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EVALUATION OF TRIPLE ASSESSMENT FOR DIAGNOSIS OF BREAST CANCER IN A TERTIARY CENTRE.

BACKGROUND

Breast is a specialised accessory (Modified sweat gland) gland of skin capable of milk secretion.1 Breast diseases may present with lump, nipple discharge or retraction, mastalgia etc. Benign lesion of breast commonly encountered are fibroadenosis, fibroadenoma, cyst, lactational breast abscess, non-lactational breast abscess etc. A malignant breast disease may present as lump in the breast, which is hard and painless (most common). At least tumour should become 1 cm to be clinically palpable. Nipple discharge is the second common presentation. Ulceration and fungation, axillary lymph node enlargement, supraclavicular lymph node enlargement, chest pain and haemoptysis, bone pain, tenderness and pathological fracture, pleural effusion, ascites, liver secondaries, secondary ovarian tumour are other presentations. Pain in the lump occurs in 10% cases. Various risk factors for carcinoma breast have been considered (Table 1). Breast cancer cases have been reported in ancient Egypt and found in Edwin Smith surgical Papyrus from 3000 to 2500 BC. [2,3] Of all the disease of breast the malignant diseases is the most dreaded one, feared not only by the patients but also by the surgeons as well. If a lump is present in the breast, the woman feels threatened. Cancer phobia haunts her. She feels a sense of dissociation. In such cases it is our duty to find out whether the lump is benign or malignant with as much certainty as possible. Triple assessment i.e. clinical assessment--history including (age) and examination; radiological imaging US/ mammography (after 40 years); cytological or historical analysis FNAC/ core biopsypathology. Triple assessment is taken as positive if any of the three components is positive and negative only if all of its components are negative for malignancy.

Aims and Objectives

To evaluate triple assessment for diagnosis of breast cancer in a tertiary centre.

MATERIALS AND METHODS

Study Site

The study was performed in Surgery Department in SGT Medical College, SGT University, Budhera, Gurugram, Haryana, over a period of 2 years 3 months from December 2015 to March 2018.

Study Design

Prospective observational study.

Selection of Subjects (Cases)

A total of 180 patients were studied. Informed consent was taken for physical examination and investigations giving due respect to maintain the patient's privacy and keep them comfortable.

Data Collection

A detailed history about swelling (duration, rate of growth, any rapid growth), any swelling in opposite breast and axilla, details of pain, ulcer if any, nipple discharge, chest pain, cough, haemoptysis, h/o loss of weight, appetite, any pain in abdomen, back and limbs taken. Detailed past family, personal and treatment history taken. Focused clinical examination done. Ultrasonography was performed in supine or oblique position with ipsilateral arm above the head. The breast was scanned in transverse or sagittal or radial and anti-radial planes. USG is the better imaging modality to detect breast lesion in premenopausal women where mammography may not detect small lesion. [4] Ultrasonography can detect the mass as solid or cystic. It is cheap and easily available. There is no radiation. But ultrasonography cannot detect small lesion less than 1 cm in diameter. The sensitivity, specificity, PPV and NPV of USG in detecting carcinoma breast is 55.6%, 97.7%, 83.3% and 91.5% respectively. [5] Irregular margins, irregular internal echoes, irregular posterior shadowing, non-compressibility, ratio between anteroposterior to width (lateral/ horizontal) dimensions more than 1 are features of carcinoma. [6] Mammography was done using craniocaudal and mediolateral views. The sensitivity, specificity, Positive predictive value (PPV) and Negative Predictive value (NPV) of mammography in detecting carcinoma breast is 77.8%, 97.7%, 87.5% and 95.6% respectively. [5] The characteristics of malignant lesion in mammography may be architectural distortion of breast tissue, duct dilation, dense stellate soft tissue mass with irregular margin and spiky projection, microcalcification (in early patients few microcalcification may be normal), stippled calcification, increased thickness of skin due to lymphoedema and nipple retraction may be seen. Fine-needle aspiration cytology was done with 23-gauge needle and 20 mL syringe. The lump was held firmly between fingers and thumb. Needle was passed into lump and with negative pressure continuous aspiration was done until adequate material came out through the needle. Needle with syringe was removed without negative pressure. Material was collected on a slide. Minimum 6 aspirations were done. Smear was prepared using 100% alcohol. Cytology was studied after staining with Giemsa and Papanicolaou stains. FNAC is least painful, can be done on an OPD basis, reliable and cheaper. Malignant deposits will not occur along FNAC track.

