Immunohistochemical expression of HER2 in breast cancer: socioeconomic impact of inaccurate tests
نویسندگان
چکیده
BACKGROUND Treatment for patients with breast cancer (BC) is guided by human epidermal growth factor receptor 2 (HER2) status. The patient's HER2 status is assessed using US Food and Drug Administration-approved in vitro diagnostic (IVD) immunohistochemical (IHC) tests and laboratory-developed IVD tests. We analysed HER2 testing accuracy using data from the Nordic Immunohistochemistry Quality Control (NordiQC) HER2 IHC programme; results were used in an economic BC treatment model. METHODS Data were obtained from NordiQC HER2 BC surveys performed from 2008 to 2012. False-negative (FN) and false-positive (FP) rates for approved and laboratory-developed IVDs were used to estimate direct costs, loss of survival, productivity benefit and quality-adjusted life-years. In the absence of consistent and accessible clinical and economic data from countries participating in the NordiQC programme, United States productivity data, healthcare costs and patient numbers were used as a surrogate in order to estimate the potential impact of selecting an approved or laboratory-developed IVDs. RESULTS In total, 1703 tests were performed. Pooled FN rates were 11% for approved IVDs and 25% for laboratory-developed IVDs; FP rates were 0% and 5%, respectively. Using these FP and FN rates in the economic model and applying them to the United States BC population, approved IVD tests would result in better clinical outcomes, i.e., better survival and fewer disease recurrences/progressions, and lower costs, i.e., total direct costs and lost productivity, versus laboratory-developed IVD tests. Every $1 saved by laboratories by using cheaper reagents could potentially result in approximately $6 additional costs to the healthcare system. CONCLUSIONS The results of this analysis suggest that incorrect HER2 test results have far-reaching clinical and economic consequences.
منابع مشابه
Steroid hormone receptors, MIB-1, p53, and c-erb-B2 expression on breast cancer: Comparison of immunohistochemistry on cell block and fine needle aspiration and tissue sample, in northwest Iran
Background: Fine-needle aspiration of breast cancer often provides moderate cellular material that is representative of the tumors. These samples can be used not only for cytological diagnosis but also to obtain information on the prognosis and likely response to therapy by using immunohistochemical staining studies. Methods: We assessed the degree of correlation between prognostic biologic ma...
متن کاملIdentification of Prognostic Genes in Her2-enriched Breast Cancer by Gene Co-Expression Net-work Analysis
Introduction: HER2-enriched subtype of breast cancer has a worse prognosis than luminal subtypes. Recently, the discovery of targeted therapies in other groups of breast cancer has increased patient survival. The aim of this study was to identify genes that affect the overall survival of this group of patients based on a systems biology approach. Methods: Gene expression data and clinical infor...
متن کاملCytoplasmic Her2/neu immunohistochemical staining in breast cancer; From a molecular point of view
متن کامل
Comparing the Effect of Silybin and Silybin Advanced™ on Viability and HER2 Expression on the Human Breast Cancer SKBR3 Cell Line by no Serum Starvation
The polyphenol silybin has anti-oxidant and anti-cancer properties. The poor bioavailability of some polyphenols (flavonoids, and terpenoids) can be improved by binding them to phosphatidylcholine (phytosome technology). Many studies have focused on the most common phytosome, silybin-phosphatidylcholine, particularly for its hepatoprotective effects. However, in recent years, studies have also ...
متن کاملComparing the Effect of Silybin and Silybin Advanced™ on Viability and HER2 Expression on the Human Breast Cancer SKBR3 Cell Line by no Serum Starvation
The polyphenol silybin has anti-oxidant and anti-cancer properties. The poor bioavailability of some polyphenols (flavonoids, and terpenoids) can be improved by binding them to phosphatidylcholine (phytosome technology). Many studies have focused on the most common phytosome, silybin-phosphatidylcholine, particularly for its hepatoprotective effects. However, in recent years, studies have also ...
متن کامل