Recommendations for Human Epidermal Growth Factor 2 Testing in Breast Cancer

 
Both ASCO and CAP are committed to maintaining and updating guidelines as new evidence becomes available. ASCO and CAP will reconvene the HER2 Testing Update Committee to develop and publish a focused update on recent issues brought forth. Further information may be found in the Journal of Clinical Oncology letter to the editor and reply. A separate editorial is available in the Archives of Pathology and Laboratory Medicine.

Background

The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) issued a joint, updated guideline aimed at improving the accuracy and reporting of human epidermal growth factor receptor 2 (HER2) testing in patients with invasive breast cancer.

The guideline update is based on a systematic review of medical research literature, providing oncologists and pathologists with detailed recommendations for how to test for HER2 gene overexpression, interpret the results, and recommend HER2-targeted therapies.

The guideline, originally issued in 2007, provides new and revised recommendations on HER2 testing to identify patients who can benefit from effective HER2-targeted therapies, such as trastuzumab (Herceptin), pertuzumab (Perjeta), lapatinib (Tykerb), and T-DM1 (Kadcyla).

These treatments can substantially improve survival in patients with HER2-positive invasive breast cancer. It is important to accurately determine the HER2 status to ensure that patients most likely to benefit are offered an HER2-targeted treatment, and those that are unlikely to benefit can avoid costs and side effects associated with those drugs.

The complete guideline was published for early online release on October 7, 2013.

Change to the Recommendation

In the twelfth row of Table 1, the 2013 recommendation for optimal initial test validation incorrectly stated:

"This requirement does not apply to assays that were previously validated in conformance with the 2007 ASCO/CAP HER2 testing guideline or to those who are routinely participating in external proficiency testing for HER2 tests, such as the program offered by CAP (Data Supplement 12),"

whereas it should have read:

"This requirement does not apply to assays that were previously validated in conformance with the 2007 ASCO/CAP HER2 testing guideline and to those who are routinely participating in external proficiency testing for HER2 tests, such as the program offered by CAP (Data Supplement 12)."

Guideline Resources

The data supplement provides the project's comprehensive literature review, evidence grading, and considered judgment process.

Download the following:


Education

Learn how to apply the ASCO/CAP Guideline recommendations.


HER2 Tissue Donations

Donate laboratory tissue samples for the CAP proficiency testing programs. Contact Patty Vasalos, technical analyst: email or call 1-800-323-4040, ext. 7584


Accreditation Requirements and Proficiency Testing (PT)

Accreditation checklist requirements regarding HER2 assay validation, specimen fixation, proficiency testing, and use of the ASCO/CAP scoring criteria for reporting results are included in the anatomic pathology (ANP), cytogenetics (CYG), and molecular pathology (MOL) checklists.

These checklists are available to CAP accredited laboratories through e-LAB Solutions Suite or can be purchased by non-CAP accredited laboratories.

Meet PT requirements by ordering the appropriate HER2 PT program. Call the CAP customer contact center at 1-800-323-4040 option 1#.


Information for Patients

 

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