Breast diseases represent a significant proportion of surgical cases in both developed and developing countries. A frequent challenge in clinical practice is the need to differentiate benign from malignant lesions before initiating definitive treatment. With advancements in patient awareness and the implementation of screening programs, the detection of breast tumors has significantly increased (1).

The most common presenting feature of breast disease is a palpable mass. However, patients may also present with inflammatory changes, nipple discharge, or abnormalities detected through imaging (2). While the majority of breast lumps are benign (3), patients often experience considerable anxiety until they undergo specialist evaluation, appropriate investigations, and receive a definitive diagnosis (4).

In many cases, clinical examination alone is insufficient to determine the exact nature of a suspicious breast lump. Therefore, a reliable diagnostic method that is accurate, simple, reproducible, patient-friendly, and feasible in a busy outpatient setting without the need for complex preparation or costly equipment is essential.

In the 1960s and 70s, Torsten Lowhagen and colleagues at the Karolinska Institute in Stockholm pioneered and popularized Fine-Needle Aspiration Cytology (FNAC), a minimally invasive technique. FNAC is now a well-established and widely accepted method for evaluating breast lumps and plays a critical role when clinical assessment is inconclusive. It has been demonstrated that FNAC can reduce the number of unnecessary open biopsies (5).

Trucut biopsy has more recently gained popularity, particularly in cases where the breast lump is clinically suspicious for malignancy. It reinforces benign diagnoses and enables earlier identification of malignancy in cases where clinical signs are not overt (6). Its true value lies in confirming malignancy when other diagnostic methods yield inconclusive results. Trucut biopsy is now considered a suitable alternative to FNAC in many cases and is capable of accurately determining the nature of the lesion (7).

Although FNAC has been criticized for potential false-negative results in malignant lesions, improved techniques and experienced cytologists have significantly increased its diagnostic reliability. In fact, an unequivocally malignant report from a skilled cytologist is now widely accepted as adequate justification for proceeding with definitive surgery.

This study aims to evaluate the correlation between FNAC findings and Trucut biopsy results in patients presenting with palpable breast lumps. It also investigates the accuracy of tumor localization during FNAC by comparing aspirates containing normal glandular cells with those containing tumor cells. As all breast lumps were palpable, ultrasound guidance was not used during FNAC procedures.

Type of Study: This was a prospective, observational study designed to assess and compare the diagnostic accuracy of Fine Needle Aspiration Cytology (FNAC) and Trucut biopsy in evaluating palpable breast lumps, with histopathological examination as the gold standard.

The study was conducted at Gandhi Medical College and Hospital, Secunderabad, a tertiary care teaching hospital. Female patients attending the outpatient department with complaints of palpable breast lumps formed the study population.

Study Period: The study was carried out over a period of 13 months, from December 2023 to January 2025.

Sample Size: A total of 50 female patients with clinically detectable palpable breast lumps were enrolled consecutively, based on inclusion and exclusion criteria.

Inclusion Criteria:

• Female patients aged between 10 and 70 years.
• Patients presenting with a palpable breast lump of any duration.

Exclusion Criteria:

• Patients with acute inflammatory lesions like breast abscess.
• Ulcerated breast masses with skin breakdown.
• Patients with recurrent breast lumps following prior surgery for confirmed breast malignancy.
• Patients who were not willing to undergo surgical procedures or provide informed consent.
• Cases with obvious locally advanced breast cancer (e.g., skin infiltration or fixed masses) that warranted immediate definitive treatment.

Methodology

Clinical Evaluation: All patients underwent detailed history-taking and physical examination. Clinical details such as age, lump duration, symptoms, and menstrual and reproductive history were recorded using a structured proforma.

