Genomic Testing in International Guidelines
Peter Kern, Mahdi Rezai, Christian Singer, Rainer Kimmig
European Medical Journal. 2013. November 2013: 68-74.

Personalizing the Treatment of Women with Early Breast Cancer: Highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer
Goldhirsch, E. P. Winer, A. S. Coates, R. D. Gelber, M. Piccart-Gebhart, B. Thürlimann,H.-J. Senn,and Panel members
2013. Ann Oncol. Sep 2013; 24(9): PMCID: PMC3755334: 2206–2223.

Gene Expression Profiling and Expanded Immunohistochemistry Tests to Guide the Use of Adjuvant Chemotherapy in Breast Cancer Management: A Systematic Review and Cost-Effectiveness Analysis.
S Ward, A Scope, R Rafia, A Pandor, S Harnan, P Evans and L Wyld
Health Technology Assessment 2013; Vol. 17: No. 44DOI: 10.3310/hta17440: 1-10.

Clinical Validation

A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer.
S Paik, S Shak, G Tang, C Kim, J Baker, M Cronin, FL Baehner, MG Walker, D Watson, T Park, W Hiller, ER Fisher, DL Wickerham, J Bryant, N Wolmark
N Engl J Med. 2004 Dec 30;351(27):2817-26.

Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer.
S Paik, G Tang, S Shak, C Kim, J Baker, W Kim, M Cronin, FL Baehner, D Watson, J Bryant, JP Costantino, C Geyer Jr., DL Wickerham, N Wolmark
J Clin Oncol. 2006 Aug 10;24(23):3726-34.

A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. 
LA Habel, S Shak, M Jacobs, A Capra, C Alexander, M Pho, J Baker, MG Walker, D Watson, J Hackett, N Blick, D Greenberg, L Fehrenbacher, B Langholz, CP Quesenberry
Breast Cancer Res. 2006;8(3):R25.

Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population.
Toi M, Iwata H, Yamanaka T, Masuda N, Ohno S, Nakamura S, Nakayama T, Kashiwaba M, Kamigaki S, Kuroi K; Japan Breast Cancer Research Group-Translational Research Group.
Cancer. 2010 Jul 1;116(13):3112-8.

Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study.
Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, Quinn E, Dunbier A, Baum M, Buzdar A, Howell A, Bugarini R, Baehner FL, Shak S.
J Clin Oncol. 2010 Apr 10;28(11):1829-34.

Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, estrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomized trial.
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh IT, Ravdin P, Bugarini R, Baehner FL, Davidson NE, Sledge GW, Winer EP, Hudis C, Ingle JN, Perez EA, Pritchard KI, Shepherd L, Gralow JR, Yoshizawa C, Allred DC, Osborne CK, Hayes DF; Breast Cancer Intergroup of North America.
Lancet Oncol. 2010 Jan;11(1):55-65.

Decision Impact

Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER1) node-negative breast cancer.
J. Albanell, A. Gonzalez, M. Ruiz-Borrego, et al.
Ann Oncol.

Impact of the 21-Gene Recurrence Score Assay Compared With Standard Clinicopathologic Guidelines in Adjuvant Therapy Selection for Node-Negative, Estrogen Receptor-Positive Breast Cancer.
Partin JF, Mamounas EP.
Annals of Surgical Oncology

The impact of the 21-gene recurrence score assay on decision making about adjuvant chemotherapy in early-stage estrogen-receptor-positive breast cancer in an oncology practice with a unified treatment policy.
Geffen DB, Abu-Ghanem S, Sion-Vardy N, Braunstein R, Tokar M, Ariad S, Delgado B, Bayme M, Koretz M.
Ann Oncol.

Physician Survey of the Effect of the 21-Gene Recurrence Score Assay Results on Treatment Recommendations for Patients With Lymph Node–Positive, Estrogen Receptor–Positive Breast Cancer
Ruth Oratz, MD, FACP, Benjamin Kim, MD, MPhil, Calvin Chao, MD, Stanley Skrzypczak, MS, Caron Ory, RN, MSN, Roberto Bugarini, DStat, and Michael Broder, MD, FACOG
Journal of Oncology Practice 2011.

