Several previous studies as well as data to be presented at the 51st Annual ASCO meeting in Chicago, Illinois, demonstrate the clinical value of monitoring serum HER2 levels in breast cancer patients.
Data to be presented by Dr Zhang et al (ASCO-abstract #22038) comes from a prospective trial of 113 patients with stage I–III breast cancer and 207 metastatic breast cancer patients. The study demonstrates that levels of the circulating HER2 extracellular protein can be used as a real time assessment of HER2 tissue status, and an indicator of poor prognosis in HER2 metastatic breast cancer patients.
These studies also show that there is a strong correlation between serum HER2 levels and HER2 tissue status and therefore in Europe serum HER2 can be used as a surrogate biomarker for HER2 in early breast cancer in addition to metastatic breast cancer. Data from these patients demonstrate that the rise and fall of the serum HER2 levels correlated with clinical outcomes and provides important prognostic information in the management of HER2 positive breast cancer. These studies strongly correlate with previous serum HER2 studies in breast cancer patients. Breast cancer patients whose serum HER2 levels were consistently less than 15 ng/ml (normal) had significantly longer survival compared to patients with serum HER2 levels continuously above the normal 15ng/ml.
Numerous studies, in addition to a published meta-analysis of over 4000 breast cancer patients, showed that patients with serum HER2 levels greater than 15ng/ml had a 3.39-4.57 odds of recurrence within 2 years which was not the case in breast cancer patients with serum HER2 levels continuously less than 15ng/ml. The meta-analysis agreed with many previous studies showing that serum HER-2 levels greater than 15ng/ml is a strong prognostic indicator of poor clinical outcome.
Since Trastuzumab is now standard of care for treating both early and late HER2 positive breast cancer the serum HER-2 blood test can routinely be used to monitor the rise and fall of serum HER2 levels and can be used in Europe as an early indicator of cancer progression and as a strong prognostic biomarker in HER2 positive cancer patients.
In Europe, the HER-2/neu ELISA is intended to quantitatively measure the extracellular domain (97–115 kDa) of the HER-2/neu protein in human serum. In the US, the HER-2/neu ELISA is intended to quantitatively measure HER-2/neu protein in serum for follow-up and monitoring of women with metastatic breast cancer.
Nuclea Diagnostic Laboratories, LLC is a wholly owned subsidiary of Nuclea Biotechnologies, Inc. – and is located in Cambridge, Massachusetts. Nuclea has developed and is commercializing unique diagnostic tests for colon, breast, leukemia, lung, and prostate cancer, as well as for diabetes and other metabolic syndromes. Nuclea also performs research leading to novel molecular oncology companion diagnostics for the pharmaceutical and biotechnology industries. To learn more about our HER2 blood test, please visit www.her2bloodtest.com or to learn more about Nuclea Biotechnologies, Inc. please visit www.nucleabio.com