Article

Recommendations for Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Update

College of American Pathologists, Northfield, Illinois, United States
Archives of pathology & laboratory medicine (Impact Factor: 2.84). 02/2007; 131(1):18-43. DOI: 10.1043/1543-2165(2007)131[18:ASOCCO]2.0.CO;2
Source: PubMed

ABSTRACT

Purpose:
To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer.

Methods:
ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing.

Results:
The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations.

Recommendations:
The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patients with invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to >10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification (HER2 copy number or HER2/CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing.

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Available from: Elizabeth Hale Hammond, Sep 23, 2015
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    • "Tumours were considered to be hormone receptor (HR)-positive if they were positive for either ER or PR, and HR-negative if they were negative for both ER and PR. HER2 overexpression status was determined according to the American Society of Clinical Oncology (ASCO) guidelines (Wolff et al, 2007). "
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    • "determining which patient will benefit from trastuzumab treatment in both adjuvant and metastatic settings. The ASCO/CAP guidelines (Wolff et al., 2013) recommend initial HER2 screening of all BC, followed by ISH for samples with equivocal staining; the results of these tests determine a patient's eligibility for trastuzumab. However, lack of concordance between IHC and ISH (IHC-negative/ISH-positive ) occurs in up to 11.5% of cases (Hanna et al., 2014). "
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    • "Classification of breast cancers by immunohis- tochimestry HER2 immunostaining were considered positive as described in the Guideline of College of American Pathologists and controlled by a FISH technique for all cases (HercepTest ® Dako) [31]. ER and PR were subsequently scored using a score consisting to sum the intensity and proportion of the nuclear immunostaining. "
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