The study was conducted in the Department of Pathology in association with Department of General Surgery, at I.P.G.M.E.&R Hospital, Kolkata. From October, 2012 to March, 2014. Patients presenting with suspicious palpable breast lump/mass clinically and/or radiologically, attending at Breast Clinic and/or General Surgery Outpatient Department (OPD), I.P.G.M.E.&R, Kolkata was taken. The study was performed after obtaining the approval from ethical committee and total 50 cases was selected.

As per treatment protocol patients undergoing all three procedures (Fine Needle Aspiration Cytology and Core Needle Biopsy done at Department of Pathology; subsequent excision surgeries done at Department of General Surgery, were selected. None of the patients had received chemotherapy, radiotherapy, or hormone therapy between CNB and surgical excision. May Grunwald Giemsa (MGG) and Papanicolaou (PAP) staining were performed on cytology smears. Haematoxylin and Eosin (H&E) staining was done on both the CNB and tissue specimens obtained from subsequent excision surgeries to see the histological features. Regarding diagnosis, outcomes of FNAC and CNB were reported using the standard NHSBSP criteria (National Health Service Breast Screening Programme) [Table/Fig-1].

The histological diagnosis obtained from tissue sections from excision specimens were categorised into two broad groups: carcinoma i.e. malignancy- diagnosed and malignancy- not-diagnosed (include all benign, with atypia, suspicious, etc.) following conventional histological protocol for individual diagnosis.

Mean and median values with standard deviation were provided for quantitative variables, whereas proportions represented qualitative variables. The Chi-square test was conducted to assess the relationship between categorical variables including the clinicopathologic parameters of prognostic significance The Fisher’s-exact test was used when expected cell counts were less than five. The inter rater reliability was expressed as kappa coefficient.

During the study period of one and half years, a total of 50 patients were selected. The patient age ranged from 26 to 75 years, mean age being 47.4 years ± 21.4 (2SD). Breast carcinoma most commonly was found in the age group of 31-40 years. There was only one male patient who was included in the study, rest were female. The male patient was later confirmed having carcinoma while 83% of females were diagnosed as malignant and in rest malignancy was not diagnosed. Of females, 22 (44%) were in their premenopausal and rest no (55%) were in their postmenopausal status. Right breasts were involved in 26 (52%) patients and rest of 24 (48%) patients had their lesion in left breast. Right breast involvement was slightly higher than the left (52.4% vs. 47.6%) regarding breast carcinoma. Upper Outer Quadrant (UOQ) of the breast was most commonly involved part (UOQ = 50%) followed by central portion i.e. nipple-areolar region (Central = 14%) by palpable and suspicious breast lump/mass which also corroborated regarding involvement by carcinoma. Among 50 patients, size of the lumps ranged from 3 cm to 12 cm, mean = 6.38+4.33 cm (2SD). Of all 42 patients of confirmed malignancy 27 had their breast lesions>5cm (=64.3%) of size.

Forty patients (40), in whom preoperative sono-mammography were suggestive of malignancy (BI-RADS 5); (Breast Imaging Reporting and Data System) all of them were later confirmed as having malignant lesions by HPE of subsequent excision specimens (malignancy outcome = 100%) and none of the patient who was predicted as having benign lesion (BI-RADS 3) was diagnosed other way as having any malignant lesion by final histopathological examination of excision specimens (malignancy outcome = 0.0%) [Table/Fig-2]. All 40 patients of BI-RADS GRADING-5 were subsequently proved as malignant by subsequent of excision specimens.

Seven patients (7) presented with nipple discharge; skin changes in the form of nipple-retraction, peau-de-orange appearance, etc. were seen in 14 patients at presentation; and palpable axillary lymph node/s was seen in 14. On evaluation of FNAC conducted in the study total 29 patients (58% of all selected patients) were diagnosed as malignant i.e. carcinoma (C5 category) whereas total 35 patients (70% of all selected patients) were diagnosed as malignant (B5 category) by CNB [Table/Fig-3,4]. Of 50 patients, 29 i.e. 58% were confirmed as malignant as assessed by FNAC. Total 35 patients (70% of all selected patients) were diagnosed as malignant i.e. (B5 category). In rest of the patients, CNB could not categorise them as having absolute malignant lesions (benign, with atypia, or suspicious, etc.).

