PhenoPath. Diagnoses you can count on BREAST. v.1

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Timothy Cole
7 years ago
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1 PhenoPath Diagnoses you can count on BREAST v.1

2 The use of immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) for determinination of prognostic and predictive markers require deep knowledge of, and extensive experience with, the techniques as well as the significance of their results. PhenoPath pathologists and technologists have performed tens of thousands of IHC and FISH determinations of ER, PR and HER2 status of breast cancer specimens over the past 15 years. The extremely high levels of accuracy and reproducibility of Pheno- Path s assays have been demonstrated in our published studies and presented data. Allen M. Gown, MD Patricia Kandalaft, MD Founder, Medical Director Director Breast Pathology Associate Director, IHC PhenoPath Recommends the Following Best Practices for Prognostic & Predictive Markers in Breast Cancer: Positive ER Positive PR Ki-67 high Ki-67 low Amplified HER2 Estrogen (ER) and progesterone (PR) receptor assays:

3 HER2 assays: 2013 ASCO-CAP GUIDELINES Ki-67-defined cell proliferation index: Molecular Subclassification of Breast Cancer: Subclass ER PR HER2 Ki-67 LUMINAL A Positive Positive Negative Low (<15%) LUMINAL B Positive Low Pos or Neg Negative High (>15%) HER2 Pos or Neg Negative Positive High (>15%) BASAL-LIKE Negative Negative Negative High (>15%)

4 Molecular subclassification of breast cancer continued H&E ER PR BASAL-LIKE BREAST VARIANT: This infiltrating carcinoma in a 39-year-old female has a triplenegative immunophenotype (ER-, PR-, HER2-) and shows variegated immunostaining with antibodies to p63 and keratin 5, characteristic of the basal-like subtype of breast cancer. HER2 CK5/6 p63 Additional IHC Uses in Problem Breast Cases DIAGNOSES Hyperplasia v. atypical ductal hyperpasia DCIS v. infiltrating ductal carcinoma Benign sclerosing lesions v. infiltrating carcinoma Ductal v. lobular neoplasia Papillary breast neoplasms - carcinoma v. papilloma Markers of breast carcinomas presenting as metastases Spindle cell lesions of the breast (PASH, metaplastic CA, fibromatosis, myofibroblastoma) USEFUL IHC MARKERS High MW keratin Myoepithelial markers (SMMHC, p63 or p40) Myoepithelial markers (SMMHC, p63 or p40) E-cadherin, ß-catenin Myoepithelial markers (SMMHC, p63 or p40) GATA-3, GCDFP-15, mammaglobin A, estrogen receptor Keratin, p63 or p40, ER, CD34, desmin, smooth muscle actin, ß-catenin Antibodies to myoepithelial-specific proteins, smooth muscle myosin heavy chain (SMMHC) and p63 show retention of outer myoepithelial layer around all tumor cell profiles, pointing to the diagnosis of DCIS rather than infiltrating cribriform carcinoma. Infiltrating pleomorphic lobular carcinoma showing complete absence of expression of E-cadherin. Note positive immunostaining of nonneoplastic breast epithelium which serves as an internal control.

5 Why use PhenoPath? World-class expertise in breast cancer Allen M. Gown, MD, with renowned expertise in breast pathology, has over 280 publications, >50 in breast cancer (collectively over 450 PhenoPath publications) Dr. Gown and Dr. Kandalaft have decades of experience interpreting breast cancer cases and breast marker studies (> 5,000 cases/year) Dr. Gown and colleagues are invited speakers at national & int l conferences PhenoPath pathologists actively participate in guiding the future of diagnostic pathology, holding leadership appointments on national education, consensus and guideline committees, including CAP, USCAP, ICCS, AMP PhenoPath provides diagnostic pathology services to national and international clinical trials studies (over 130 clinical trials in the past four years) Proven quality assurance program PhenoPath s ER, PR and HER2 assays have undergone extensive technical and clinical validation, the latter based on a cohort of approximately 4,000 patients, with a mean clinical follow up of > 12 years PhenoPath is one of the few national labs listed by CAP with clinically validated ER and PR assays PhenoPath s 2013 HER2 IHC-FISH concordance rates of 97.8% (positive) and 99.5 (negative) are well above the ASCO-CAP-recommended concordance rate of 95% PhenoPath s concordance rates are monitory quarterly Customized concordance data can be provided to your institution PhenoPath consistently achieves expected ER, PR and HER2 positivity rates Validation Services PhenoPath offers interlaboratory validation services for all breast markers Recent References / Publications: 1. Polley MY, et al. J Natl Cancer Inst 105: , Wolff, et al. J Clin Onc 31: , Allison KH, et al. Breast Cancer Res Treat 131: , Tse CH, et al. Clin Oncol 29: , Gown AM, et al. Am J Clin Pathol 136:5-6, Dewar R, et al. Arch Pathol Lab Med 135: , Baehner FL, et al. J Clin Oncol 28:4300-6, Gown AM. Mod Pathol 21(S2): S8-S15, Gown AM, et al. Mod Pathol 21: , Turbin DA, et al. Breast Cancer Res Treat 110: , Harris L, et al. J Clin Oncol 25: , Cheang MC, et al. J Clin Oncol 24: , Diagnoses you can count on

6 PhenoPath Diagnoses you can count on 551 N 34th St., Suite 100 Seattle, WA, p: f: For more information, go to Breast cancer markers under: v.1 Feb2014

Changes in Breast Cancer Reports After Second Opinion. Dr. Vicente Marco Department of Pathology Hospital Quiron Barcelona. Spain

Changes in Breast Cancer Reports After Second Opinion Dr. Vicente Marco Department of Pathology Hospital Quiron Barcelona. Spain Second Opinion in Breast Pathology Usually requested when a patient is referred