The 12-gene DCIS Score Assay and Quantitative Gene Expression for ER, PR, and HER2: Experience with 3,947 Patients Alvarado MD, 1 Tan V, 2 Bailey H, 2.

Slides:

Advertisements

Similar presentations

THE RETROSPECTIVE ANALYSIS OF GENE SPECIFIC ONCOTYPE DX ASSAY IN PATIENTS WITH BREAST CANCER (TURKISH CASES) Göker E 1, Görümlü G 1, Batıgün O 2 1 University.

Advertisements

Regulation of Consumer Tests in California AAAS Meeting June 1-2, 2009 Beatrice OKeefe Acting Chief, Laboratory Field Services California Department of.

Oncotype DX® Breast Cancer Assay Clinical Data Review

The Present and Future of Genomics in DCIS

Implicaciones clínicas de los subtipos intrínsecos de cáncer de mama

Triple-Negative Breast Cancer

Comparison of Mutations and Protein Expression in Potentially Actionable Targets in 5500 Triple Negative vs. non-Triple Negative Breast Cancers Joyce A.

Clinical Trial Designs for the Evaluation of Prognostic & Predictive Classifiers Richard Simon, D.Sc. Chief, Biometric Research Branch National Cancer.

Is mammacarcinoom onder de veertig jaar morfologisch en genetisch een andere ziekte? Marc van de Vijver, Netherlands Cancer Institute, Amsterdam, NL.

Breast Pathology Helge Stalsberg MD University Hospital of North Norway.

Evaluation of HR[ER/PgR] status and correlation with Ki67 expression in BC Gayatri Gogoi, MD Assistant Professor Deptt of Pathology, Assam Medical College,

The Call (a brief tour of breast cancer) Family Medicine Review Course 2011 Christian Cable, MD, FACP.

Personalized Breast Cancer Care Sunil Patel, MD Medical Oncology and Hematology Collom and Carney Clinic.

Geonomics in Breast Cancer Decoding Human Genome Luis Barreras, M.D., FACP.

Predictors of HER2 FISH amplification in immunohistochemistry score 2+ infiltrating breast cancer: a single institution analysis Maria Vittoria Dieci 1,

Diagnostic Assays to Plan Specific Drug Treatment Elizabeth Hammond MD.

Metastatic Breast Cancer: One Size Does Not Fit All Clifford Hudis, M.D. Chief, Breast Cancer Medicine Service MSKCC.

Oncotype DX a Genomic Approach to Breast Cancer

1 The Role of the Oncotype DX ® Breast Cancer Assay in the Neoadjuvant Setting.

CELLULAR BIOLOGY IN BREAST CANCER JESSE ELLMAN MD SEPT 2010 CLINICAL ASSISTANT PROFESSOR DEPT OB GYN AND WOMENS HEALTH WE MAY BE ENTERING A NEW PHASE.

Driving the Transition to Individualized Cancer Treatment by Addressing Critical Questions 1 Do I need surgery? chemotherapy? radiation? INVASIVE BREAST.

Introduction MarkerPolymorphisms in CYP2C19 (*2 and *17) assessed by Taqman allelic discrimination ObjectivesTo evaluate the predictive capacity of CYP2C19.

Gianni L et al. Proc SABCS 2012;Abstract GS6-7.

Tang G et al. Proc SABCS 2010;Abstract S4-9.

A 14-gene prognosis signature predicts metastasis risk in node-negative, estrogen receptor-positive, Tamoxifen-treated breast cancer in different ethnogeographic.

Appendix Supplementary data (online only) to: Marleen Kok, Wilbert Zwart, Caroline Holm, Renske Fles, Michael Hauptmann, Laura J. Van ’t Veer, Lodewyk.

Enabling biomarker validation in breast cancer molecular subtypes: sensitivity and specificity of array-based subtype classification in 983 patients Balázs.

NYU Medical Grand Rounds Clinical Vignette Daniel P. Eiras, MD, MPH PGY2 December 1, 2010 U NITED S TATES D EPARTMENT OF V ETERANS A FFAIRS.

