Breast Tumors, HER2 Testing

Full Title: HER2 Testing to Manage Patients with Breast or Other Solid Tumors

Expected Release Date: early 2008

Key Questions*

1. What is the evidence on concordance and discrepancy rates for methods (e.g., FISH, IHC, etc.) used to analyze human epidermal growth factor receptor 2 (HER2) status in breast tumor tissue?
2. For patients who are not unequivocally HER2-positive, what is the evidence on outcomes of treatment targeting the HER2 molecule (trastuzumab, etc.), or on differences in outcomes of a common chemotherapy or hormonal therapy regimen with versus without additional treatment targeting the HER2 molecule, in:
   1. Breast cancer patients characterized by discrepant HER2 results from different tissue assay methods performed adequately?
   2. For those with HER2 negative breast cancer?
3. For breast cancer patients, what is the evidence on clinical benefits and harms of using HER2 assay results to guide selection of:
   1. Chemotherapy regimen?
   2. Hormonal therapy?
4. What is the evidence that monitoring serum or plasma concentrations of HER2 extracellular domain in patients with HER2-positive breast cancer predicts response to therapy, or detects tumor progression or recurrence, and if so, what is the evidence that decisions based on serum or plasma HER2 assay results improve patient management and outcomes?
5. In patients with ovarian, lung, prostate, or head and neck cancers, what is the evidence that testing tumor tissue for HER2 or monitoring serum or plasma concentrations of HER2 either predicts response to therapy, or detects tumor progression or recurrence; and if so, what is the evidence that decisions based on HER2 assay results improve patient management and outcomes?

*To be addressed in evidence report.

Current as of April 2007

Internet Citation:

HER2 Testing to Manage Patients with Breast or Other Solid Tumors, Clinical Focus. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/tp/her2tp.htm