Serum Her-2/Neu a Potential Biomarker in Breast Cancer Patients: Correlation with the Clinico-Pathological Parameters

Abstract

ABSTRACT:BACKGROUND: Breast cancer is the most common malignancy in women, and a major cause of mortality and morbidity despite the advances in diagnosis and treatment. There is evidence that changes in HER2 protein expressions are associated with breast cancer progression.OBJECTIVE: To investigate whether measuring this tumour marker in serum of breast cancer patients before and after treatment might also be useful markers in the diagnosis, screening and monitoring the malignant tumour progression and response to therapy. METHODS: Serum samples were obtained from (28) apparently healthy women (Control Group) with a mean age of 40.9 ± 7.6 years and (60) female patients complaining from primary breast cancer (Patients Group) with a mean age of 48.3 ± 8.9 years. They were divided according to their clinical end point into: Pre-Surgical Group, Post-Surgical Group and post- chemotherapy Group. Serum Her-2/nue level was measured using ELISA kits.RESULTS: Level of Her2/neu (3130.4 pg/ml) was significantly higher in after 6 cycles of chemotherapy group than each of control (1400.8 pg/ml), before surgery (1597 pg/ml) and after surgery (1487.4 pg/ml) (P < 0.05). Her2/neu is effective test only after 6 cycle chemotherapy with an accuracy of 95.2%. The best performance for Her2neu was observed at values ≥ 1464 pg/ml (sensitivity = 95% and specificity = 61%). There were significant influences of the studied personal and the pathological characteristics of the tumour upon the biomarker levels where the levels were significantly higher with the increase of tumour pathological stage and in the presence of positive status for Her2neu receptors (P < 0.05).CONCLUSION:In this study there was a statistically significant association between tissue HER-2/neu and serum HER-2 /neu levels in the extracellular domain. It could be concluded that using serum Her-2/neu in patients after six cycles chemotherapy could predict response to therapy..