Validation of a 12-Gene Colon Cancer Recurrence Score ® in Stage II Colon Cancer Patients from CALGB 9581 A.P. Venook 1, D. Niedzwiecki 2, M. Lopatin 3,

The Value of an Intermediate Recurrence Score® Result in the Oncotype DX® Assay GHI10014_0511.

Sgroi DC et al. Proc SABCS 2012;Abstract S1-9.

Ductal Carcinoma In Situ Shahla Masood, M.D. Professor of Pathology University of Florida College of Medicine - Jacksonville Chief of Pathology and Laboratory.

Metabolic Syndrome and Recurrence within the 21-Gene Recurrence Score Assay Risk Categories in Lymph Node Negative Breast Cancer Lakhani A et al. Proc.

Genomic Health, Inc. Yuko Soneoka, Ph.D., J.D. Senior Corporate Counsel, IP Director of Intellectual Property January 31, 2013.

BIOMARKERS Diagnostics and Prognostics. OMICS Molecular Diagnostics: Promises and Possibilities, p. 12 and 26.

Dubsky P et al. Proc SABCS 2012;Abstract S4-3.

Trials of Adjuvant Trastuzumab in HER2+ Early-Stage Breast Cancer Trial Study Regimen No. of Patients Disease-Free Survival (%) Hazard Ratio P-Value Overall.

Breast Cancer. Introduction  As old as 1600 BC  Emerges from inner lining of milk ducts  Or the lobules that supply milk  Types:  DCIS  LCIS.

Breast cancer in elderly patients (70 years and older): The University of Tennessee Medical Center at Knoxville 10 year experience Curzon M, Curzon C,

Snyder D, Heidel RE, Panella T, Bell J, Orucevic A University of Tennessee Medical Center – Knoxville Departments of Pathology, Surgery, and Medicine BREAST.

Effect of 21-Gene Reverse- Transcriptase Polymerase Chain Reaction Assay on Treatment Recommendations in Patients with Lymph Node-Positive and Estrogen.

Epigenetic Control of Tamoxifen Resistant Breast Cancer Kristin Williams Arcaro Lab Thesis Resarch June 25, 2012 Kristin Williams Arcaro Lab Thesis Resarch.

Prognostic Value of Genomic Analysis After Neoadjuvant Chemotherapy for Breast Cancer Mayer EL et al. Proc SABCS 2010;Abstract P

Use of Oncotype Dx® Testing Breast SSG meeting 10 th July 2015 Dr Rebecca Bowen.

The Use of Pathologic Factors to Assist in Establishing Adequacy of Excision Prior to Radiation Therapy in Patients Treated with Breast Conserving Therapy.

Scatter Plots. Scatter plots are used when data from an experiment or test have a wide range of values. You do not connect the points in a scatter plot,

Scott Kopetz, MD, PhD Department of Gastrointestinal Medical Oncology

A B C Supplementary Figure S1. Time-dependent assessment of grade, GGI and PAM50 in untreated patients Landmark analyses of the Kaplan-Meier estimates.

R3 정수웅 / Prof. 김시영 This article was published on September 28, 2015, at NEJM.org. DOI: /NEJMoa Prospective Validation of a 21-Gene Expression.

Tumor Marker Phenotype Concordance in Second Primary Breast Cancer Monica Brown, MPH, PhD California Cancer Registry Mary Paré, RN, BS Sutter Cancer Center,

How Do We Treat HR positive Breast Cancer in Postmenopausal Women?

Design and Multiseries Validation of a Web-Based Gene Expression Assay for Predicting Breast Cancer Recurrence and Patient Survival Ryan K. Van Laar The.

Case 6 A 49 year old female was found to have a 1.3 cm spiculated mass on screening mammogram Ultrasound revealed a 1.2 cm hypoechoic mass with posterior.

Triple Positive Breast Cancer: A Distinct Subtype Shoaib Junejo MD, Keerat Rai Ahuja MD, Vincent Rizzo MD, Tayyaba Bashir MD. Department of Medicine, NYC.

