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www.jmscr.igmpublication.org Impact Factor 5.84 Index Copernicus Value: 83.27 ISSN (e)-2347-176x ISSN (p) 2455-0450 DOI: https://dx.doi.org/10.18535/jmscr/v5i4.57 Efficacy of Mammography in Detecting Breast Masses Using Histopathology as Gold Standard Authors Dr Niya Ann Kurien 1, Dr Viji Krishnan 2 1 Assistant Professor, Department of Radiodiagnosis, MOSC Medical College, Kolenchery, Kerala 2 Associate Professor, Department of Biochemistry, JMMC & RI, Thrissur, Kerala Corresponding Author Dr Viji Krishnan Associate Professor, Department of Biochemistry, JMMC & RI, Thrissur, Kerala Email: vijikrishnandr@yahoo.in Abstract Background: Early detection is an essential step in decreasing the morbidity and mortality of breast cancer. Mammography is a proven effective tool for early breast cancer detection. The aim and objective of this study is to assess the efficacy of mammography in the evaluation of breast masses based on the Breast Imaging Reporting and Data System (BI-RADS) for differentiating between benign and malignant breast lesions keeping histopathology as gold standard Materials and Methods: The present study is an analytical study of patients presenting with breast masses, with age group ranging between 31 to 89 years referred to the department of radio-diagnosis Findings of mammogram along with BI-RADS category were correlated with histopathological findings, keeping it as gold standard. Results: Based on the BI-RADS 50 study cases were categorized and confirmed with histopathology, keeping it as gold standard. The diagnostic accuracy of BI-RADS IV &BI-RADS V was 96% and88 % and was found to be very high.the kappa value also shows statistical significance which were 0.92 and 0.75 respectively for BIRADS V and BIRADS IV and V. Conclusion: This study proves the diagnostic accuracy of mammography as a method of choice to evaluate breast masses keeping histopathology as gold standard. Keywords: Breast masses, Mammography, histopathology. Introduction Correct diagnosis is a prerequisite for successful cancer treatment. The diagnosis of breast cancer relies on a combination of clinical examinations, histopathology, and imaging studies that provide the clinician with relevant prognostic and predictive information to counsel patients and initiate cancer treatment. The earlier it is diagnosed the better the survival rates [1]. Breast tissue is subjected to a great magnitude of hormones with cyclical changes and this renders it susceptible to diseases in females of all ages [2]. Palpable breast lump are the second most common presentation of breast disease in various studies, commonest being breast pain [3,4]. Breast screening by mammography has increased awareness of breast cancer, which is the second Dr Niya Ann Kurien et al JMSCR Volume 05 Issue 04 April 2017 Page 20080

most common cause of death in females which necessitates an urgent need to differentiate benign from malignant tumours [5]. The National Comprehensive Cancer Network (NCCN), in the most recent Clinical Practice Guidelines, has recommended percutaneous breast biopsy for lesions categorised as Breast Imaging Reporting and Data System (BI-RADS) [6-10]. Studies investigating the positive predictive value (PPV) of mammographic features described in the mammography BI-RADS lexicon have found it to be useful in differentiating between benign and malignant breast lesions [11,12]. Despite several positive reports on the mammographic distinction between benign and malignant breast lesion [13-15], laboratory confirmation of the breast lesion by histopathology is widely held as the gold standard. Histopathology involves an invasive technique of biopsy for both benign and malignant cases. The aim and objective of this study is to assess the efficacy of mammography in the evaluation of breast masses basedon the Breast Imaging Reporting and Data System (BI-RADS) for differentiating between benign and malignant breast lesions keeping histopathology as gold standard. The resultant diagnosis finally leads to early and appropriate patient care and subsequent neo adjuvant and surgical treatment in case of malignancy. Materials and Methods Ethical Approval: Institutional Ethical Committee clearance was obtained In addition, informed consent was obtained from all the patients prior to mammography. Inclusion Criteria: All female patients suspected or clinically diagnosed breast masses based on mammographic findings above 30 years (age group ranging from 31-89 years) Exclusion Criteria: All female patients with cystic breast lesions based on mammographic findings and below 30 years of age. This comprised of 50 patients presented with lumps of the breast patients referred for mammography and concurrent histology assessment within the period of the study, who met the inclusion criteria. The equipment usedwas dedicated mammography unit METALTRONICA. According to BI-RADS lexicon mammograms fall into six categories