Fine Needle Aspiration Cytology (FNAC): FNAC was performed using a 10 ml syringe with a 23-gauge needle. After skin sterilization, the lump was stabilized and aspirated. The collected material was smeared on glass slides, fixed in 95% methyl alcohol, and stained with Papanicolaou or Giemsa stains. A single cytopathologist interpreted the slides and categorized them as benign, suspicious, malignant, or inadequate. Repeat FNAC was done for inadequate samples before proceeding to Trucut biopsy.

Needle Tip Localization Accuracy: The accuracy of tumor localization during FNAC was assessed by comparing aspirates with tumor cells to those containing only normal glandular tissue. As all lumps were palpable, ultrasound guidance was not used.

Trucut Biopsy: Following local anesthesia with 2% lignocaine, a 5 mm skin incision was made. A Trucut biopsy needle was inserted into the lump, and four core samples were obtained from different angles. Specimens were fixed in 10% formalin and sent for histopathology

.

Histopathological Confirmation: All Trucut and surgical specimens (mastectomy or modified radical mastectomy) were examined histopathologically, serving as the reference standard for diagnosis.

Definitive Surgical Management: Patients with confirmed malignancy underwent surgical intervention. Final histopathology reports were used to validate FNAC and Trucut biopsy results.

Statistical Analysis: Data were analyzed using Microsoft Excel 2007. Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for FNAC and Trucut biopsy against final histopathology. Rates of inadequate FNAC samples and successful tumor localization were also evaluated.

Ethical Considerations: Prior to the commencement of the study, ethical approval was obtained from the Institutional Ethics Committee. All patients were informed about the nature, purpose, and benefits of the study. Written informed consent was obtained from all participants before inclusion.

Table 1: Age-wise Distribution of Patients with Benign and Malignant Breast Lesions (N = 50)

This table 1 presents the age-wise distribution of patients with palpable breast lumps, highlighting differences between benign and malignant cases. The majority of cases (40%) were in the 15–20 year age group, predominantly with benign lesions (46.3%). Malignant lesions were more common in older age groups, particularly among patients aged 31–40 years, accounting for 77.7% of all malignancies. The mean age for benign cases was 23.49 ± 6.35 years, while that for malignant cases was notably higher at 32.78 ± 6.53 years.

Table 2: Distribution of Breast Lesions by Side and Quadrant (N = 50)

            NS = Not significant

This table 2 summarizes the laterality and quadrant-wise distribution of breast lesions among the study participants. Benign lesions were more commonly observed on the right breast (80.5%), while malignant lesions showed a relatively balanced distribution, though slightly more on the right side (55.6%). However, the difference was not statistically significant (p = 0.113). The upper outer quadrant was the most frequent site for both benign (65.9%) and malignant (77.8%) lesions, consistent with the known higher glandular density in that region. Other quadrants showed minimal involvement, and a central lesion was noted only in one malignant case. None of these associations were statistically significant (p = 0.202), but the pattern aligns with existing literature on common locations for breast pathology.

Table 3: Duration and Symptoms of Breast Lesions (N = 50)

             *Significant at p < 0.05; NS = Not Significant

This table 3 presents the distribution of breast lesions based on symptom duration and clinical presentation. The majority of both benign (78%) and malignant (66.7%) cases had symptom durations of ≤6 months. Although malignant cases had a longer mean duration (9.00 ± 6.32 months) compared to benign ones (5.85 ± 4.77 months), the difference was not statistically significant (p = 0.098). Regarding symptoms, pain was reported only in benign cases (14.6%) and was absent in malignant ones, though not statistically significant (p = 0.221). In contrast, nipple discharge and axillary lump were significantly more common in malignant lesions (p = 0.010 and <0.001, respectively), suggesting these as important clinical indicators for malignancy.

Table: FNAC Report Distribution in Study Subjects (N = 50)

The Fine Needle Aspiration Cytology (FNAC) findings in this study revealed that the majority of breast lumps were benign. Fibroadenoma was the most frequently diagnosed lesion, accounting for 84% of cases, followed by fibroadenosis (6%) and fibrocystic disease (2%). Malignant cytology was reported in 6% of cases, and 2% were labeled as suspicious.

