Breast Cancer Guideline Updates


The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) has extended the draft recommendations and guideline feedback for professional and public comment until June 19, 2017 on:

  1. Draft Recommendations from the 2017 ASCO/CAP Focused Update Guideline Recommendations for Human Epidermal Growth Factor Receptor 2 (HER2) Testing in Breast Cancer.
  2. General input for possible revision to the 2010 ASCO/CAP Guideline Recommendations for Immunohistochemical (IHC) Testing of Estrogen and Progesterone Receptors (ER/PgR) in Breast Cancer.

The information, data, and draft recommendations that ASCO and the CAP provide here are presented for informational and public feedback purposes only. The draft recommendations and supporting documents will be removed from public domain on June 19, 2017. All comments received will be made available for public viewing until June 26, 2017. These draft materials should not be stored, adapted, or redistributed in any manner.

All stakeholders including oncologists, pathologists, surgeons, nurses, allied health professionals, hospital or laboratory administrators, public health and industry professionals, patient advocacy group representatives, and patients are urged to review and provide commentary. All health systems with all levels of IHC and in situ hybridization (ISH) experience including US and international based laboratories are encouraged to submit comments.

HER2 Testing in Breast Cancer – Focused Update Background

ASCO and the CAP co-published the first "Recommendations for HER2 Testing in Breast Cancer" in October 2007, and followed this important work with an update based on emerging evidence in 2013.

Notably, this 2017 Focused Update addresses uncommon clinical scenarios to improve clarity, particularly for infrequent HER2 test results by in situ hybridization that are of uncertain biologic or clinical significance.

ASCO and CAP recommend that oncologists and pathologists continue to follow the ASCO/CAP 2013 HER2 Testing Guideline published recommendations until the official release and publication of the Focused Update. In the meantime, they may continue to discuss challenging, uncommon cases with experienced colleagues and obtain second opinions when necessary in view of the limited outcome data for such cases.

Five clinical questions raised since publication of the 2013 guideline update are addressed in the Focused Update:

  1. Clinical Question 1 – What is the most appropriate definition for IHC 2+ (IHC Equivocal)?
  2. Clinical Question 2 – Must HER2 testing be repeated in a surgical specimen if initially negative test on core biopsy?
  3. Clinical Question 3 – Should invasive cancers with a HER2/CEP17 ratio > 2.0 but an average HER2 copy number < 4.0 signals/cell be considered in situ hybridization (ISH) Positive?
  4. Clinical Question 4 – Should invasive cancers with an average HER2 copy number > 6.0 signals/cell but a HER2/CEP17 ratio < 2.0 be considered ISH Positive?
  5. Clinical Question 5 – What is the appropriate diagnostic work-up for invasive cancers with an average HER2 copy number > 4.0 but < 6.0 signals/cell and a HER2/CEP17 ratio < 2.0 and initially deemed to have an equivocal HER2 test result?

Draft recommendations are predicated on the assumption that the tissue samples have been properly fixed, processed, and testing is performed in a laboratory that follows ASCO/CAP HER2 testing guideline recommendations, especially those related to IHC and ISH interpretation and reporting. The HER2 Focused Update resources are:

ER/PgR Testing Guideline Background

ASCO and the CAP are also interested in receiving comments to consider for deliberation on the "2010 ASCO/CAP Guideline Recommendations for IHC Testing of Estrogen and Progesterone Receptors (ER/PgR) in Breast Cancer." Input regarding any clinical concerns, issues, and/or any published or unpublished data is welcome. No official date for release of the ER/PgR Testing guideline update has been set.


Open Comment Period

Provide comments on the Draft Recommendations for 2017 HER2 Testing Breast Focused Update until June 19

Call for Feedback

Provide feedback on the 2010 ER/PgR Testing guideline until June 19