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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; 2817-2826.

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; R25.

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; 24(23):3726-3734.

Prediction of Risk of Distant Recurrence Using the 21-Gene Recurrence Score in Node-Negative and Node-Positive Postmenopausal Breast Cancer Patients Treated with Anastrozole or Tamoxifen: A TransATAC Study
M Dowsett, J Cuzick, C Wale, J Forbes, EA Mallon, J Salter, E Quinn, A Dunbier, M Baum, A Buzdar, A Howell, R Bugarini, FL Baehner FL, Shak S.
J Clin Oncol. 2010; 28(11):1829-1834.

Prognostic and Predictive Value of the 21-Gene Recurrence Score Assay in Postmenopausal, Node-Positive, Estrogen Receptor-Positive Breast Cancer
K Albain, W Barlow, S Shak, G Hortobagyi, R Livingston, I-T Yeh, P Ravdin, R Bugarini, FL Baehner, NE Davidson, GW Sledge, E Winer, C Hudis, J Ingle, E Perez, K Pritchard, L Shepherd, J Gralow, C Yoshizawa, D Allred, C Osborne, D Hayes
Lancet Oncology. 2010; 11(1):55-65.

Decision Impact

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.
Oratz R, Kim B, Chao C, Skrzypczak S, Ory C, Bugarini R, Broder M.
J Oncol Pract. 2011; 7(2):94-9.

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
J Clin Oncol. 2010;

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
J Oncol Pract. 2007; 3(4):182-186.

Prospective Multicenter Study of the Impact of the 21-Gene Recurrence Score Assay on Medical Oncologist and Patient Adjuvant Breast Cancer Treatment Selection.
SS Lo, PB Mumby, J Norton, K Rychlik, J Smerage, J Kash, HK Chew, ER Gaynor, DF Hayes, A Epstein, KS Albain.
J Clin Oncol. 2010; 28(10):1671-1676.

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
J Oncol Pract. 2011; Journal of Oncology Practice 2011.

Does Oncotype DX recurrence score affect management of patients with early–stage breast cancer?
Asad J, Jacobson A, Estabrook A et al.
The American Journal of Surgery. 2008; 196:527-529.

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 Oncology. 2011;

The influence of a gene expression profile on breast cancer decisions
Henry L, Stojadinovic A, Swain SM et al.
The American Journal of Surgery. 2009; 99:319-323.

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
J Clin Oncol. 2005; 23(29):7265-7277.

Health Economics

US Insurance Program's Experience With a Multigene Assay for Early-Stage Breast Cancer
Hornberger J., Chien R., Krebs K., and Hochheiser L.
J Oncol Pract. 2011; e38s-e45s.

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
Am J Manag Care. 2011; 17(7):455-464.

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
Am J Manag Care. 2005; 11(5):313-324.

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
Cancer. 2007; 109(6):1011-1018.

Platform Technology

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
Clin Chem. 2007; 53(6):1084-1091.

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
2007; 8(279):1471-2164-8-279.

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
Am J Pathol. 2004; 164(1):35-42.

Assay Development

Development and Clinical Utility of a 21-Gene Recurrence Score Prognostic Assay in Patients with Early Breast Cancer Treated with Tamoxifen
S Paik
Oncologist. 2007; 12(6):631-635.

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
Clin Cancer Res. 2005; 11(9):3315-3319.

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
Clin Cancer Res. 2005; 11(24 Pt 1):8623-8631.

Additional Oncotype DX Assay-Related Articles

Estrogen Receptor (ESR1) mRNA Expression and Benefit From Tamoxifen in the Treatment and Prevention of Estrogen Receptor–Positive Breast Cancer
Kim C., Tang G., Pogue-Geile KL., Costantino JP., Baehner FL., Baker J., Cronin MT., Watson D., Shak S., Bohn OL., Fumagalli D., Taniyama Y., Lee A., Reilly ML., Vogel VG., McCaskill-Stevens W., Ford LG., Geyer Jr. CE., Wickerham DL., Wolmark N. and Paik S.
J Clin Oncol. 2011; 4160-4167.

