Clinical Correlation Of Selected Biomarkers Of Breast Cancer With Disease Profile And Treatment Outcome: A Prospective Study From A Single Institute.

Introduction: Bio markers used for guiding treatment protocols and prognostication in breast cancer are unique from other solid tumours. This is because breast cancer is biologically a heterogenic disease and staging alone is insufficient for treatment decision making. Pathological markers like hormone receptors, growth factor receptors and new molecular genomic markers or gene signatures are increasingly used as predictive markers for adjuvant therapy. However, many of these tests are yet to be validated or correlated by large prospective clinical trials. Besides, pathological inter laboratory variance in standard reporting, qualitative or quantitative assays, available techniques and expertise make us to relook in the accuracy and reliability of the reports in our clinical practice. In our institute, we use some of these markers for adjuvant therapy but a clinical correlation by data examination is much needed to justify the practice. Hence a clinico-pathological correlation prospective study is undertaken to address the issue. Aims and Objectives: To correlate the selected pathological bio markers clinically with treatment response and disease aggressiveness. Materials and methods: A prospective study to find out the co-relation of CA-15(3) serum level, ER/PR andHER-2-neu expression level by IHC, histological grade by Bloom Richardson score with respect to the broad 3 stage groupings viz, early breast cancer, locally advanced breast cancer and metastatic breast cancer. All lab tests will be done at Institute labs as per standardized technique. Patient accrual will be completed in initial 20 months and first result analysis at the end of 2 years. A sample size of 90 patients will be considered and equal number of 30 patients to be enrolled in each assigned 3 study groups. Statistical analysis of treatment outcome of these different stages with the markers will be done by using appropriate statistical techniques applicable like correlation matrix analysis for multi variants using IBM software SPSS version21. Results: A total of 90 female patients were enrolled and followed up for median 9 months. Median age was 45 years and range 27 years to 65 years. Histologically, out of 90 enrolled 85(90%) are IDC, 3(8%) are lobular and 2(2%) are medullary type. Stage wise Stage IV- 9%, stage III -30%, stage II-45% and stage I-14%. Receptors ER and PR both +ve in 40% and 57% -ve. Her2/Neu was strongly(+++) expressed in 48% and moderately (++) in 4% and not expressed at all in remaining 48%. At the time of first data analysis 74 (82%) are in CR and 9 (10%) have died and 7 (8%) have disease recurrence. Bivariate Correlation test was done with different variables with stage and with treatment outcome separately. Both ER and PR has strong positive co relation with treatment outcome by Pearsons test ( value 1 significant at .000 by 2-tailed test at p=.01 level). The significance is also found at P= .000 at .01 confidence level by non parametric test spearman's rho and Kendall'stau_ b test. Bivariate co relation test with Her2/neu expression shows strong positive co relation with value 1 and p value .000 at .01 level. This is because F.U. is short and patients are treated with targeted therapy thereby nullifying the predicted negative prognostic value of this growth factor expression. Conclusion: The early analysis of this study shows a strong positive co relation with histology grade and stage and also with treatment outcome. Hormonal receptors also shows strong positive co relation with treatment outcome as expected but with growth factor Her2/ Neu fail to show -ve co relation with treatment outcome this could be due to short F.U and effective targeted therapy making expression of Her2/Neu not a bad prognosis any more. Longer F.U is required for definite conclusion however the trend shows Hormonal receptors are good prognostic and Her 2/Neu no longer a bad prognostic marker with use of specific targeted therapy. [ABSTRACT FROM AUTHOR]

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