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
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Citations
Breast Cancer Treatment: A Review.
Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care
Triple-negative breast cancer: challenges and opportunities of a heterogeneous disease
PD-L1 Expression as a Predictive Biomarker in Cancer Immunotherapy
References
Effect of high copy number of HER2 associated with polysomy 17 on HER2 protein expression in invasive breast carcinoma.
Fine-needle aspiration for nucleic acid-ased molecular analyses in breast cancer.
Using a higher cutoff for the percentage of HER2+ cells decreases interobserver variability in the interpretation of HER2 immunohistochemical analysis.
PGDS, a novel technique combining chromogenic in situ hybridization and immunohistochemistry for the assessment of ErbB2 (HER2/neu) status in breast cancer.
Performance of chromogenic in situ hybridization on testing HER2 Status in breast carcinomas with chromosome 17 polysomy and equivocal (2+) herceptest results: a study of two institutions using the conventional and new ASCO/CAP scoring criteria
Related Papers (5)
American society of clinical oncology/college of american pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer
Molecular portraits of human breast tumours
Comprehensive molecular portraits of human breast tumours
Frequently Asked Questions (11)
Q2. What are the future works in "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" ?
Although FDA-approved assays have been carefully validated, not all LDTs may have, which complicates direct comparisons across trials and platforms, and the authors maintain that this situation leaves open the possibility that a substantial percentage of some patients with breast cancer could be either over- or undertreated with HER2-targeted therapies. The decision to treat with specific therapies like trastuzumab is by necessity dichotomous ( yes or no ) and will not be informed by an equivocal diagnosis with respect to HER2 status without repeat testing, if possible. However, HER2 test results are derived from a continuous variable, which can be expected to lead to some results falling into a gray area.
Q3. What is the method of obtaining tissue from the primary tumor?
Tissue from the primary tumor can be obtained through a core needle biopsy, as well as from an incisional and excisional surgical procedure.
Q4. What is the term ratio used in the guideline recommendations and algorithms?
The term ratio, as used in the guideline recommendations and algorithms, always applies to the HER2/CEP17 ratio, which means the ratio of HER2 signals per cell (numerator) over CEP17 signals per cell (denominator).
Q5. How did Lund et al examine HER2 testing among female residents?
In the United States, Lund et al151 used data from the National Cancer Institute Metropolitan Atlanta SEER Registry in conjunction with the Georgia Comprehensive Cancer Registry to examine HER2 testing among all cases of primary invasive breast cancer diagnosed among female residents during 2003 to 2004.
Q6. What are the learning opportunities for HER2?
Many of these learning opportunities have a scored assessment component, allowing participants to test their knowledge as part of completing the courses, and can be used to meet the American Board of Pathology (ABP), the US pathologist certifying organization, Maintenance of Certification requirements.
Q7. What is the reason for the small number of patients affected by HER2?
Aside from the very small number of patients affected (as few as 0.15% of all newly diagnosed patients, as previously discussed),5 the Update Committee was also of the opinion that improvements in analytic performance of HER2 testing in clinical practice since 2007 have further reduced the already small number of patients potentially at risk of receiving a false-negative test result.
Q8. What is the definition of amplification in a dual-probe ISH assay?
Amplification in a dual-probe ISH assay is defined by examining first the HER2/CEP17 ratio followed by the average HER2 copy number (see Data Supplement 2E for more details).
Q9. What is the FDA’s recommendation for HER2 testing?
The product package inserts for trastuzumab and pertuzumab prepared by the FDA indicate that ‘‘HER2 testing should be performed using US Food and Drug Administration-approved tests by laboratories with demonstrated proficiency.
Q10. What are the new interpretation requirements for HER2 assays?
New interpretation requirements relate to the definition of tumor samples with genomic heterogeneity as well as the examination of specimens and interpretation of results in these samples.
Q11. What is the responsibility of the treating physician to determine the course of treatment for the patient?
It is the responsibility of the treating physician, relying on independent experience and knowledge, to determine the best course of treatment for the patient.