Strategies for Subtypes—Dealing with the Diversity of Breast Cancer: Highlights of the St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2011
A. Goldhirsch, W. C. Wood, A. S. Coates, R. D. Gelber, B. Thürliman, H.-J. Senn & Panel members
Annals of Oncology. 2011; 22:1736-1747.

Human Epidermal Growth Factor Receptor 2 Assessment in a Case-Control Study: Comparison of Fluorescence In Situ Hybridization and Quantitative Reverse Transcription Polymerase Chain Reaction Performed by Central Laboratories
Frederick L. Baehner, Ninah Achacoso, Tara Maddala, Steve Shak, Charles P. Quesenberry, Jr, Lynn C. Goldstein, Allen M. Gown, and Laurel A. Habel
J Clin Oncol. 2010; 4300-4306.

Adjuvant Chemotherapy for Patients with Estrogen Receptor-Positive Breast Cancer
HJ Burstein, S Paik, P Ravdin, K Albain
ASCO Educational Book. 2006;

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.
J Clin Oncol. 2007; 25(33):5287-5312.

Development of the 21-Gene Assay and Its Application in Clinical Practice and Clinical Trials
JA Sparano, S Paik
J Clin Oncol. 2008; 26:721-728.

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
SS Badve, FL Baehner, RP Gray, BH Childs, T Maddala, ML Liu, SC Rowley, S Shak, ED Perez, LJ Shulman, S Martino, NE Davidson, GW Sledge, LJ Goldstein, JA Sparano
J Clin Oncol. 2008; 26(15):2473-2481.

Problems and Solutions in the Evaluation of Hormone Receptors in Breast Cancer
DC Allred
J Clin Oncol. 2008; 25(15):2433-2435.

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

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
Breast Cancer Res Treat. 2010; Breast Cancer Research Treatment 2010.

Scientific Presentations, Posters & Abstracts

2011 SABCS - San Antonio, TX.

Abstract #OD06-02
Cost-Effectiveness Evaluation of the Oncotype DX Breast Cancer Assay in Clinical Practice in the UK
Holt SDH, Bennett H, Bertelli G, Valentine WJ, Phillips CJ. Prince Philip Hospital, Llanelli, United Kingdom; Cardiff Research Consortium, Cardiff, United Kingdom; Singleton Hospital, Swansea, United Kingdom; Ossian Health Economics and Communications, Basel, Switzerland; Swansea University, Swansea, United Kingdom.
2011;

Abstract #P1-07-11
Consistency and Control in Clinical Assay Technology over Time: The Oncotype DX Recurrence Score and Assessment of Single Gene Expression Levels
Baehner FL, Butler SM, Anderson JM, Ballard J, Tan V, Shak S. Genomic Health, Inc., Redwood City, CA; UCSF, San Francisco, CA.
2011;

Abstract #P1-07-22
A Venezuelan Study of Breast Cancer Estrogen Receptor, Progesterone Receptor and HER2 Receptor Expression by the Standard Method, Immunohistochemistry (IHC), Compared to a New Method, Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)
Marin C-EM, Ramirez AC, Baehner FL, Yoshizawa C, Acosta MM. Fundacion BADAN, Caracas, Miranda, Venezuela; Genomic Health, Redwood City, CA.
2011;

Abstract #P1-10-04
Cost-Utility of the 21-Gene Breast Cancer Assay (Oncotype DX) in the Irish Healthcare Setting
Lacey L, Chien R, Hornberger J. Lacey Solutions Ltd, South Strand, Skerries, County Dublin, Ireland; Cedar Associates LLC, Menlo Park, CA; Columbia University, New York, NY; Stanford University, Stanford, CA.
2011;

