effectively identified true positive cases (malignant lesions). Specificity was 100% demonstrating its accuracy in ruling out malignancy in benign cases. Positive Predictive Value (PPV) are 100% showing that most cases diagnosed as malignant by FNAC were confirmed histologically. Negative Predictive Value (NPV) are 97.5% confirming that the benign FNAC results were mostly accurate. Overall Accuracy is 98.3% reflecting FNAC’s general consistency and dependability.

Table 5: FNAC and Histopathological Correlation of Benign Lesions

Table 6: FNAC and Histopathological Correlation of Malignant Lesions

Table 7: Discrepant Cases Analysis

The present study demonstrates a high degree of concordance between FNAC and histopathological examination in the diagnosis of breast lesions. With a diagnostic accuracy of 98.3%, FNAC has shown its utility as a valuable preliminary tool in evaluating palpable breast lumps. The sensitivity (94.7%) and specificity (98%) observed in this study align well with previously published reports.

Several earlier studies have reported comparable results. For instance, a study by Park et al⁸. reported a sensitivity of 77% and specificity of 96% in differentiating benign from malignant breast lesions using FNAC. These findings are correlated by our study and reinforce the reliability of FNAC as a frontline diagnostic modality.

Table-8-Various studies with distribution of breast lesions

The sensitivity was 92.86%, meaning that FNAC correctly identified 39 out of 42 true positive cases. The specificity was 100%, indicating no false positives among the 94 true negative cases. The positive predictive value was also 100%, showing that all positive FNAC results were accurate. Additionally, the negative predictive value was 96.91%, reflecting a high rate of correctly identifying true negatives.⁹. In a study by Muddegowda et al.¹⁴, FNAC showed excellent diagnostic accuracy (97%), specificity (98%), and sensitivity (94.5%), preventing unnecessary surgeries.

Both these studies are strongly in concordance with our study.

False-negative results are primarily due to sampling errors, especially in small lesions (<1cm) which are harder to sample even with modern high-resolution ultrasonography.¹⁵

Table-9- Concordance between Diagnostic Methods Assessed by Statistical Analysis.

FNAC is a highly effective, minimally invasive diagnostic modality for the initial evaluation of breast lesions. This study demonstrated a strong correlation between FNAC and histopathological diagnosis, with high sensitivity, specificity, and diagnostic accuracy. FNAC was particularly reliable in diagnosing both benign conditions like fibroadenoma and malignant entities such as invasive ductal carcinoma. However, a small percentage of suspicious or discordant cases underscore the need for histopathological confirmation, especially in cases with indeterminate cytological findings. The study reinforces the value of FNAC in clinical practice, especially in low-resource settings where rapid decision-making is vital. Nonetheless, FNAC should be used in conjunction with clinical assessment and histopathological confirmation to ensure diagnostic accuracy and optimal patient care.

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