Prospective Multicenter Study of the Impact of the 21-Gene Recurrence Score Assay on Medical Oncologist and Patient Adjuvant Breast Cancer Treatment Selection.
Shelly S. Lo,*Patricia B. Mumby, ­John Norton, ­Karen Rychlik, ­Jeffrey Smerage, ­Joseph Kash, ­Helen K. Chew, ­Ellen R. Gaynor, ­Daniel F. Hayes, ­Andrew Epstein, ­and Kathy S. Albain

Association Between the 21-Gene Recurrence Score Assay and Risk of Locoregional Recurrence in Node-Negative, Estrogen Receptor–Positive Breast Cancer: Results From NSABP B-14 and NSABP B-20. 
Eleftherios P. Mamounas,*­Gong Tang, ­Bernard Fisher, ­Soonmyung Paik, ­Steven Shak, ­Joseph P. Costantino, ­Drew Watson, ­Charles E. Geyer Jr, ­D. Lawrence Wickerham, ­and Norman Wolmark

The influence of a gene expression profile on breast cancer decisions.
Henry L, Stojadinovic A, Swain SM et al.
Journal of Surgical Oncology:319–323.

Does Oncotype DX recurrence score affect management of patients with early –stage breast cancer? 
Asad J, Jacobson A, Estabrook A et al.
Am J Manag Care. 2008;American Journal of Surgery:527–529.

Low Recurrence Score by the Oncotype DX Breast Cancer Assay Rarely Results in Recommendation for or Administration of Chemotherapy: A Pooled Analysis
P Hall, S Skrzypczak, G Palmer
Abstract #2601: Poster Session

Impact of a Commercial Reference Laboratory Test Recurrence Score on Decision Making in Early-Stage Breast Cancer
R Oratz, D Paul, AL Cohn, SM Sedlacek

Development and Clinical Utility of a 21-Gene Recurrence Score Prognostic Assay in Patients with Early Breast Cancer Treated with Tamoxifen
S Paik

A Retrospective Analysis of the Impact of Oncotype DX Low Recurrence Score Results on Treatment Decisions in a Single Academic Breast Cancer Center
H Liang, AM Brufsky, BB Lembersky, P Rastogi, VG Vogel
Abstract #2061 : Poster Session

Evaluation of Practice Patterns in the Treatment of Node-Negative, Hormone-Receptor Positive Breast Cancer Patients with the Use of the Oncotype DX Assay at the University of Pennsylvania
C Erb, KR Fox, M Patel, K Hook, A DeMichele, C Kaplan, S Domchek
Abstract #3082 : Poster Session

Prospective Multi-Center Study of the Impact of the 21-Gene Recurrence Score (RS) Assay on Medical Oncologist (MO) and Patient (PT) Adjuvant Breast Cancer (BC) Treatment Selection
SS Lo, J Norton, PB Mumby, J Smerage, J Kash, HK Chew, D Hayes, A Epstein, KS Albain
Abstract #577 : Poster Session

Roadmap for Developing and Validating Therapeutically Relevant Genomic Classifiers
R Simon
J Clin Oncol. 2005;23(29):7332-7341.

Impact of Oncotype DX™ on Decision Making in Breast Cancer Clinical Practice
R Oratz, D Paul, A Cohn, S Sedlacek
Abstract #2049 : Poster Session

Prospective Multi-Center Study of the Impact of the 21-Gene Recurrence Score Assay on Patient Satisfaction, Anxiety and Decisional Conflict for Adjuvant Breast Cancer Treatment Selection
PB Mumby, SS Lo, J Norton, J Smerage, K Joseph, HK Chew, D Hayes, KS Albain
Abstract #1092 : Poster Session

Neoadjuvant Treatment

Gene Expression Profiles in Paraffin-Embedded Core Biopsy Tissue Predict Response to Chemotherapy in Women with Locally Advanced Breast Cancer
L Gianni, M Zambetti, K Clark, J Baker, M Cronin, J Wu, G Mariani, J Rodriguez, M Carcangiu, D Watson, P Valagussa, R Rouzier, WF Symmans, JS Ross, GN Hortobagyi, L Pusztai, S Shak
23(29): 7265-7277.

Health Economics

Multigene Assays and Molecular Markers in Breast Cancer: Systematic Review of Health Economic Analyses.
Roman Rouzier, Paolo Pronzato, Elisabeth Chéreau, Josh Carlso, Barnaby Hunt, William J. Valentine
Springer 2013, Breast Cancer Res Treat DOI 10.1007/s10549-013-2559-1: 1.

Is the 21-gene recurrence score a cost-effective assay in endocrine-sensitive node-negative breast cancer?
Lamond NW, Skedgel C, Younis T
Expert Review of Pharmacoeconomics & Outcomes Research, April 2013, Vol. 13, No. 2: Pages 243-250 (doi:10.1586/erp.13.4) .

Impact of a 21-Gene RT-PCR Assay on Treatment Decisions in Early-Stage Breast Cancer, An Economic Analysis Based on Prognostic and Predictive Validation Studies
GH Lyman, LE Cosler, NM Kuderer, J Hornberger
109(6): 1011-1018.