Abstract #P1-10-05
Is the 21-Gene Breast Cancer Test (Oncotype DX) Cost-Effective?
Pronzato P, Plun-Favreau J. Istituto Naz.le Ricerca Cancro, Genova, Italy; Genomic Health International Sàrl, Geneva, Switzerland.
2011;

Abstract #P1-10-06
Economic Analysis of Chemotherapy Costs for Adjuvant Therapy in Breast Cancer in France
Chereau E, Vataire A-L, Laas E, Genin A-S, Aballéa S, Rouzier R. Tenon - APHP, Paris, France; Creativ-Ceutical, Paris, France.
2011;

Abstract #P2-12-26
Impact of the Recurrence Score on Adjuvant Decision-Making in ER-Positive Early Breast Cancer - Results of a Large Prospective Multicentre Decision Impact Study in Node Negative and Node Positive Disease
Rezai M, Eiermann W, Kümmel S, Kühn T, Warm M, Friedrichs K, Schneeweiss A, Markmann S, Eggemann H, Hilfrich J, Jackisch C, Witzel I, Eidtmann H, Kaufmann M, Blohmer JU. Luisenkrankenhaus, Düsseldorf, Germany; Rotkreuzklinikum, München, Germany; Kliniken Essen-Mitte, Essen, Germany; Klinikum Esslingen, Esslingen, Germany; Krankenhaus Holweide, Köln, Germany; Brustzentrum, Hamburg, Germany; Universitätsklinikum, Heidelberg, Germany; Universitätsklinikum, Rostock, Germany; Universitätsklinikum, Magdeburg, Germany; Eilenriedeklinik, Hannover, Germany; Klinikum Offenbach, Offenbach, Germany; Universitätsklinikum Eppendorf, Hamburg, Germany; Universitätsklinikum, Kiel, Germany; Univesitätsklinikum, Frankfurt, Germany; Sankt Gertrauden-Krankenhaus, Berlin, Germany.
2011;

Abstract #P2-12-26
Comparison of Oncotype DX Recurrence Scores between Surgical and Core Biopsy Specimens in Breast Cancer Patients
Stull TS, Goodwin MC, Anderson JM, Baehner FL, Sing AP, Yoshizawa CN, Barrio AV, Frazier TG. The Bryn Mawr Hospital, Bryn Mawr, PA; Genomic Health, Inc, Redwood City, CA.
2011;

Abstract #P4-09-18
Australian Decision Impact Study: The Impact of Oncotype DX Recurrence Score (RS) on Adjuvant Treatment Decisions in Hormone Receptor Positive (HR+), Node Negative (N0) and Node Positive (N+) Early Stage Breast Cancer (ESBC) in the Multidisciplinary Clinic (MDC)
de Boer RH, Baker C, Speakman D, Mann B. Royal Melbourne Hospital, Melbourne, Victoria, Australia; Austin Hospital, Melbourne, Victoria, Australia; Peter MacCallum Cancer Institue, Melbourne, Victoria, Australia; Royal Melbourne and Royal Women's Hospital, Melbourne, Victoria, Australia.
2011;

Abstract #P5-13-09
Correlation of Oncotype DX Recurrence Scores with Pathologic Response Following Neoadjuvant Ixabepilone and Cyclophosphamide in Patients with HER2-Negative Breast Cancer: A Sarah Cannon Research Institute Phase II Trial
Yardley DA, Peacock NW, Hendricks C, Huh SY, Ketchum S, Chao C, Yoshizawa C, Burris III HA, Hainsworth JD. Sarah Cannon Research Institute, Nashville, TN; Tennessee Oncology, PLLC, Nashville, TN; Center for Cancer and Blood Disorders, Bethesda, MD; Providence Medical Group, Terre Haute, IN; Mercy Hospital, Portland, ME; Genomic Health, Redwood City, CA.
2011;