Ethical Considerations

The study was started after taking approval from Institutional Ethics Committee for Research on Human Subjects. Throughout the study, ethical considerations were followed strictly. Confidentiality was ensured. The patients were enrolled after written informed consent was obtained from patient and care taken of patient in their local language (mother tongue). Patient and care taker of patient were informed about the nature and purpose of the study. Before entry into the study, the investigator explained to the subjects about the aims and objectives of the study. Patient or caregiver were informed that their participation was voluntary and that they could withdraw consent to participate at any time. They were informed that choosing not to participate would not affect their care and the subjects would receive the proper treatment of his/her disease. The subjects or legally acceptable representative were given sufficient time to read the informed consent form and the opportunity to ask questions. If the subject or relative were unable to read or write informed consent, then investigator read and explained all written information. After this explanation and before entry to the study, consent was appropriately recorded by means of the subject's signature or thumb impression. Subjects who did not give consent to participate were not included in the study. In summary following ethical considerations were observed

1. Before starting the study, approval for this study was obtained from the Institutional Ethics Committee for research on human subjects.

2. Written informed consent was obtained from each subject interviewed after asking them to go through the subject information sheet printed in Hindi language (in which subjects were well versed) and a verbal explanation by the interviewer.

3. Confidentiality of the information provided was maintained.

Statistical Methods in Methodology

The data were collected, and entries were made, and analysis was carried out using statistical SPSS version 23 software. Analysis was studied using Chi-square test. Sensitivity, specificity, NPV and PPV were also carried out in each category of the assessment criteria like clinical assessment, ultrasonography, mammography and FNAC. Sensitivity is considered as proportion of persons with the diseases who test positive in the screen. Specificity is the proportion of persons who do not have the disease that test negative in the screening test. The PPV is the proportion of persons who test positive that actually have the diseases. NPV is the proportion testing negative that do not have the disease. Statistically significant p-value of less than 0.05 was considered statistically significant. P-value less than 0.01 was considered as statistically very significant and p-value of less than 0.001 was considered as statistically extremely significant.

RESULTS

The study was performed in Surgery Department in SGT Medical College, SGT University, Budhera, Gurugram, Haryana, over a period of 2 years 3 months from December 2015 to March 2018. A total of 180 patients were studied. A detailed history was taken, focused clinical examination done, USG, mammography and FNAC were performed. The results were evaluated. Our maximum patients were in the age group of 30 to 39 followed by age group 20 to 29. Constituting 41.0% and 24.3% respectively (Table 2). 80% patients were from rural area and 20% from urban area (Table 2). One hundred and sixty one (88.9%) were premenopausal and 19 (10.1%) were postmenopausal (Table 3). Out of total patients 126 (70%) were married and 54 (30%) were unmarried (Table 3). Breast swelling was most common presenting feature in 173 (96.0%) patients. Swelling and pain was in 5(2.8%) patients. Swelling and retraction was in 1 (0.6%) patient. Retracted nipple was found in 2 (1.1%) patients. Nipple discharge was there in 2 (1.1%) patients. Erythema of skin was in 3 (1.7%) patients. Puckering was present in 2(1.1%) patients. Palpable axillary lymph nodes were present in 5 (2.8%) patients. There was family history of carcinoma breast in 4 (2.1%) patients (Table 4). Right side breast was involved in maximum patients (106 patients, 58.9%) (Table 5). Upper and outer quadrant was most commonly involved (86 patients, 48.0%) (Table 5). All the patients underwent ultrasonography. Fibroadenoma was present in maximum patients (116 patients, 64.4%). Fibroadenosis was in 29 patients, galactocele 2 patients, breast abscess 20 patients, lactation changes in 1 patient and cyst was present in 2 patients. Solid mass finding was in 5 (2.8%) patients. Solid mass with irregular margin were present in 4 (2.2%) patients. Loss of normal architecture were found in 1 (0.6%) patient (Table 6). Mammography done only in married patients revealed well-circumscribed mass with regular margins in 113 (90.0%) patients. Density lesion with microcalcification was found in 3 (2.3%) patients. Density with irregular margins and speculation was found in 7 (5.4%) patients. Density lesion with microcalcification, irregular margins and spiculation was found in 3 (2.3%) patients (Table 7). FNAC was done in all patients. Fibroadenoma was found in maximum number of patients (114, 63.2%). Duct carcinoma was found in 11 (6.1%) patients (Table 8). On histopathology fibroadenoma was found in 108 (72.0%) patients, fibroadenosis was found in 5 (3.3%) patients, breast abscess was found in 21 (14.0%) patients, inflammatory changes was found in 1 (0.7%) patient and infiltrating ductal carcinoma of breast were found in 15 (10.0%) patients (Table 9). There was a concordance of 97.3%, PPV of 80%, NPV of 99.3%, 92.3% sensitivity and 97.8% specificity on physical examination. There was a significant P-value of 0.0000. In case of mammography corresponding values were 98.1%, 86.7%, 100%, 97.9% and 100% respectively for concordance, PPV, NPV, sensitivity and specificity respectively. Again, there was a significant p-value (0.000). So far as USG is concerned the values were 96.7%, 66.7%, 100%, 100% and 97.1% respectively for concordance, PPV, NPV, sensitivity and specificity respectively. There was again a significant p-value of 0.000. On FNAC, the results were like this. Concordance 97.3%, PPV 73.3%, NPV 100%, sensitivity 100% and specificity 97.1% with a significant p-value of 0.000. The results of all the above modalities were on comparison with histopathology examination. The final results for triple assessment were like this. Concordance 99.3%, PPV 93.3%, NPV 100%, sensitivity 100% and specificity 99.3% and a significant p-value of 0.000%.

