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Bladder Cancer, c-erb-b2 Amplification Test, Urinary Bladder (UCB)
Submit a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block. Blocks prepared with alternative fixation methods may be acceptable; provide fixation method used.
The HER2 FISH test is not approved by the FDA for this indication and should be used as an adjunct to existing clinical and pathologic information.
Optimum fixation should be between 6 and 72 hours in 10% neutral buffered formalin. Other types of fixatives should not be used.
The prognostic information provided by the HER2 status of a patient's tumor should not be interpreted in isolation because other prognostic features (eg, lymph node status, tumor size) may be of equal or greater importance in determining the patient's prognosis.
Human epidermal growth factor receptor 2 (HER2) plays a fundamental role in cell growth, survival, and migration. The assessment of HER2 gene status is crucial for the management of breast cancer. Studies have shown that HER2 is also expressed in a proportion of urothelial carcinoma of the urinary bladder (UCB), making it a potential target for UCB therapy.
HER2-positive gene status is associated with aggressive UCB and provides independent prognostic information. Assessment of HER2 status may be used to identify patients at high risk of disease progression.
An interpretive report will be provided. Results are interpreted utilizing the 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for breast tumors.
Specimens with equivocal results as defined by 2013 ASCO/CAP guidelines will no longer have reflex testing performed using an alternative FISH probe set. The report will include a complete interpretation including the HER2:D17Z1 results.
The degree of HER2 amplification varies in tumors. Some exhibit high levels of amplification (HER2:D17Z1 ratio >4.0), whereas others exhibit low-level amplification (HER2:D17Z1 ratio of 2.0-4.0). It is not currently known if patients with different levels of amplification have the same prognosis and response to therapy.
Reports also interpret the HER2 copy number changes relative to chromosome 17 copy number (aneusomy) or potential structural genomic abnormalities that increase HER2 copy number.
Rare cases may not show HER2 amplification but still have human epidermal growth factor receptor 2 (HER2) protein overexpression demonstrated by immunohistochemistry. The clinical significance of HER2 protein overexpression in the absence of HER2 gene amplification is unclear. However, these patients may have a worse prognosis and be candidates for treatments that target the HER2 protein or its downstream pathways.