Abstract #P5-14-03
Genomic Comparison of Paired Primary Breast Carcinomas and Macrometastatic Lymph Node Metastases Using Quantitative RT-PCR by Oncotype DX: Assessment of the Recurrence Score and Quantitative Single Genes
Boolbol SK, Kirstein L, Harshan M, Klein P, Cohen J-M, Chadha M, Baehner FL, Malamud SC. Beth Israel Medical Center, New York, NY; Genomic Health Inc., Redwood City, CA
2011;

Abstract #P5-14-26
Results from a Prospective Clinical Study on the Impact of Oncotype DX on Adjuvant Treatment Decision Making in a Cohort of 142 UK Patients
Holt S, Bertelli G, Brinkworth E, Durrani S, Jones S, Khawaja S, Laggner U, Moe M, Pudney D, Pitcher S, Rolles M, Sharaiha Y, Whelan S. Prince Philip Hospital, Llanelli, Carmarthenshire, United Kingdom; Singleton Hospital, Swansea, West Glamorgan, United Kingdom; Bronglais Hospital, Aberystwyth, Ceredigion, United Kingdom
2011;

Abstract #P5-18-03
First Interim Toxicity Analysis of the Randomized Phase III WSG Plan B Trial Comparing 4xEC-4xDoc Versus 6xTC in Breast Cancer Patients with HER2 Negative Breast Cancer (BC)
Nitz U, Gluz O, Krepe H, Liedtke B, Aktas B, Henschen S, Pollmanns A, Krabisch P, Zuna I, Shak S, Thomsseen C, Harbeck N. West German Study Group, Moenchengladbach, Germany; Breast Centre Niederrhein/Bethesda Hospital, Moenchengladbach, Germany; Bethesda Hospital, Wuppertal, Germany; Medizinishce Hochschule, Hannover, Germany; Evangelical Hospital, Bergisch Gladbach, Germany; University Hospital, Essen, Germany; Johanniter Hospital, Stendal, Germany; Evangelical Hospital, Oberhausen, Germany; City Hospital Chemnitz, Chemnitz, Germany; Genomic Health Inc, Redwood City, Germany; University Hospital Halle/Saale, Halle/Saale, Germany; University Hospital Cologne, Cologne, Germany.
2011;

Abstract #PD03-09
Breast Cancer Recurrence Risk Probed by Whole Transcriptome Next Generation Sequencing in 136 Patients
Baker J, Liu M-L, Crager M, Stephans J, Pho M, Jeong J, Scott A, Ambannavar R, Morlan J, Pelham R, Qu K, Mena RR, Esteban J, Collin F, Sinicropi D. Genomic Health Inc., Redwood City, CA; Providence St. Joseph Medical Center, Burbank, CA.
2011;

Abstract #S4-06
A quantitative multigene RT-PCR assay for predicting recurrence risk after surgical excision alone without irradiation for ductal carcinoma in situ (DCIS): A prospective validation study of the DCIS score from ECOG E5194
Solin LJ, Gray R, Baehner FL, Butler S, Badve S, Yoshizawa C, Shak S, Hughes L, Sledge G, Davidson N, Perez EA, Ingle J, Sparano JA, Wood W. Albert Einstein Medical Center, Philadelphia, PA; Eastern Cooperative Oncology Group, Boston, MA; Genomic Health, Inc., Redwood City, CA; Indiana University, Indianapolis, IN; The Hope Center, Cartersville, GA; University of Pittsburgh, Pittsburgh, PA; Mayo Clinic Jacksonville, Jacksonville, FL; Mayo Clinic Rochester, Rochester, MN; Albert Einstein College of Medicine, Bronx, NY; Emory University, Atlanta, GA.
2011;