Final confirmatory HPE of excision specimens from subsequent surgery confirmed malignancy i.e. carcinoma in 42 patients (84%) of all the selected patients in the study [Table/Fig-5]. HPE of excision specimens confirmed malignancy in 42 i.e., 84% of all patients.

FNAC showed sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy were 69%, 100%, 100%, 38.1%, and 74% respectively in diagnosing carcinoma [Table/Fig-6]. Of all 50 patients included in the study, FNAC diagnosed breast lesions of 29 patients as malignant all of which were later confirmed as malignant by subsequent final HPE of excision specimen from subsequent surgeries (True Positive= 29). There was no such patient who was preoperatively diagnosed as having malignant lesion on FNAC and later categorised as not having malignant one on confirmation (False Positive= 0). Thirteen such patients were there in whom FNAC did not give diagnosis of malignancy, but confirmatory HPE diagnosed them as having malignant lesions later on (False Negative= 13). In breast lesions of 8 patients both FNAC and confirmatory HPE could not diagnose malignancy definitely (True Negative = 8).

CNB had sensitivity, specificity positive predictive value, negative predictive value, and diagnostic accuracy of 88.3%, 100%, 100%, 53.3% and 86% [Table/Fig-7]. Of 35 patients, who were categorized as malignant (B5) by CNB, all were confirmed as malignant by subsequent HPE of excision specimens (100% positive predictive value).

False negativity was lower in case of CNB than that of FNAC (7 cases vs.13 cases). Both FNAC and CNB showed statistically significant correlation with confirmatory HPE of excision specimen (p-value <0.05) in the diagnosis of breast carcinoma. Statistically significant correlation was also seen in between FNAC and CNB themselves in regard to breast carcinoma diagnosis [Table/Fig-8]. Statistical analysis using Fisher’s exact test between individual diagnostic categories within FNAC and CNB reporting criteria reveals p-value <0.05. So, significant correlation is present between FNAC and CNB in the diagnosis of breast malignancy.

So, on comparative analysis between FNAC and CNB in the diagnosis of breast carcinoma; sensitivity, negative predictive value, diagnostic accuracy were higher in case of CNB than those in case of FNAC. Detection of false negative cases was also lower in CNB assessment. Regarding specificity, positive predictive value, and detection of true negative cases (i.e. which patients really did not have definite malignant lesion); both the procedures turned out to be similar. Both the procedures were shown to have statistically significant correlation with the confirmatory HPE of excision specimens (p-value <0.05). Statistically significant correlation also established between FNAC and CNB among themselves in the diagnosis of breast carcinoma (<0.05).

Excision biopsy is considered to be the gold standard for the diagnosis of breast lump. Emphasis has been placed now-a-days on improving method for establishing a definitive diagnosis of breast mass prior to surgery. Several studies have been conducted to compare the role of FNAC and other histological investigations like Core Needle Biopsy, etc [6,7]. This study reflects the comparability between Fine Needle Aspiration Cytoloy and Core Needle Biopsy in the diagnosis of breast carcinoma considering the histological diagnosis from excision specimen being gold standard. In our study, total 50 patients were included (49 female and 1 male). Age range was 26-75 years (mean = 47.4 years; SD = 10.71). Carcinoma was most commonly diagnosed in the age group of 31-40 years in female patients (31%) followed by in the group of 51-60 years (28.6%). Study by A Khemka et al., expressed that the peak incidence of breast carcinoma was between 40-44 years [6]. Our study is also nearly supportive to it. As per statistics from Breast Cancer India (BCI), the average age of developing a breast cancer has undergone a significant shift over last few decades. An increasing numbers of patients are in the 25 to 40 years of age [8].

