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.
Recommendations for Human Epidermal Growth Factor 2 Testing in Breast Cancer
Detailed information regarding the project’s comprehensive literature review, evidence grading and considered judgment process, etc., may be accessed in the Supplemental Digital Content available online.
Note the following change to the recommendation on Optimal initial test validation:
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).”
Summary of Recommendations (PDF, 285 KB)
HER2 Testing Algorithms
See Frequently Asked Question for further information on HER2 Testing in Breast Cancer.
(PDF, 66 K)
See Frequently Asked Question for information on HER2 Testing in Gastric Cancer.
(PDF, 188 K)
HER2 PowerPoint Presentation
(PowerPoint, 1.6 MB)
CAP’s Multidisciplinary Breast Pathology Advanced Practical Pathology Program (MBP AP3) offers both online learning and a live workshop, and includes cognitive and practical assessments. MBP AP3 covers the entire breast disease spectrum, from understanding the latest research on hyperplasia and ductal carcinoma in situ to factors of breast conservation. Learn how to apply the ASCO/CAP Guideline recommendations while integrating pathologic findings with the entire clinical picture and understand the treatment implications of these results.
If your laboratory can be a source of material to the CAP proficiency testing programs, please contact Patty Vasalos, Technical Analyst, by email or by calling 800-323-4040, ext. 7584.
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 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#
Read the Patient Guide (PDF, 227 KB) for further information.
For more information, visit:
Comment on the recommendations.