Abstract #S4-3
Prospective comparison of risk assessment tools in early breast cancer (recurrence score, uPA/PAI-1, central grade, and luminal subtypes): Final correlation analysis from the phase III WSG-Plan B trial
Gluz O, Kreipe H, Degenhardt T, Kates R, Christgen M, Liedtke C, Shak S, Clemens M, Markmann S, Uleer C, Augustin D, Thomssen C, Nitz U, Harbeck N. West German Study Group, Moenchengladbach, Germany; Medizinische Hochschule, Hannover, Germany; University of Muenster, Muenster, Germany; Genomic Health Inc, Redwood City; Klinikum Mutterhaus, Trier, Germany; Klinikum Suedstadt, Rostock, Germany; Gynecology Practice, Hildesheim, Germany; Klinikum Deggendorf, Deggendorf, Germany; University of Halle/Saale, Halle/Saale, Germany; Bethesda Clinics, Moenchengladbach, Germany; University of Cologne, Cologne, Germany.
2011;

2011 ASCO - Chicago, IL.

Abstract #558
A study of the Recurrence Score by the 21-gene signature assay as a predictor of clinical response to neoadjuvant exemestane for 24 weeks in estrogen-receptor-positive breast cancer.
N. Masuda, M. Toi, T. Ueno, T. Yamanaka, S. Saji, K. Kuroi, N. Sato, H. Takei, Y. Yamamoto, S. Ohno, H. Yamashita, K. Hisamatsu, K. Aogi, H. Iwata, S. Saji, H. Sasano; National Hospital Organization Osaka National
2011;

Abstract #10594
Prospective comparison of Recurrence Score, uPA/PAI-1, central grade and molecular classification in early breast cancer: Interim results from the WSG-Plan B trial.
T. Degenhardt, O. Gluz, H. H. Kreipe, R. E. Kates, C. Liedtke, S. Shak, M. R. Clemens, D. Augustin, U. Nitz, N. Harbeck, on behalf of the Plan B investigators; University Hospital Cologne, Cologne, Germany; West German Study Group and Evangelical Hospital Bethesda, Wuppertal, Germany; Hannover Medical School, Hannover, Germany; REK Consulting, Otterfing, Germany; West German Study Group and University of Muenster, Muenster, Germany; Genomic Health, Redwood City, CA; Klinikum Mutterhaus, Trier, Germany; Klinikum Deggendorf, Deggendorf, Germany; West German Study Group and Evangelical Hospital Bethesda, Moenchengladbach, Germany; West German Study Group and University of Cologne, Cologne, Germany
2011;

Abstract #1066
Ixabepilone and cyclophosphamide as neoadjuvant therapy in HER2-negative breast cancer with exploratory Oncotype DX assessments: A Sarah Cannon Research Institute phase II trial.
N. W. Peacock, D. A. Yardley, C. B. Hendricks, S. Y. Huh, S. L. Ketchum, C. Chao, C. Yoshizawa, M. Shastry, B. Strike, H. A. Burris, J. D. Hainsworth; Tennessee Oncology, Nashville, TN; Sarah Cannon Research Institute, Nashville, TN; National Capital Clinical Research Consortium, Bethesda, MD; Coleman Cancer Center, Terre Haute, IN; Mercy Hospital, Portland, ME; Genomic Health, Redwood City, CA
2011;

Abstract #6111
A cost benefit analysis of the 21-gene breast cancer assay within a Canadian health care system.
S. Hassan, N. Mittmann; HOPE Research Centre, Sunnybrook Health Sciences Centre, Toronto, ON, Canada
2011;

Abstract #625
Evaluating utilization characteristics for the Oncotype DX Recurrence Score in early-stage breast cancer.
C. Chen, D. A. Patt, D. R. Kazzaz, J. Shankleton, M. T. Forsyth, R. Ganesh; US Oncology Healthcare Informatics, The Woodlands, TX; US Oncology, The Woodlands, TX; US Oncology Inc., The Woodlands, TX; US Oncology Inc., Houston, TX
2011;