Genetic Testing for Cancer: Diagnostic Medicine & Cancer Susceptibility Gail H. Vance, M.D. Professor, Medical & Molecular Genetics Indiana University.

San Antonio Breast Cancer Symposium – December 6-10, 2016

Mamounas EP et al. Proc SABCS 2012;Abstract S1-10.

Figure 1. Correlation between estrogen receptor (ER), progesterone receptor (PR), and Ki-67 expression in primary breast tumors and synchronous axillary.

Ari Brooks, MD Cancer Surgeon, Big Data End User

Figure 2. DNA methylation mediated MORT gene silencing is linked to luminal, receptor positive breast cancers. (A) MORT expression level plotted versus.

Transcriptional heterogeneity of breast cancer subtypes,

Prognostic and Predictive Value of the 21-Gene Recurrence Score Assay in Postmenopausal Women with Node-Positive, Estrogen- Receptor-Positive Breast Cancer.

A Long Noncoding RNA Signature That Predicts Pathological Complete Remission Rate Sensitively in Neoadjuvant Treatment of Breast Cancer Gen Wang, Xiaosong.

Diagnostics and Prognostics

Sarah-Jane Schramm, Anna E. Campain, Ricenterd A

Quality Assurance of RNA Expression Profiling in Clinical Laboratories

Validation and Reproducibility of a Microarray-Based Gene Expression Test for Tumor Identification in Formalin-Fixed, Paraffin-Embedded Specimens Raji.

Clustering analysis of DTC-associated genes.

Presentation transcript:

The 12-gene DCIS Score Assay and Quantitative Gene Expression for ER, PR, and HER2: Experience with 3,947 Patients Alvarado MD, 1 Tan V, 2 Bailey H, 2 Anderson J, 2 Rothney M, 2 Baehner FL, 1-2 Sing AP 2 1 Department of Pathology, University of California, San Francisco, CA ; 2 Genomic Health, Inc., Redwood City, CA Objective: To examine the quantitative expression of the estrogen receptor (ER), progesterone receptor (PR), Her-2/neu receptor (HER2), and DCIS Score™ result across clinicopathologic variables (patient age, specimen type, DCIS subtypes) from submitted patient samples tested in the Genomic Health laboratory Methods: A total of 3,947 patient samples from December 2011 through June 2014 that passed pathology review and RT-PCR quality measures were included. The Oncotype DX® assay for DCIS is the first molecular assay that gives additional independent and individualized estimates of 10-year risk of any local recurrence (LR) and invasive LR. Solin JNCI 2013

The distribution of DCIS Score groups (n=3,947) was similar to the distribution observed within the ECOG 5194 validation study Risk GroupNPercentE5194 Study DCIS Score <39 (Low) %70.3% DCIS Score (Intermediate) %16.2% DCIS Score ≥55 (High) %13.5% Solin JNCI 2013

DCIS Score Result, ER, PR and HER2 by Tumor Type 3 There was a wide range of mean values for DCIS Score result and single gene expression across tumor types. Mean Tumor TypeN(%)DCIS Score (range) ERPRHER2 Cribriform1575 (39.9%) 22 (0-90) Solid1371 (34.7%) 34 (0-100) Comedonecrosis462 (11.7%) 47 (0-100) Papillary334 (8.5%) 17 (0-90) Micropapillary183 (4.6%) 25 (0-88) Apocrine12 (0.3%)27 (4-53) ER: ≥6.5 positive; PR: ≥5.5 positive; HER2: ≥11.5 positive, equivocal, <10.7 negative 0.3% were classified as DCIS, not otherwise specified

Correlation Pattern of Single Gene Expression The majority of samples (81.2%) were ER- and PR-positive. Very few (approximately 1%) of DCIS cases were found to be ER-negative and PR-positive. Approximately 8.9% of samples were ER-negative and 3.3% were both ER-negative and HER2- negative. The majority of samples (78.4%) were ER-positive and HER2-negative. A total of 8.4% of DCIS cases were ER-positive with concurrent elevated levels of HER2 expression. ER by PR ER by HER2 ER PR HER2