DISCUSSION

This study of evaluation of triple assessment for diagnosis of breast cancer in a tertiary centre was performed in Surgery Department in SGT Medical College, SGT University, Budhera, Gurugram, Haryana, over a period of 2 years 3 months from December 2015 to March 2018. A total of 180 patients were studied. A combination of three tests (Triple assessment) i.e. clinical assessment--history including (age) and examination; radiological imaging US/ mammography (after 40 years); cytological or historical analysis FNAC/ core biopsypathology. Triple assessment is taken as positive if any of the three components is positive and negative only if all of its components are negative for malignancy.

As per physical examination, malignant disease was in favour of 13 patients. Histopathology revealed malignancy in 12 patients. Benign disease was considered in 137 patients on physical examination. On histopathology, benign disease was confirmed in 134 patients and the remaining 3 patients diagnosed as malignant (Table 10). Our results were similar to Yang et al (1996).7 The results of mammography revealed positive predictive value of 86.7% and negative predictive value of 100% with significant p-value of 0.000. The results are comparable with Shetty et al (2003).8 Marteli et al (1990) [9] also gave similar results. Kaufman et al (1994)10 found the sensitivity of mammography as 89.0% and specificity as 73.0%. The results of Steinberg et al (1996)11 and Yang et al (1996) [7] were also similar. Ultrasonography was in favour of malignancy in 10 patients, who were all found to be malignant on histopathology. On ultrasonography 140 cases were diagnosed as benign, of which 5 were malignant on histopathology. Thus, the sensitivity was 100%, specificity was 96.4%, positive predictive value was 66.7% and negative predictive value was 100%. 'P' value was significant (0.000). Our results were comparable to Pande et al (2003) [12] and Yang et al (1996). [6]

In 11 patients, FNAC revealed malignancy. All these patients were malignant as per histopathology also; however, 4 patients who were told benign by FNAC were actually found to be malignant as per histopathology. Sensitivity of FNAC was 100%, specificity was 97.1%, positive predictive value was 86.7% and negative predictive value was 100%. 'P' value was significant (0.000). Our results of FNAC were similar to Marteli et al (1990), [9] Kaufman et al (1994), [10] Steinberg et al (1996), [11] Reinikainen et al (1990p and Ariga et al (2002). [14] The results of Mohammad et al (2005) [15] of FNAC were 100% for positive predictive value, 90.6% for sensitivity and 100% for specificity. Thus, we have in triple assessment the concordance of 99.3%, specificity of 100%, sensitivity of 99.3%, positive predictive value of 99.3%, negative predictive value of 100% and a significant p-value (0.000).

CONCLUSION

We have found that in diagnosis of breast cancer in our tertiary centre, the triple assessment was found to be very useful in evaluating patients of breast lumps with an overall accuracy of 99.3%. When clinical examination, mammography, USG and FNAC are all negative for malignancy in a patient with breast lump, the patient is unlikely to have malignancy and need for histology can be obviated and patient can be safely observed.

ACKNOWLEDGEMENTS

I would like to acknowledge the books, Farquharson's Textbook of Operative General Surgery, 9th Edition, Margaret Farquharson; SRB's Manual of Surgery 5th Edition by Sriram Bhat M; Bedside Clinics in Surgery, 3rd Edition by Makhan Lal Saha.

REFERENCES

[1] Farquharson M, Hollingshead J, Moran B. Farquharson's Textbook of operative general surgery. 9th edn. London: CRC Press 2005.

[2] Bland KI, Beenken S, Copeland EM III. The breast. Schwartz's Princip Surg. 2005;16:454.