Table 5: Diagnostic Performance of FNAC and Trucut Biopsy in Breast Lesions (N = 50)

This table 5 shows the comparative diagnostic accuracy of Fine Needle Aspiration Cytology (FNAC) and Trucut biopsy in identifying benign and malignant breast lesions. FNAC showed high sensitivity for benign lesions (95.1%) but low specificity (22.2%), indicating a higher rate of false positives. Conversely, for malignant lesions, FNAC had high specificity (95.1%) but low sensitivity (22.2%), suggesting a greater likelihood of missing malignancies.

Trucut biopsy demonstrated superior overall performance, with high sensitivity and specificity for both benign (95.1% and 77.8%, respectively) and malignant lesions (66.7% and 95.1%, respectively). Its diagnostic accuracy was higher for both benign (92.0%) and malignant lesions (90.0%) compared to FNAC (both at 82.0%). These findings confirm that while FNAC remains a useful initial screening tool, Trucut biopsy provides more reliable diagnostic outcomes, particularly for confirming malignancy.

In this study, we assessed the diagnostic accuracy of Fine Needle Aspiration Cytology (FNAC) and Trucut biopsy in evaluating palpable breast lumps, with final histopathological examination (HPE) as the reference standard. The majority of our study population comprised young females, with benign lesions commonly occurring in the second and third decades of life, while malignant lesions were more prevalent in older age groups. This age distribution is consistent with earlier findings by Olu-Edd et al. (2011) and Saha et al. (2016), who reported that fibroadenomas are more common in younger women, whereas malignancies tend to present in those over 30 years (8, 9). Clinically, pain and shorter duration of symptoms were more common in benign lesions, whereas malignant lumps were more frequently associated with nipple discharge and axillary lymphadenopathy. The presence of these symptoms in malignant cases was statistically significant and supports similar observations by Tripathi et al. (2022).

FNAC demonstrated a high sensitivity (95.1%) for detecting benign lesions but showed a much lower specificity (22.2%), which led to a higher false-positive rate. For malignant lesions, FNAC had low sensitivity (22.2%) but high specificity (95.1%), reflecting its limited ability to reliably identify cancer when only cytological features are examined. These limitations have also been reported by Singh et al. (2011), who found that FNAC often falls short in cases requiring architectural assessment or when cellular atypia is borderline (11). In contrast, Trucut biopsy outperformed FNAC in almost all diagnostic parameters. It showed 95.1% sensitivity and 77.8% specificity for benign lesions, and 66.7% sensitivity with 95.1% specificity for malignant lesions, resulting in overall diagnostic accuracy rates of 92% and 90%, respectively. These findings are in agreement with Mitra et al. (2016), who emphasized the superiority of Trucut biopsy in providing histological detail essential for definitive diagnosis and treatment planning (12).

While FNAC remains useful as a first-line screening test due to its simplicity, rapidity, and minimal invasiveness especially in clinically benign cases its limitations become apparent in the context of suspicious or atypical lesions. In contrast, Trucut biopsy offers better tissue architecture and is more conclusive, particularly in diagnosing malignancies and determining histological subtypes, as supported by studies from Frederiksen et al. (2015) (13). In our study, Trucut biopsy also demonstrated better concordance with final histopathology than FNAC. Therefore, in cases with inconclusive FNAC results or clinical suspicion of malignancy, Trucut biopsy should be the preferred diagnostic approach.

FNAC is a valuable and minimally invasive diagnostic tool for initial evaluation of breast lumps, particularly in young women with likely benign disease. However, due to its limited accuracy in detecting malignancy, FNAC results should be interpreted with caution, and Trucut biopsy should be performed for confirmation in suspicious cases. Trucut biopsy, when performed by experienced hands, shows high sensitivity and specificity and aligns closely with final histopathological diagnosis, making it an essential tool in the diagnostic workup of breast lesions.

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