Economic Analysis of Targeting Chemotherapy Using a 21-Gene RT-PCR Assay in Lymph Node-Negative, Estrogen Receptor-Positive, Early-Stage Breast Cancer
J Hornberger, LE Cosler, GH Lyman
11(5): 313-324.

Cost-Effectiveness of 21-Gene Assay in Node-Positive, Early-Stage Breast Cancer
Burton F. Vanderlaan, MD; Michael S. Broder, MD; Eunice Y. Chang, PhD; Ruth Oratz, MD, FACP; and Tanya G. K. Bentley, PhD
17(7): 455-464.

Platform Technology

Measurement of Gene Expression in Archival Paraffin-Embedded Tissues
M Cronin, M Pho, D Dutta, JC Stephans, S Shak, MC Kiefer, JM Esteban, JB Baker
164(1): 35-42.

Biomarker discovery for colon cancer using a 761 gene RT-PCR assay
Kim M Clark-Langone*1, Jenny Y Wu1, Chithra Sangli1, Angela Chen1,James L Snable1, Anhthu Nguyen1, James R Hackett1,Joffre Baker1,Greg Yothers2, Chungyeul Kim2 and Maureen T Cronin1
8(279): 1471-2164-8-279.

Analytical Validation of the Oncotype DX Genomic Diagnostic Test Recurrence Prognosis and Therapeutic Response Prediction in Node-Negative, Estrogen Receptor-Positive Breast Cancer
M Cronin, C Sangli, ML Liu, M Pho, D Dutta, A Nguyen, J Jeong, J Wu, KC Langone, D Watson
53(6): 1084-1091.

Assay Development

Tumor Gene Expression and Prognosis in Breast Cancer Patients with 10 or More Positive Lymph Nodes
MA Cobleigh, B Tabesh, P Bitterman, J Baker, M Cronin, ML Liu, R Borchik, JM Mosquera, MG Walker, S Shak
11(24 Pt 1): 8623-8631.

Prognostic Role of a Multigene Reverse Transcriptase-PCR Assay in Patients with Node-Negative Breast Cancer Not Receiving Adjuvant Systemic Therapy
FJ Esteva, AA Sahin, M Cristofanilli, K Coombes, SJ Lee, J Baker, M Cronin, MG Walker, D Watson, S Shak, GN Hortobagyi
11(9): 3315-3319.

Development and Clinical Utility of a 21-Gene Recurrence Score Prognostic Assay in Patients with Early Breast Cancer Treated with Tamoxifen
S Paik
12(6): 631-635.

Related Articles

Comparison of the prognostic and predictive utilities of the 21-gene Recurrence Score assay and Adjuvant! for women with node-negative, ER-positive breast cancer: results from NSABP B-14 and NSABP B-20
Gong Tang, Steven Shak, Soonmyung Paik, Stewart J. Anderson, Joseph P. Costantino, Charles E. Geyer Jr., Eleftherios P. Mamounas, D. Lawrence Wickerham, Norman Wolmark
2010. Breast Cancer Research Treatment 2010.

Roadmap for Developing and Validating Therapeutically Relevant Genomic Classifiers
R Simon
23(29): 7332-7341.

Problems and Solutions in the Evaluation of Hormone Receptors in Breast Cancer
DC Allred
25(15): 2433-2435.

Estrogen- and Progesterone-Receptor Status in ECOG 2197: Comparison of Immunohistochemistry by Local and Central Laboratories and Quantitative Reverse Transcription Polymerase Chain Reaction by Central Laboratory
Sunil S. Badve, Frederick L. Baehner, Robert P. Gray, Barrett H. Childs, Tara Maddala, Mei-Lan Liu, Steve C. Rowley, Steven Shak, Edith D. Perez, Lawrence J. Shulman, Silvana Martino, Nancy E. Davidson, George W. Sledge, Lori J. Goldstein, and Joseph A. Sparano
26(15): 2473-2481.

Development of the 21-Gene Assay and Its Application in Clinical Practice and Clinical Trials
JA Sparano, S Paik
26: 721-728.

Development and Clinical Utility of a 21-Gene Recurrence Score Prognostic Assay in Patients with Early Breast Cancer Treated with Tamoxifen
S Paik
12(6): 631-635.

American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer
L Harris, H Fritsche, R Mennel, L Norton, P Ravdin, S Taube, MR Somerfield, DF Hayes, RC Bast Jr.
25(33): 5287-5312.

Adjuvant Chemotherapy for Patients with Estrogen Receptor-Positive Breast Cancer
HJ Burstein, S Paik, P Ravdin, K Albain

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