Abstract #632
Evaluation of Recurrence Score and traditional clinicopathologic assessments in a large ER-positive, lymph node-negative patient cohort.
N. Liebermann, F. L. Baehner, L. Soussan-Gutman, S. Klang, C. Yoshizawa, S. Shak, N. Siegelmann-Danieli; Clalit Health Services, Tel Aviv, Israel; University of California, San Francisco, San Francisco, CA; Teva Pharmaceutical Industries, Netanya, Israel; Genomic Health, Redwood City, CA; Maccabi Health Organization, Tel Aviv, Israel
2011;

Abstract #e10005
Evaluation of relation between Oncotype DX Recurrence Score and adjuvant chemotherapy administration.
D. R. Kazzaz, C. Chen, J. Shankleton, M. T. Forsyth, R. Ganesh, M. Sims, D. A. Patt; US Oncology Inc., The Woodlands, TX; US Oncology Healthcare Informatics, The Woodlands, TX; US Oncology Inc., Houston, TX; University of Texas, Austin, TX; US Oncology, The Woodlands, TX
2011;

2011 SG-BCC - 12th International St.Gallen Breast Cancer Conference St.Gallen, Switzerland

Abstract #P196
Results from a prospective clinical study on the impact of Oncotype DX on adjuvant treatment decision and risk classification by Nottingham prognostic index (NPI) and recurrence score (RS)
S.D.H. Holt G. Bertelli, D. Pudney, M. Rolles, M. Moe, E. Brinkworth, S. Wheelan, S. Khawaja, S. Pitcher, Y. Sharaiha Breast Surgery, Prince Philip Hospital, Llanelli, Oncology Department, Singleton Hospital, Swansea United Kingdom
2011;

Abstract #P197
Oncotype Dx; St. Gallen risk group and Adjuvant!online nomogram as prognostic predictor for lymph nodes positive breast cancer patients
L. Leitzin N. Sikorsky, M. Leviov, E. Grikstass, M. Steiner Oncology Department, Lynn Medical Center, Haifa Israel
2011;

Abstract #P198
Prospective trans-GEICAM study of the impact of the 21-gene recurrence score assay and traditional clinico-pathological factors on clinical decision making in women with estrogen receptor-positive, HER2-negative, node-negative breast cancerand transGEICAM 2010-01 study investigators
J. Albanell R. Colomer, M. Ruiz-Borrego, E. Alba, J.A. García Saenz, M. Martin, I. Tusquets, F. Rojo, I. Faull, A. Lluch Hospital del Mar, Barcelona, MD Anderson, Madrid, Hospital Virgen del Rocío, Sevilla, Hospital Clínico, Málaga, Hospital Clínico, Hospital Gregorio Marañ
2011;

Abstract #P200
Impact of the 21-gene recurrence score assay on treatment decision in early breast cancer (EBC) patients with favourable prognostic factors
C. Markopoulos Athens University Medical School, Athens Greece
2011;

Abstract #P201
Meta-analysis of the decision impact of the 21-gene breast cancer Recurrence Score® in clinical practice
J.C. Hornberger R. Chien School of Medicine, Stanford University, Stanford, Cedar Associates LLC, Menlo Park United States
2011;

Abstract #P206
German multicentre decision impact study of Oncotype DX recurrence score (RS) on adjuvant treatment in estrogen receptor positive (ER+) node negative (N0) and node positive (N+) early breast cancer
J.U. Blohmer T. Kühn, M. Rezai, S. Kümmel, M. Warm, H. Eggemann, K. Friedrichs, W. Eiermann St. Gertraudenkrankenhaus, Berlin, Klinikum, Esslingen, Luisenkrankenhaus, Düsseldorf, Kliniken Essen Mitte, Essen, Krankenhaus Holweide, Köln, Universitätskrankenhaus, Magdebu
2011;

