Palpable breast lumps are a frequent clinical concern encountered in women of all age groups, often causing anxiety due to the potential risk of malignancy. These lumps can arise from a wide variety of pathologies, ranging from benign conditions such as fibroadenoma and fibrocystic changes to malignant lesions like invasive ductal carcinoma. Early diagnosis and appropriate categorization of these lumps are crucial for timely treatment, improved prognosis, and reduced patient morbidity and mortality. Among the available diagnostic modalities, Fine Needle Aspiration Cytology (FNAC) has emerged as a rapid, simple, minimally invasive, and cost-effective technique for the initial assessment of palpable breast masses [1]. Globally, breast cancer is the most common cancer diagnosed in women, accounting for 11.7% of all cancer cases worldwide. According to the GLOBOCAN 2020 report, there were 2.3 million new cases and approximately 685,000 deaths attributed to breast cancer globally, making it the leading cause of cancer-related mortality among women [2]. In India, breast cancer has become the most common malignancy among women, surpassing cervical cancer, with an incidence of over 178,000 cases annually and a steadily increasing trend, especially in urban areas [3]. The age-adjusted incidence rate of breast cancer in Indian women ranges from 25.8 to 41 per 100,000, and the mortality-to-incidence ratio remains relatively high, reflecting delayed detection and diagnosis [4]. Despite advancements in imaging and histopathology, FNAC continues to play a vital role in the “triple assessment” of breast lumps — which includes clinical examination, radiological imaging (ultrasound/mammography), and cytology. FNAC is particularly valuable in resource-limited settings where advanced imaging or core needle biopsy facilities may not be readily available. Its advantages include high patient compliance, low complication rate, quick turnaround time, and the ability to provide preliminary diagnosis guiding surgical decisions [5]. In a large meta-analysis, FNAC showed a sensitivity of 92.7% and specificity of 94.8%, highlighting its reliability in distinguishing benign from malignant lesions [6]. However, FNAC has its limitations, such as sampling errors, inadequate smears, and difficulty in grading certain malignant lesions or detecting in situ carcinomas. These limitations have led to the introduction of the International Academy of Cytology Yokohama System, which standardizes FNAC reporting into five categories, improving diagnostic reproducibility and clinician communication [7]. When interpreted within clinical and radiological context, FNAC results correlate well with histopathological outcomes, particularly for benign lesions such as fibroadenomas and malignant lesions like ductal carcinoma [8]. In India, particularly in rural and semi-urban regions like Gujarat, breast cancer awareness and access to diagnostic facilities remain suboptimal. A study by Parmar et al. in Gujarat reported that over 60% of breast cancer cases presented in late stages, mainly due to delays in diagnosis and lack of initial cytological evaluation [9]. At GMERS Medical College, Vadnagar — which serves a predominantly rural population — FNAC is routinely used as a first-line investigation for evaluating breast lumps prior to histopathological confirmation. However, limited local studies have evaluated its diagnostic accuracy in this specific setting, thereby necessitating institutional data to support its continued utility. Therefore, the present study is undertaken to assess the diagnostic performance of FNAC in palpable breast lumps by comparing cytological findings with histopathological examination (HPE) results. The study aims to analyze the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of FNAC and identify common diagnostic pitfalls. The findings are expected to reinforce the role of FNAC as an effective screening and diagnostic modality, particularly in resource-constrained settings, and contribute to early detection and management of breast diseases in the regional population.

This was a cross-sectional observational study conducted in the Department of Pathology at GMERS Medical College, Vadnagar, Gujarat, over a period of six months, from August 2024 to January 2025. The study aimed to evaluate the diagnostic utility of Fine Needle Aspiration Cytology (FNAC) in patients presenting with palpable breast lumps and to correlate the cytological findings with subsequent histopathological diagnoses. A total of 45 patients with clinically palpable breast lumps attending the surgical outpatient department or admitted to the hospital were included in the study. Patients were selected based on convenience sampling after obtaining informed consent. All age groups and both genders were included, though the majority of cases were females. Patients with non-palpable lumps, recurrent malignancy, previously biopsied lesions, or inadequate FNAC samples were excluded from the study. Each patient underwent a detailed clinical examination followed by FNAC of the breast lump under aseptic conditions using a 22–23 gauge needle attached to a 10 mL disposable syringe. Smears were prepared on clean glass slides and stained using Giemsa and Papanicolaou stains. The cytological diagnosis was categorized using the International Academy of Cytology (IAC) Yokohama System, which includes five categories: Inadequate (C1), Benign (C2), Atypical (C3), Suspicious for Malignancy (C4), and Malignant (C5). All patients subsequently underwent surgical excision or core biopsy of the lump, and the specimens were processed for histopathological examination (HPE) using standard hematoxylin and eosin staining. The histopathological diagnosis was considered the gold standard for comparison. Data regarding age, gender, site, cytological category, and histopathological findings were entered into Microsoft Excel and analyzed using SPSS software version [insert version]. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy of FNAC were calculated by comparing FNAC results with final histopathological diagnosis. Descriptive statistics were used to summarize the data, and the chi-square test was applied to assess statistical correlation. A p-value < 0.05 was considered statistically significant.

