An expert panel was convened by the College of American Pathologists (CAP) and American Society of Clinical Oncology (ASCO) to consider new evidence that might prompt changes to clinical practices that were established with the 2010 “ASCO-CAP Guideline Recommendations for Immunohistochemical (IHC) Testing of Estrogen and Progesterone Receptors (ER/PgR) in Breast Cancer.”
A draft of key recommendations that update and otherwise reaffirm the 2010 guideline will be open for public comment from April 15-29, 2019. Of note:
- The new guidance recommends additional steps to appropriately address and interpret cases with low or weak ER expression.
- For cases of ductal carcinoma in situ (DCIS) only, the updated draft now recommends ER testing, but PgR testing is still optional.
Open Comment Period Information
By April 29, 2019, all health systems with all levels of IHC experience including US-and international-based laboratories and all stakeholders—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.
The following items should be reviewed in context with the draft recommendations:
American Society of Clinical Oncology
Kimberly Allison, MD, FCAP, Co-Chair
Antonio Wolff, MD, FASCO, Co-Chair
Elizabeth Hammond, MD, FCAP
Mitchell Dowsett, PhD
Lisa McShane, PhD
Lisa Carey, MD
Patrick L. Fitzgibbons, MD, FCAP
Daniel Hayes, MD
Sunil Lakhani, MD, MBA
Jane Perlmutter, PhD, MBA
Chuck Perou, PhD
Meredith Regan, ScD
David Rimm, MD, PhD, FCAP
Fraser Symmans, MD
Emina Emilia Torlakovic, MD, PhD, FCAP
Leticia Varella, MD
Giuseppe Viale, MD
Mariana Chavez Mac Gregor, MD, MSc
Guideline status: Open Comment Period
Published online ahead of print: April 19, 2010
Originally published: June 2010
Accreditation Requirements and Proficiency Testing (PT)
Accreditation checklist requirements regarding ER/PgR assay validation, specimen fixation, and proficiency testing 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 program. Call the CAP customer contact center at 1-800-323-4040 option 1#.
Gain the practical skills, tools, and techniques needed to ensure testing accuracy as well as compliance with ASCO-CAP Guidelines for HER2 and ER/PgR testing.
The information, data, and draft recommendations provided by the ASCO-CAP are presented for informational and public feedback purposes only.
The draft recommendations and supporting documents will be removed public domain on April 29, 2019.
These draft materials should not be stored, adapted, cited, or redistributed in any manner.
Please note: All comments will be posted on a weekly basis beginning April 22 through April 29, 2019.
Following the open comment period, the expert panel will consider all feedback to finalize the recommendations. The final recommendations will be included in a manuscript to be submitted for publication in the Journal of Clinical Oncology and Archives of Pathology & Laboratory Medicine.
Through its Pathology and Laboratory Quality Center for Evidence-based Guidelines, the CAP develops recommendations related to the practice of pathology and laboratory medicine. Through this work, the CAP and its members continually improve the quality of diagnostic medicine and patient outcomes. For questions, please contact CENTER@CAP.ORG.
Review more upcoming CAP evidence-based guidelines by the Pathology and Laboratory Quality Center for Evidence-based Guidelines.