Abstract #P209
Evaluating conventional pathological factors against the standardized 21-gene signature for hormone receptor positive breast cancer patients
T. Onoda H. Yamauchi, H. Yagata, K. Tsugawa, K. Suzuki, S. Nakamura Breast Surgical Oncology, St. Luke's International Hospital, Tokyo, Breast Surgery, Yokohama Asahi Central General Hospital, Breast and Endocrine Surgery, St. Marianna School of Medicine, Kanagawa, Pa
2011;

Abstract #P215A
Cost-benefit analysis of a 21-gene recurrence score for early stage breast cancer in Singapore
G. de Lima Lopes R. Chien, J.C. Hornberger Medical Oncology, International Medical Centre Singapore, Singapore Singapore; Cedar Associates LLC, Menlo Park, School of Medicine, Stanford University, Stanford United States
2011;

Abstract #P215B
Evaluation of the cost-effectiveness of Oncotype-DX® multigene assay in Hungary
B. Madaras P. Rózsa, Z. Gerencsér, T. Radovics, I. Láng, Z. Nagy, Z. Horváth Chemotherapy B and Clinical Pharmacology, National Institute of Oncology, MediConcept Kft, Semmelweis Medical University, Faculty of Medicine, Med Gen-Sol Kft, Budapest Hungary
2011;

2010 SABCS---San Antonio, TX

Abstract #P2-09-05
Risk Group Selection in Primary Breast Cancer According to ASCO Recommended Biomarkers Oncotype DX® and uPA/PAI-1: First Experience from Prospective Multicenter WSG Plan B Trial
Degenhardt T, Gluz O, Thomssen C, Vetter M, Kates R, Warm M, Shak S, Augustin D, Kusche M, Untch M, Paepke S, Uleer C, Dünnebacke J, Nitz U, Harbeck N, on Behalf of WSG/AGO PlanB investigators. University Hospital of Cologne/Breast Cancer Research Program, Germany; West German Study Group/Bethesda Wuppertal, Moenchengladbach, Germany; University Hospital of Gynecology and Obstetrics, Halle, Germany; West German Study Group, Otterfing, Germany; Genomic Health, Inc., Redwood City; Breast Center Hospital Deggendorf, Deggendorf, Germany; Marienhospital, Aachen, Germany; Breast Center Helios-Hospital Berlin-Buch, Berlin, Germany; Breast Center Technical University of Munich, Germany; Onkol. Praxis, Hildesheim, Germany; Kath. Hospital Koblenz/Breast Center, Koblenz, Germany; Breast Center Niederrhein, Bethesda Hospital, Moenchengladbach, Germany.
2010;

Abstract #P2-09-06
Meta-Analysis of the Decision Impact of the 21-Gene Breast Cancer Recurrence Score in Clinical Practice
Hornberger J, Chien R. Stanford University, CA; Cedar Associates LLC, Menlo Park, CA.
2010;

Abstract #P3-10-01
Quantitative Gene Expression Analysis in a Large Cohort of Estrogen-Receptor Positive Breast Cancers: Characterization of the Tumor Profiles in Younger Patients (≤ 40 yrs) and in Older Patients (≥70 yrs)
Shak S, Baehner FL, Stein M, Chen I, Yoshizawa C, Watson D, Swain SM. Genomic Health, Inc, Redwood City, CA; Young Survival Coalition, New York, NY; Washington Hospital Center, Washington DC.
2010;

