Breast Cancer ER/PR IHC Assays

Overview

Estrogen and progesterone are steroid hormones that are associated with promoting the development of breast cancer. The ER (estrogen receptor) and PR (progesterone receptor) status is a predictor of increased response rates to endocrine therapy in breast cancer patients. Patients with ER and/or PR-positive early stage breast cancer undergoing tamoxifen or other endocrine therapy have substantially lower risk for breast cancer reoccurrence and death across all age groups. Patients with ER and/ or PR-negative breast cancer do not show benefit from tamoxifen. ER and PR testing is also used to predict response to endocrine therapy in the metastatic setting. Higher amounts of ER have been positively correlated with increased response rates to tamoxifen treatment. PR-positive status is an indicator of functional ER. ER and PR status is determined using IHC in almost all cases despite the high false-negative rate associated with it.

Clinical Indications
Breast Cancer.

Clinical Utility

Aids in indentifying patients with different risks of relapse, survival and treatment response. Assesses patients for endocrine therapy such as tamoxifen.

Methodology and Interpretation

Immunohistochemistry (IHC) testing to determine and quantitate ER/PR expression in formalin-fixed paraffin-embedded (FFPE) human breast cancer tissue using Rabbit monoclonal antibodies (CONFIRM anti-ER (SP1) and CONFIRM anti-PR (1E2)) from the Ventana Medical System, Inc. The tests are run on the Ventana automated immunostainer. The results are interpreted and reported in adherence to the 2010 American Society of Clinical Oncology-College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Estrogen and Progesterone Receptors in Breast Cancer.

NCCN Guidelines*

NCCN Guidelines suggests both ER and PR status testing for all invasive breast cancers and ductal carcinoma in situ (DCIS). ER/PR testing should be performed at primary diagnosis and at first relapse. Due to the high false-negative rate, the NCCN recommends retests for ER/PR negative results if the tumor grade is 1 as well as if tumor histology is lobular, tubular or mucinous because these types of tumors are rarely negative. If a core biopsy is negative for ER/PR, testing should also be repeated unless there are internal controls that are positive.

Assay Specifications

Reporting Results are reported as: ER and/or PR-positive if 1% of cells are stained. ER and/or PR-negative if <1% of cells are stained. TAT 24-48 hours CPT Codes 88342x2

Specimen Requirements 10% neutral buffered formalin-fixed paraffin-embedded (FFPE) tissue. 3-5m thick FFPE sections on positively coated slides. Stored and transported at room temperature. Licensure CAP (Laboratory #: 7191582, AU-ID: 1434060), CLIA (Certificate #: 31D1038733), New Jersey (CLIS ID #: 0002299), New York State (PFI: 8192), Pennsylvania (031978), Florida (800018142), Maryland (1395)

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Patient Name: Sex: q Male q Female Date of Birth: Specimen: Collected: Received: Reported: Clinical Hx:

Accession Number: CGI ID No: Ordering Physician: Client: Client Account No: Client ID No: Client Address: Telephone:

ANATOMIC PATHOLOGY SAMPLE REPORT

Final Diagnosis: Breast Cancer Therapeutic Marker Studies by IHC Results In-situ Ductal Carcinoma Markers ER PR Comment: % Positive Cells 60% 90% Staining Intensity 1+ 2+ Interpretation POSITIVE POSITIVE

Only in-situ ductal carcinoma is present on the block submitted (confirmed by p63 and smooth muscle myosin heavy chain stains). If there is invasive carcinoma, and ER/PR/HER2 testing is desired, re-submitting a block with invasive carcinoma is recommended. Positive and negative controls are satisfactory. Time to fixation and duration of fixation were not provided. Reference Range for ER/PR: Positive: >1% nuclear stain Negative: <1% nuclear stain

Gross Description:

Received are 4 paraffin embedded tissue blocks labeled with 12-527 A-D. (The stains are performed at the Clarient Diagnostic Services, CA, and interpreted in our department)

End of Report

201 Route 17 North Rutherford NJ 07070 Office 201.528.9200 Fax 201.528.9201 www.cancergenetics.com

041013 2013 Cancer Genetics, Inc. All rights reserved.