In the present study, a total of 45 patients presenting with palpable breast lumps were evaluated using Fine Needle Aspiration Cytology (FNAC), and the findings were subsequently correlated with histopathological examination (HPE). The majority of patients were females (93.3%), with the most common age group being 31–50 years. The left breast was more frequently involved, and the upper outer quadrant was the most common site of the lump. Among all cases, benign lesions constituted the majority, with fibroadenoma being the most frequently diagnosed entity on both cytology and histopathology. Based on FNAC, 26 cases (57.8%) were categorized as benign (C2), 4 cases (8.9%) as atypical (C3), 3 cases (6.7%) as suspicious for malignancy (C4), and 10 cases (22.2%) as malignant (C5), while 2 cases (4.4%) were inadequate (C1). Histopathological examination revealed 25 benign and 18 malignant lesions, with 2 cases showing benign phyllodes and inflammatory pathology. FNAC findings showed a high degree of correlation with histopathology, especially in clearly benign and malignant categories. When cytological diagnoses were compared to histopathology, the overall sensitivity of FNAC was 94.4%, specificity was 96.0%, positive predictive value (PPV) was 94.4%, and negative predictive value (NPV) was 96.0%, with an overall diagnostic accuracy of 95.6%. Only two cases were discordant: one case of fibroadenoma with atypia was overdiagnosed as suspicious on cytology, and one case of invasive ductal carcinoma was underdiagnosed as atypical. These discrepancies were mainly due to sampling error and overlapping features in cytomorphology. The results reaffirm that FNAC is a highly effective initial diagnostic tool for evaluating palpable breast lumps, especially in settings where rapid and minimally invasive diagnosis is essential for early treatment planning. Its strong correlation with histopathology supports its continued role in the diagnostic algorithm of breast lesions. Table 1: Demographic and Clinical Profile of Study Participants (n = 45) Parameter Frequency (n) Percentage (%) Gender Female 42 93.3% Male 3 6.7% Age Group (years) < 30 10 22.2% 31 – 50 24 53.3% > 50 11 24.5% Side of Involvement Right Breast 19 42.2% Left Breast 26 57.8% Quadrant Involved Upper Outer Quadrant 22 48.9% Upper Inner Quadrant 7 15.6% Lower Outer Quadrant 5 11.1% Lower Inner Quadrant 4 8.9% Central 7 15.6% Table 2: Distribution of Cases According to FNAC and Histopathological Diagnosis FNAC Category (IAC System) Number of Cases (n) Percentage (%) C1 – Inadequate 2 4.4% C2 – Benign 26 57.8% C3 – Atypical 4 8.9% C4 – Suspicious for Malignancy 3 6.7% C5 – Malignant 10 22.2% Histopathological Diagnosis Number of Cases (n) Percentage (%) Benign Lesions (e.g., Fibroadenoma, Fibrocystic) 25 55.6% Malignant Lesions (e.g., IDC) 18 40.0% Others (e.g., Phyllodes, Inflammatory) 2 4.4% Table 3: Diagnostic Accuracy of FNAC Compared to Histopathology Diagnostic Parameter Value (%) Sensitivity 94.4% Specificity 96.0% Positive Predictive Value (PPV) 94.4% Negative Predictive Value (NPV) 96.0% Diagnostic Accuracy 95.6%

In the present study, FNAC was evaluated as a diagnostic tool for palpable breast lumps in 45 patients and its findings were correlated with histopathology, which is considered the gold standard. The majority of cases in this study occurred in females (93.3%), with the highest incidence noted in the 31–50 years age group. This age distribution is consistent with findings by Malvia et al., who reported that the peak age of presentation for both benign and malignant breast lesions in Indian women lies between 30 and 50 years [10]. The left breast was more frequently involved, with the upper outer quadrant being the most common site, similar to the anatomical distribution reported by Khanna et al. [11]. On FNAC, benign lesions (C2 category) were the most common, comprising 57.8% of cases, followed by malignant lesions (C5, 22.2%), and atypical/suspicious categories making up the rest. The most frequent benign diagnosis was fibroadenoma, while invasive ductal carcinoma dominated among malignancies — a pattern that correlates well with studies by Choi et al. and Ahmed et al., who observed a similar lesion profile in Asian and African populations respectively [12,13]. When compared to histopathology, FNAC showed high diagnostic accuracy in our study, with sensitivity of 94.4%, specificity of 96.0%, and overall accuracy of 95.6%. These values are comparable to those reported by Hatada et