BI-RADS scale Interpretation 0 Inconclusive I Negative II Benign finding III Probably benign IV Suspicious finding V Highly suggestive of malignancy finding VI Proven malignancy No one with BI-RADS score of 0, I, and II was there in the study. For those with BI-RADS-IV and BI-RADS-V lesions biopsies were undertaken, whereas for those with BI-RADS-III lesions, the clinician recommended those patients with a family history for biopsy. A cut off of BIRAD IV or above was considered as positive case of breast cancer, which was confirmed by histopathology. Statistical software namely SPSS version 18was used for the analysis of data.the study outcome was measured in terms of diagnostic accuracy of mammography using BI- RADS in detecting breast cancer keeping histopathology as gold standard. The sensitivity, specificity, PPV (Positive predictive value) and NPV (Negative predictive value) were measured according to the standard formulae for calculating diagnostic accuracy parameters. Results In this study the age of the patients were between 31 to 89 years, the mean age being 50 years. The maximum number of lesions was seen in the age group < 50 years and 23 patients were > 50 years (46 % as in Table I Table I, I- Percentage distribution of the sample according to age Age Count % <50 27 54.0 >=50 23 46.0 Mean ±SD 50 ± 11.2 Dr Niya Ann Kurien et al JMSCR Volume 05 Issue 04 April 2017 Page 20081

Percentage Percentage JMSCR Vol 05 Issue 04 Page 20080-20084 April 2017 I From table I it can be seen that out of 29 malignant cases, 14(51.9 %) were aged less than 50years and 15(65.2%) were >50years.Altogether, there were 21 benign cases out of which 13(48.1%) of them were aged less than 50 years and 8(34.8%) were > 50 years. The Chi-square test gives a value of 0.91 and p value of 0.340 which is not significant. So the present study shows no significant association between age and pathological finding. Out of the 50 mammograms there was no one with BI-RADS score of 0, I, and II. 17 (34%) were categorized under BI-RADS-III, 6 (12%) were BI- RADS-IV, 27(54%) were BI-RADS-V and none of the patients in BI-RADS-VI. There were 27 malignant cases and 23 benign cases (Table II) Table II, II- Comparison of BI-RADS category keeping histopathology as gold standard BI-RADS category 7 6 5 4 3 2 1 51.9 48.1 65.2 <50 >=50 Malignant Benign 34.8 Malignant Benign Count % Count % BI-RADS III 1 5.9 16 94.1 BI-RADS IV 1 16.7 5 83.3 BI-RADS V 27 100 0 II 10 94.1 83.3 10 (83.3%)were benign. All 27(100 %) BIRADS V masses were malignant. In the study, the individual sensitivity (Table III, III) and specificity of BIRADS V (99.1% and 100%) BIRADS IV&V (96.6%&76.2%). Similarly the positive predictive value was 100 %& 84.8% and negative predictive value was 91.3% & 94.1% respectively. The diagnostic accuracy was 96% and88 % and was found to be very high. The above table (table III) shows that BIRAD category in predicting malignancy if pathology finding is gold standard is significant from kappa value which were 0.92 and 0.75 respectively for BIRADS V and BIRADS IV and V which is consistent with other studies [7,8]. Table III, III-BI-RADS category in predicting malignancy if histopathology as gold standard BI-RADS V BI-RADS IV& V Sensitivity 93.1 96.6 Specificity 10 76.2 False Negative 6.9 3.4 False Positive 23.8 Predictive value of positive test 10 84.8 Predictive value of negative test 91.3 94.1 Positive likelihood ratio - 4.1 Negative likelihood 0.1 ratio Accuracy 96.0 88.0 Kappa 0.92** 0.75** **:-Significant at 1 level III 8 6 4 2 5.9 16.7 3 4 5 Malignant Benign The table II indicates that 1 (5.9%) out of 17 BIRADS III masses was malignant and 16 (94.1%) were benign and 1(16.7%)out of 6 BIRADS IV masses were malignant and 5 Dr Niya Ann Kurien et al JMSCR Volume 05 Issue 04 April 2017 Page 20082

Discussion The goal of screening mammogram is to discover breast lesions at its pre-cancerous Stage. Mammography is an easy to perform, low cost technique by which breast cancer can be detected. For early detection of breast cancer, it is the modality of choice as it is the only evidence based early detection method [16]. The BI-RADS lexicon was first developed in 1993 for reporting mammography. Since its establishment, several studies have found that it can be helpful to physicians in predicting the likelihood of cancer [11,12,17]. The current study found out a very high sensitivity of BI-RADS V & BI-RADS IV &V (93 %& 96.6%) and specificity (100 %& 76.2%) of BIRADS respectively, in the diagnosis of breast cancer. Many previous investigators also highlighted the importance of BIRADS with high accuracy in terms of sensitivity and specificity of the test [18]. The comparison of BI-RADS categories with histological results was well in line with the results of some studies using mammography [19]. This comparable evidence by previous investingators highlights the importance of BIRADS mammography in the detection of breast cancer. Whilst the incidence