Estrogen and Progesterone Receptor Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Guideline Update

Author:

Allison Kimberly H.1,Hammond M. Elizabeth H.2,Dowsett Mitchell3,McKernin Shannon E.4,Carey Lisa A.5,Fitzgibbons Patrick L.6,Hayes Daniel F.7,Lakhani Sunil R.89,Chavez-MacGregor Mariana10,Perlmutter Jane11,Perou Charles M.5,Regan Meredith M.12,Rimm David L.13,Symmans W. Fraser10,Torlakovic Emina E.1415,Varella Leticia16,Viale Giuseppe1718,Weisberg Tracey F.19,McShane Lisa M.20,Wolff Antonio C.21

Affiliation:

1. From theStanford University School of Medicine, Stanford, CA

2. Intermountain Healthcare, Salt Lake City, UT

3. Royal Marsden Hospital, London, United Kingdom

4. American Society of Clinical Oncology, Alexandria, VA

5. University of North Carolina, Chapel Hill, NC

6. St Jude Medical Center, Fullerton, CA

7. University of Michigan, Ann Arbor, MI

8. University of Queensland, Brisbane, Queensland, Australia

9. Pathology Queensland, Brisbane, Queensland, Australia

10. MD Anderson Cancer Center, Houston, TX

11. Gemini Group, Ann Arbor, MI

12. Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA

13. Yale Cancer Center, New Haven, CT

14. Saskatchewan Health Authority, Saskatoon, Saskatchewan, Canada

15. University of Saskatchewan, Saskatoon, Saskatchewan, Canada

16. Weill Cornell Medicine, New York, NY

17. IEO, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy

18. University of Milan, Milan, Italy

19. Maine Center for Cancer Medicine, Scarborough, ME

20. National Cancer Institute, Rockville, MD

21. Johns Hopkins University, Baltimore, MD

Abstract

Purpose.—To update key recommendations of the American Society of Clinical Oncology/College of American Pathologists estrogen receptor (ER) and progesterone receptor (PgR) testing in breast cancer guideline.Methods.—A multidisciplinary international Expert Panel was convened to update the clinical practice guideline recommendations informed by a systematic review of the medical literature.Recommendations.—The Expert Panel continues to recommend ER testing of invasive breast cancers by validated immunohistochemistry as the standard for predicting which patients may benefit from endocrine therapy, and no other assays are recommended for this purpose. Breast cancer samples with 1% to 100% of tumor nuclei positive should be interpreted as ER positive. However, the Expert Panel acknowledges that there are limited data on endocrine therapy benefit for cancers with 1% to 10% of cells staining ER positive. Samples with these results should be reported using a new reporting category, ER Low Positive, with a recommended comment. A sample is considered ER negative if < 1% or 0% of tumor cell nuclei are immunoreactive. Additional strategies recommended to promote optimal performance, interpretation, and reporting of cases with an initial low to no ER staining result include establishing a laboratory-specific standard operating procedure describing additional steps used by the laboratory to confirm/adjudicate results. The status of controls should be reported for cases with 0% to 10% staining. Similar principles apply to PgR testing, which is used primarily for prognostic purposes in the setting of an ER-positive cancer. Testing of ductal carcinoma in situ (DCIS) for ER is recommended to determine potential benefit of endocrine therapies to reduce risk of future breast cancer, while testing DCIS for PgR is considered optional. Additional information can be found at www.asco.org/breast-cancer-guidelines.

Publisher

Archives of Pathology and Laboratory Medicine

Subject

Medical Laboratory Technology,General Medicine,Pathology and Forensic Medicine

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