al., who demonstrated sensitivity and specificity exceeding 92% in their large comparative study [14]. Similarly, a study by Kocjan et al. on FNAC usage in breast lump diagnosis showed diagnostic concordance with histopathology in over 90% of cases [15]. Most discrepancies in our study were seen in the atypical and suspicious categories (C3 and C4), which are known to be inherently ambiguous. One case of invasive carcinoma was underdiagnosed as atypical due to sparse cellularity and poor smear quality — highlighting the importance of adequate sampling and smear technique. The application of the International Academy of Cytology (IAC) Yokohama System in this study helped standardize reporting, improve communication with clinicians, and facilitated better triaging of patients. Studies have shown that the IAC system improves reproducibility and increases confidence in cytological interpretations, especially in borderline categories [16]. Despite this, certain limitations of FNAC remain, including difficulty in identifying in-situ carcinoma, grading of malignancy, and differentiating phyllodes tumor from fibroadenoma — issues also highlighted by Orell et al. [17]. Our findings confirm that FNAC is a highly effective, rapid, and minimally invasive diagnostic tool for initial evaluation of palpable breast lumps, especially in rural or resource-limited settings like ours. Its strong diagnostic concordance with histopathology justifies its use as a frontline investigation. However, in cases with atypical features, repeat aspiration, imaging correlation, or core biopsy should be considered to improve diagnostic precision. CONCLUSION Fine Needle Aspiration Cytology (FNAC) proved to be a highly effective, rapid, and reliable diagnostic tool for the initial evaluation of palpable breast lumps in this study. It demonstrated excellent correlation with histopathological examination, particularly in clearly benign and malignant lesions. With a sensitivity of 94.4%, specificity of 96.0%, and overall diagnostic accuracy of 95.6%, FNAC has shown strong potential to guide clinical decision-making, especially in resource-constrained or rural healthcare settings. Its advantages of being minimally invasive, cost-effective, and well-tolerated by patients make it an indispensable component of the diagnostic algorithm for breast lesions. However, equivocal cytological categories such as atypical and suspicious cases may benefit from supplementary diagnostic tools such as imaging or core needle biopsy. The study reinforces the role of FNAC as a frontline investigation in breast lump evaluation and supports its continued use as a valuable screening and diagnostic modality in both primary and tertiary care setups. Limitations and Recommendations This study, while demonstrating the high diagnostic utility of FNAC in evaluating palpable breast lumps, had certain limitations. The most notable limitation was the relatively small sample size of 45 patients, which may not fully represent the diverse spectrum of breast lesions seen in the general population. Being a single-center study conducted in a rural tertiary care hospital, the findings may have limited generalizability to urban or multi-institutional settings. Additionally, the study did not include non-palpable lesions or evaluate radiological correlation (as part of triple assessment), which could further strengthen diagnostic accuracy. Another limitation was the subjective interpretation involved in cytological reporting, particularly in borderline cases (C3 and C4), which may contribute to diagnostic discrepancies. Based on these limitations, it is recommended that larger, multicentric studies be conducted with broader inclusion criteria and stratified analysis based on age, lesion type, and clinical features. Incorporation of radiological data (ultrasound or mammography) and use of image-guided FNAC for deep-seated or small lesions can further improve accuracy. Standardization of cytological reporting using the IAC Yokohama System should be widely adopted to reduce interobserver variability. Moreover, cases with indeterminate or suspicious FNAC findings should be promptly followed up with core biopsy or surgical excision to avoid delayed diagnosis. Overall, the study highlights the need for integrating FNAC into routine diagnostic protocols, particularly in resource-limited settings, while emphasizing the importance of multidisciplinary evaluation in challenging cases.

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