[3] Iglehart JD, Kaelin CM. Diseases of the breast. In: Sabiston Text book of surgery. Vo. 1. 17th edn. 2004: p. 877.

[4] Saha ML. Bedside clinical in surgery. 3rd edn. New Delhi: Jaypee Brothers Medical Publishers 2018.

[5] Tiwari PK, Ghosh S, Agrawal VK. Diagnostic accuracy of mammography and ultrasonography in assessment of breast cancer. International Journal of Contemporary Medical Research 2017;4(1):81-3.

[6] Bhat SM. SRB's Manual of surgery. 5th edn. New Delhi: Jaypee Brothers Medical Publishers 2016.

[7] Yang WT, Mok CO, King W, et al. Role of high frequency ultrasonography in the evaluation of palpable breast masses in Chinese women: alternative to mammography? J Ultrasound Med 1996;15(9):63744.

[8] Shetty MK, Shah YP, Sharman RS. Prospective evaluation of the value of combined mammographic and Sonographic assessment in patients with palpable abnormalities of the breast. J Ultrasound Med 2003;22(3):263-8.

[9] Martelli G, Pilotti S, Coopmans de Yoldi CG, et al. Diagnostic efficacy of physical examination, mammography, fine needle aspiration cytology (triple-test) in solid breast lumps: an analysis of 1,708 consecutive cases. Tumouri 1990;76(5):476-9.

[10] Kaufman Z, Shpitz B, Shapiro M, et al. Triple approach in the diagnosis of dominant breast masses: combined physical examination, mammography and fine-needle aspiration. J Surg Oncol 1994;56(4):254-7.

[11] Steinberg JL, Trudeau ME, Ryder DE, et al. Combined fine-needle aspiration, physical examination and mammography in the diagnosis of palpable breast masses: their relation to outcome for women with primary breast cancer. Can J Surg 1996;39(4):302-11.

[12] Pande AR, Lohani B, Sayami P, et al. Predictive value of ultrasonography in the diagnosis of palpable breast lump. Kathmandu Univ Med J (KUMJ) 2003;1(2):7884.

[13] Reinikainen HT, Rissanen TJ, Piippo UK, et al. Contribution of ultrasonography and fine-needle aspiration cytology to the differential diagnosis of palpable solid breast lesions. Acta Radiol 1999;40(4):383-9.

[14] Ariga R, Bloom K, Reddy VB, et al. Fine-needle aspiration of clinically suspicious palpable breast masses with histopathologic correlation. Am J Surg 2002;184(5):410-13.

[15] Mohammed AZ, Edino ST, Ochicha O, et al. Value of fine needle aspiration biopsy in preoperative diagnosis of palpable breast lumps. Ann Afric Medi 2005;4(1):1922.

Kanwar Singh Goel (1), Sapna Goel (2)

(1) Associate Professor, Department of General Surgery, SGT Medical College, SGT University, Budhera, Gurugram, Haryana.

(2) Senior Resident, Department of Pathology, SHKM Government Medical College, Nalhar, Mewat, Haryana.

'Financial or Other Competing Interest': None.

Submission 09-04-2018, Peer Review 05-05-2018, Acceptance 12-05-2018, Published 21-05-2018.

Corresponding Author: Dr. Sapna Goel, Department of Pathology, 25/6, Opp. Bal Bhawan, Gandhi Nagar, Scheme No. 6, Jind.

E-mail: kanwarsinghgoel@rediffmail.com

DOI: 10.14260/jemds/2018/580
Table 1. Showing Risk Factors Classification

Slight-to-Moderate     Moderate-to-High     Very High Risk
Risk                   Risk

Florid hyperplasia     Age > 60 years       Therapeutic
                                            radiation

Solid duct papilloma   LCIS                 Family history of
                                            breast cancer in two
                                            1st degree relatives

Obesity, alcohol,      History of DCIS      Family history of
HRT                                         breast and ovarian
                                            cancer

Nulliparity            Cancer on one side   Mutation of tumour
                       breast               suppressor genes
                                            BRCA1/BRCA2

Early menarche, late
menopause

Table 2. Showing Age and Demographic Distribution of the Study Cases
(No. of Patients-180)

Age (Year)   No. of Patients   Percentage

<20          15                8.1
20-29        44                24.3
30-39        73                41.0
40-49        30                16.6
>50          18                10.0
Rural        135               80.0
Urban        45                20.0

Table 3. Showing Menstrual Profile and Marital Status of Patient

Age (Year) of                      No. of     Percentage
Menarche                           Patients

Menstruation     Pre-menopausal    161        88.9
status           Post-menopausal   19         10.1

Marital status   Married           126        70.0
                 Unmarried         54         30.0