As per larger studies on sex-incidence of breast carcinoma, it is an uncommon neoplastic condition in men, accounting for not more than 1% of all breast carcinomas [9]. In our study 2% of the study population were male. This discrepancy is most probably due to selection of lesser number of patients in the study. Of all 50 patients 52% patients had their lesions in the right breast. Right breasts were also slightly more involved in cases of carcinoma (52.4%) than left one. A Aljarrah et al., stated that breast cancer occurs almost equally in the right and left breasts [10]. Among all 50 patients in study, 50% presented with breast lumps in upper outer quadrant of breast followed by central quadrant (14%). Upper outer quadrant was also mostly involved part of the breast by carcinoma in our study (18 patients out of 42 i.e. 42.9%) followed by central quadrant (7 patients i.e. 16.7%) followed by other quadrants of breast. Hussain in his series had 58% of patients in whom upper outer quadrant was involved in breast lumps [11]. As per study done by A Aljajarrah et al., breast carcinoma most commonly affected the upper outer quadrant (UOQ) of the breast [10]. Early breast cancers situated in central/internal quadrants have a worse prognosis compared with those in lateral quadrants, thats why tumour location is an important part in prognosis in terms of distant metastases and survival [12]. In another study, medial location was associated with a 50% excess risk of systemic relapse and breast cancer death compared with lateral location [13,14]. In our study, among 50 patients, size of the lumps ranged from 3 cm to 12 cm. Of all 42 patients having malignancy 27 patients (64.3%) had their breast lesions >5cm of size. The measured size represented by the largest dimension of a mammary carcinoma is one of the most significant prognostic variables. Numerous studies have shown that survival decreases with increasing tumour size and that there is a coincidental rise in the frequency of axillary nodal metastases [9].

Nipple discharge is a less common finding that is most worrisome for carcinoma when it is spontaneous and unilateral. The risk of malignancy in a woman with nipple discharge increases with age; it is associated with carcinoma in 7% of women younger than age 60 but in 30% of older women [15].

HI Vargus et al., and MH Seltzer et al., in their study revealed that nipple discharge is the presenting symptom for 3–9% of patients seen in breast cancer [16,17]. In our study of all 42 patients confirmed for malignancy for breast carcinoma; about 16.7% had discharge from nipple at presentation.

Nipple retraction is an important sign because it may be the first indication of malignancy Invasive cancers tend to become adherent and fixed to the pectoral muscles or deep fascia of the chest wall and the overlying skin, with consequent retraction or dimpling of the skin or nipple.

Involvement of the lymphatic pathways may result in localized lymphoedema. In such cases, the skin becomes thickened around exaggerated hair follicles, giving an appearance known as peau d’orange (“orange peel”). In our study, of all 42 patients confirmed for malignancy; 33.3% show different skin changes at presentation.

Axillary lymph nodes are usually the first anatomic site to be involved by metastases in patients with breast carcinoma. Axillary lymph nodes are often first detected by palpation, either by the patient or physician. The regional lymph node status is the most important prognostic factor in patients with breast cancer and adjuvant therapy protocol after excision of the primary tumour is determined according to lymph node status [18].

Ioachim et al., opined that axillary lymph nodes are palpable in 50% to 60% of patients with clinically detected primary breast carcinomas and the frequency of palpable lymph nodes is much lower in patients in whom the primary breast neoplasms are not detected by physical examination and usually identified by mammography [19]. In our study, of all 42 patients who were for breast carcinoma; about 16.7% had discharge from nipple at presentation. This is slightly higher than other studies which may be due to lower number study patients, patients presenting after long duration of having symptoms, etc.

In our study, of all 42 patients who were suspicious clinically and confirmed for malignancy; 33.3% had palpable axillary lymph node/s at presentation. This discrepancy may be due to selection of lesser number of patients in the study.

Studies carried out by Homesh NA et al., Usami S et al., to compare CNB & FNAC have reported very high sensitivity (91–99%), specificity (96–100%), positive predictive value (100%), and negative predictive value (100%) for CNB which are better than results for FNAC for both palpable and nonpalpable lesions [20,21]. In our study sensitivity and PPP were higher in case of CNB; specificity and NPP were same for both the procedures.

As it is a single institute based study and the study period being very short, the number of case is small. So it is not sufficient to give generalised result to comment on whole population. Survival analysis of breast carcinoma patients cannot be done as follow up was not possible for the short time limit.

FNAC is a rapid, less complicated, economical, reliable and relevant method for the preoperative pathological diagnosis of breast carcinoma in a developing nation like ours. With high sensitivity and specificity, most malignant breast lesions can be reliably diagnosed by FNAC. If the initial FNAC is inadequate, CNB can be a useful second line method of pathological diagnosis in order to minimize the chance of missed diagnosis of breast cancer. One should be mindful of the limitations of each technique and the choice between fine needle aspiration and core biopsy should be individualized for the patient. Excision biopsy should be the last option to obtain a pathological diagnosis.