A palpable Lump or Mass is the commonest mode of presentation of various diseases of the breast and preoperative evaluation remains always essential as a part of their management.^[1],^[2]This preoperative evaluation or assessment includes combination of clinical assessment, radiological imaging and a tissue sample taken for either cytological or histological analysis, the so-called triple assessment.^[3]         As a part of this triple assessment, Fine Needle Aspiration Cytology (FNAC) remains always useful and beneficiary for the patients because of a lot of advantages like high accuracy, cheap, fast, out-patient procedure reducing pressure on theatre load, high acceptability, and low complication rate.^[4]

According to FNAC reports, breast lumps or masses can be classified into 5 categories based on the National Health Services Breast Screening Programme (NHSB­SP) of Britain^[5] Such classification becomes helpful in further management of the patient and the diagnostic categories with their corresponding numerical codes are: Inadequate/insufficient (C1); Benign (C2); Atypical/indeterminate (C3); Suspicious of malignancy (C4) and Malignant (C5). The aim of our present study is evaluation of the accuracy and effectiveness of this FNAC based categorization or classification of breast lumps in our institute.

Material and Methods

The present retrospective study was conducted at Department of Pathology, GMERS Medical College & Hospital, Junagadh, Gujarat, India. Duration of the study was two years from January 2017 to December 2018. For statistical analysis, data was collected from cytology & histopathology laboratory registers with some inclusion & exclusion criteria mentioned below:

Inclusion criteria:

1. All female patients of different age groups who presented with a palpable breast lump or mass but with unknown primary diagnosis
2. Patients who underwent both FNAC at OPD basis & subsequent post-operative histopathological evaluation.

Exclusion criteria:

1. Patients who underwent FNAC but did not undergo subsequent histopathological diagnosis.
2. Patients with recurrent malignancy.
3. Patients with history of past or current chemotherapy or any other forms of treatment.
4. Male patients with benign or malignant breast lesions.

Data was evaluated in terms of sensitivity, specificity, positive & negative predictive values, false positive rate, false negative rate and overall diagnostic accuracy. Results were presented in frequency tables & cross tabulations. For statistical evaluation, we utilized the Statistical Package for Social Sciences (SPSS) version 17.0. (SPSS Inc. Released in 2008; SPSS Statistics for Windows, Ver­sion 17.0. Chicago, USA).For statistical significance, we utilized the Chi-square (?^[2]) test ^[6] and the Kappa Statistics^[7] both.

Result

During last two years (2017 & 2018), a total number of 600 patients were undergone the procedure of FNAC for various lesions & out of them, 215 patients were females who presented with a palpable lump or mass in the breast but having no known primary diagnosis. Left sided lumps or lesions were more common or more in number (60.00%) than right sided ones (40.00%). The commonest location was upper & outer quadrant of breast (49.30%) & next common location was sub-areolar region of breast (16.28%). Less common locations were upper & inner quadrant (16.28%), lower & outer quadrant (11.16%) as well as lower & inner quadrant (6.98%) respectively.

Out of 215 cases, only 145 were undergone subsequent post-operative histopathological evaluation, so we included only these cases for further statistical analysis & evaluation. A total number of 70 patients defaulted from post-operative evaluation because of one reason or another so default rate was 32.56%. Out of 145 cases, 31 were unequivocally malignant (C5) while 78 were benign (C2) i.e. negative for malignant cells. Five cases were benign lesions but having nuclear atypia (C3) while eight cases were suspicious for malignancy (C4). Total 23 FNAC smears were unsatisfactory or inadequate for evaluation (C1) giving unsatisfactory rate of 15.85%.

Age wise distribution of 215 patients, comparative evaluation of cytology reports (categories) of 145 patients and diagnostic validities of FNAC procedure & reports after exclusion of unsatisfactory, atypical & suspicious smears are mentioned below in table no. 1, 2 and 3 respectively.

Table 1: Age wise distribution of patients or cases presented with breast masses (n=215)

Table 2: Comparative evaluation of cytology reports (categories) of patients with their subsequent histopathological diagnosis (n=145)

Table 3: Diagnostic validities of FNAC* procedure & reports after exclusion of unsatisfactory, atypical & suspicious smears (n=109)

Discussion

In our present study, we included women of all age groups who presented with breast lumps or masses but having no any previous diagnosis. Benign lesions were commonly found among women belonging to age groups of 21-30 years and 31-40 years. Suspicious or Confirmed cases of malignancy were commonly found among age groups of 41-50 years and 51-60 years. Similar results were obtained in other studies like those done by Veena Kumari L et al.^[2] Left sided breast lesions (60%) were more common than right sided ones (40%) and upper & outer quadrant was the commonest location (49.30% cases). In a similar study done by Kosthi A et al,^[8] left sided breast lesions were found in 50.66% cases while right sided lesions were found in 40.87% cases. Rests of 8.47% cases were presented as bilateral lesions. Upper & outer quadrant was the commonest location (56.88% cases). Among other similar studies like those done by Waghmare RS et al,^[9] by Zuk JA et al^[10] and by Rocha PD et al,^[11] upper & outer quadrant was the commonest topographical location for breast lumps and results were 42.54%, 42.20% & 45.20% respectively. So it is now obvious that age-wise distribution, site & topographical location of various breast lesions (both benign & malignant) remain more or less similar everywhere.

In this study, majority of the cases belong to C2 or benign category (53.78%) followed by those belonging to C5 or malignant category (21.37%). Study done by Veena Kumari L et al^[2] shows 75.28% cases & 11.20% cases belonging to C2 and C5 categories respectively. In a similar study done by Madubogwu CI et al,^[4] 41.8% of cases belong to C2 category and 34.6% cases belong to C5 category respectively. Studies done by Kosthi A et al^[8] and Waghmare RS et al^[9] also show similar outcomes. Atypical (C3) and suspicious (C4) categories are rare everywhere. In other words, we can say that most of the cases of breast masses are further classified into two groups only, either benign (C2) or malignant (C5). The commonest category is C2 and next common category is C5.

Statistical analysis of our present study was compared with that of other similar studies and the comparative evaluation is mentioned below in table no. 4.

Table 4: Comparative evaluation of statistical analysis of various studies