Table 4. Showing Clinical Feature of Patients (No. of Patients= 180)

Clinical Feature                    No. of Patients   Percentage

Presence of lump                    173               96.0
Lump along with retraction          5                 2.8
Lump with pain                      1                 0.6
Retraction of nipple                2                 1.1
Presence of discharge from nipple   2                 1.1
Erythema of skin                    3                 1.7
Presence of puckering               2                 1.1
Presence of axillary lymph nodes    5                 2.8
Presence of history of carcinoma    4                 2.1
breast in family

Table 5. Showing Side and Quadrants of the Affected Breast in the
Studied Patients

Characteristics               No. of Patients   Percentage

Side involved   Left          72                40.0
                Right         106               58.9
                Bilateral     2                 1.1

Quadrant        Central       19                10.6
                Upper outer   86                48.0
                Upper inner   33                18.0
                Lower outer   21                11.2
                Lower inner   21                11.2

Table 6. Showing Ultrasonographic Impression of the Breast Lumps in
the Patients (No. of Patients= 180)

USG Impression                      No. of Patients   Percentage

Fibroadenoma                        116               64.4
Fibroadenosis                       29                16.0
Galactocele                         2                 1.1
Breast abscess                      20                11.2
Lactational changes                 1                 0.6
Solid mass                          5                 2.8
Solid mass with irregular margins   4                 2.2
Loss of normal architecture         1                 0.6
Cyst                                2                 1.1
Total                               180               100

Table 7. Showing Mammographic Findings in Patients

Findings                                  No. of Patients   Percentage

Well circumscribed mass with regular      135               91.3
margins
Density lesion with microcalcification    3                 2.0
Density lesion with irregular margins     7                 4.7
and spiculation
Density lesion with microcalcification,   3                 2.0
irregular margins and spiculation
Total                                     148               100

Table 8. Showing Results of FNAC in the Studied Patients

FNAC               No. of Patients   Percentage

Fibroadenoma       114               63.2
Fibroadenosis      30                16.6
Galactocele        2                 1.1
Breast abscess     23                13.0
Ductal carcinoma   11                6.1
Total              180               100

Table 9. Showing Results of Histopathology in the Studied Patients
(No. of Patients= 150)

Findings                                  No. of Patients   Percentage

Fibroadenoma                              108               72.0
Fibroadenosis                             5                 3.3
Breast abscess                            21                14.0
Infiltrating ductal carcinoma of breast   15                10.0
Inflammatory changes                      1                 0.7

Table 10. Showing Results of Physical Examinations in Triple
Assessment

Modality of Triple            Histopathology          No. of
Assessment                    Malignant    Benign     Patients

Physical      Malignant (+)   12 (92.3%)   1 (7.7%)   13
examination   Benign (-)      3 (2.2%)     134        137
Total                         15           135        150

Modality of Triple            Positive     Negative
Assessment                    Predictive   Predictive
                              Value        Value

Physical      Malignant (+)   80%          99.3%
examination   Benign (-)
Total

Table 11. Showing Results of Mammography in Triple Assessment

Modality of Triple        Histopathology          No. of
Assessment                Malignant   Benign      Patients

Mammography   Malignant   13 (100%)   0           13
              Benign      2 (2.1%)    92 (97.9)   94
Total                     15          92          107

Modality of Triple        Positive     Negative
Assessment                Predictive   Predictive
                          Value        Value

Mammography   Malignant   86.7%        100%
              Benign
Total

Table 12. Showing Results of USG in Triple Assessment

Modality of Triple   Histopathology           No. of
Assessment           Malignant   Benign       Patients

USG     Malignant    10 (100%)   0            10
        Benign       5 (3.6%)    135 (96.4)   140
Total                15          135          150

Modality of Triple   Positive     Negative
Assessment           Predictive   Predictive
                     Value        Value

USG     Malignant    66.7%        100%
        Benign
Total

Table 13. Showing Results of FNAC in Triple Assessment

Modality of Triple   Histopathology           No. of Patients
Assessment           Malignant   Benign

FNAC    Malignant    11 (100%)   0            11
        Benign       4 (2.9%)    135 (97.1)   139
Total                15          135          150

Modality of Triple   Positive     Negative
Assessment           Predictive   Predictive
                     Value        Value

FNAC    Malignant    73.3%        100%
        Benign
Total
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Title Annotation:Original Research Article
Author:Goel, Kanwar Singh; Goel, Sapna
Publication:Journal of Evolution of Medical and Dental Sciences
Article Type:Report
Geographic Code:9INDI
Date:May 21, 2018
Words:3593
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