of breast cancer is higher in high income countries, mortality due to breast cancer is higher in low and middle income countries due to lack of timely detection and treatment. The American College of Radiology has recently released an updated edition of BI- RADS which includes mammographic illustrations of breast findings [20]. This teaching devise may improve understanding of radiologists to improve their skills about BI-RADS terms and also warrants testing so that the variability in mammographic interpretation can be decreased. Conclusion The results of our study show a very high agreement with the likelihood of malignancy after BI-RADS categorization for mammogram. So based on the study results it is concluded that that the diagnostic accuracy of mammography is a method of choice to evaluate breast masses is very good keeping histopathology as gold standard. Acknowledgements This research was conducted as a part of dissertation at Jubilee Mission Medical College & Research Institute (JMMC&RI), Thrissur, Kerala. The author thanks Dr.M.R. Balachandran Nair, Head of the Department of Radio diagnosis (JMMC &RI) and other colleagues from JMMC& RI for their valuable suggestions. The author also wants to thank the patients for their cooperation without which this work would not have been completed. Source of support: Funded by the institution References 1. Ascunce N, del Moral A, Murillo A, Alfaro C, Apesteguia L, Ros J, Abascal L, Aizcorbe M, Dominguez F. Early detection programme for breast cancer in Navarra, Spain. Eur J Cancer 1994; 3 Suppl 1:41-8. 2. Ghumro AA, Khaskheli NM, Memon AA, AnsariAG, Awan MS. Clinical profile of patients with breast cancer. J Coll Physician Surg Pak 2002; 12: 28-31. 7. 3. Ohene-Yeboah M, Amaning EP. Spectrum of complaints presented at a specialist breast clinic in kumasi, Ghana. Ghana Medical Journal Sep.2008; 42(3): 110-112. 4. Abhijit M, Anantharaman, Bhoopal S, Ramanujam R. Benign breast diseases: experience at a teaching hospital in rural India. International Journal of Research in Medical Sciences 2008; 1(2): 73-78. 5. Sufian SN, Masroor I, Mirza W, Butt S, Afzal S, Sajjad Z. Evaluation of common risk factors for breast carcinoma in females: a hospital based study in Karachi, Pakistan. Asian Pac J Cancer Prev2015; 16:6347-52. Dr Niya Ann Kurien et al JMSCR Volume 05 Issue 04 April 2017 Page 20083

6. Franceschi D et al. Global Summit Early Detection and Access to Care Panel. Breast Cancer in Limited-Resource Countries: Early Detection and Access to Care. Breast J 2006; 12: S16 S26. 7. KopansDB. Standardized mammographic reporting. Radiol Clin North Am 1992; 30: 257 261. 8. 8.D'Orsi CJ, Kopans DB. Mammographic feature analysis. Semin Roentgenol 1993; 28: 204 230. 9. 9.American College of Radiology. BI- RADS: mammography. In Breast Imaging Reporting and Data System: BI-RADS Atlas (4 th edn). American College of Radiology: Reston, VA, 2003. 10. NCCN Clinical practice guidelines in oncology. Breast cancer screening and diagnosis 2012. 11. Liberman L, Abramson AF, Squires FB, Glassman JR, Morris EA, Dershaw DD. The Breast Imaging Reporting and Data System: positive predictive value of mammographic features and final assessment categories. AJR Am J Roentgenol 1998; 171: 35 40. 12. Bérubé M, Curpen B, Ugolini P, Lalonde L, Ouimet-Oliva D. Level of suspicion of a mammographic lesion: use of features defined by BI-RADS lexicon and correlation with large-core breast biopsy. Can Assoc Radiol J1998; 49: 223 228. 13. Harper, P.A., E. Kelly-Fry, J.S. Noe, R.J. Bies and V.P. Jackson, 1983. Ultrasound in the evaluation of solid breast masses.radiology, 146: 731-736. 14. 14. Stavros, A.T., D. Thickman, C.L. Rapp, M.A. Dennis,S.H. Parker and G.A. Sisney, 1995. Solid breast nodules: Use of sonography to distinguish between benign and malignant lesions. Radiology, 196: 123-134. 15. Hong, A.S., E.L. Rosen, M.S. Soo and J.A. Baker, 2005. BI-RADS for sonography: Positive and negative predictive values of sonographic features, 184: 1260-1265. 16. Smith RA, Caleffi M, Albert US, Chen THH, Duffy SW, Franceschi D et al. Global Summit Early Detection and Access to Care Panel. Breast Cancer in Limited-Resource Countries: Early Detection and Access to Care. Breast J 2006; 12: S16 S26. 17. Baker JA, Kornguth PJ, Lo JY, Floyd CE. Breast cancer: prediction with artificial neural network based on BI- RADS standardized lexicon. Radiology 1995;196: 817 822. 18. Chan KKK, Lui CY, Chu T, Chan KK, Yan AT, Wong K et al. Stratifying Risk for malignancy Using Microcalcification Descriptors from the Breast Imaging Reporting and Data System 4th Edition: Experience in a single Center in Hong Kong. J HK CollRadiol.2009; 11:149-53. 19. Orel SG, Kay N, Reynolds C, Sullivan DC. BI-RADS categorization as a predictor of malignancy. Radiology 1999; 211: 845 850. 20. World Health Organization. Cancer Fact sheet No 297, February 2011. Geneva: WHO;2011. Dr Niya Ann Kurien et al JMSCR Volume 05 Issue 04 April 2017 Page 20084