Abstract #P3-10-12
Pilot Phase of the Randomized PlanB Trial: Prospective Comparison of Molecular Classification, Oncotype DX® and Clinical-Pathological Characteristics in Hormone-Receptor (HR) Positive Primary Breast Cancer
Gluz O, Kreipe H, Christgen M, Salem M, Clemens M, Markmann S, Liedtke B, Barinoff J, Aktas B, Henschen S, Lübbe K, Shak S, Baehner R, Liedtke C, Nitz U, Harbeck N, on Behalf of the WSG/AGO Plan B Investigators. West German Study Group/Bethesda Wuppertal, Moenchengladbach, Germany; University of Hannover, Germany; University of Cologne, Dept. OB&GYN, Breast Centre, Germany; Klinikum Mutterhaus der Borromaeerinnen, Trier, Germany; University Hospital Rostock, Germany; Ev. Hospital, Bergisch Gladbach, Germany; Dr. Horst-Schmidt Hospital, Wiesbaden, Germany; University Hospital Essen, Germany; Johanniter Hospital, Stendal, Germany; University Hospital Muenster, Germany; Hospital Henriettenstiftung, Dept. OB&GYN, Hannover, Germany; Breast Center Niederrhein, Bethesda Hospital, Moenchengladbach, Germany; Genomic Health, Inc., Redwood City.
2010;

Abstract #P3-10-13
Prognostic Value of Genomic Analysis after Neoadjuvant Chemotherapy for Breast Cancer
Mayer EL, Shak S, Miller K, Rugo H, Carey L, Ryabin N, Pomeroy C, Yoshizawa C, Winer EP, Burstein HJ. Dana-Farber Cancer Institute, Boston, MA; Genomic Health, Inc, Redwood City, CA; Indiana University Simon Cancer Center, Indianapolis; University of California San Francisco, Helen Diller Family Comprehensive Cancer Center; University of North Carolina, Lineberger Comprehensive Cancer Center, Chapel Hill.
2010;

Abstract #P3-10-15
Quantitative Gene Expression by RT-PCR in Classic and Variant Forms of Lobular Carcinoma in Estrogen Receptor Positive Invasive Breast Cancer
Anderson JM, Yoshizawa C, Winer EP, Watson D, Millward C, Tan V, Shak S, Baehner FL. Genomic Health, Redwood City, CA; Dana-Farber Cancer Institute, Boston, MA; University of California, San Francisco.
2010;

2010 ASCO - Chicago, IL.

Abstract #3097
Association of vorinostat with decrease in gene expression of proliferation-related genes in tumors from women with newly diagnosed breast cancer.
V. Stearns, L. K. Jacobs, T. N. Tsangaris, Z. Cheng, S. Slater, M. J. Fackler, C. Chao, R. Bugarini, E. Gabrielson, N.E. Davidson; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, MD; Johns Hopkins School of Medicine, Baltimore, MD; Anne Arundel Medical Center, Annapolis, MD; Genomic Health, Redwood City, CA; University of Pittsburgh Cancer Institute, and University of Pittsburgh Medical Center Cancer Center, Pittsburgh, PA
2010;

Abstract #511
Potential biologic causes of the racial survival disparity in adjuvant trials of ER-positive breast cancer.
K. S. Albain, W. E. Barlow, S. Shak, G. N. Hortobagyi, D. F. Hayes, for The Breast Cancer Intergroup of North America; Loyola University Medical Center, Maywood, IL; Cancer Research and Biostatistics, Seattle, WA; Genomic Health, Redwood City, CA; University of Texas M. D. Anderson Cancer Center, Houston, TX; University of Michigan Medical Center, Ann Arbor, MI
2010;

Abstract #6075
The recurrence score and chemotherapy treatment in node-positive, ER+ early-stage breast cancer patients in Israel.
S. Klang, N. Liebermann, S. Rizel, N. Ben-Baruch, S. Merling, L. Soussan-Gutman, R. Bugarini, C. Chao, S. Shak; Clalit Health Services, Tel Aviv, Israel; Rabin Medical Center, Petah Tikva, Israel; Kaplan Medical Center, Rehovot, Israel; Teva Pharmaceutical Industries, Netanya, Israel; Genomic Health, Redwood City, CA
2010;

Abstract #e11077
Effect of 21-gene recurrence score results on treatment recommendations in patients age 65 and older with lymph node-positive, estrogen receptor-positive breast cancer.
R. Oratz, C. Chao, S. Skrzypczak, C. Ory, M. Broder; New York University School of Medicine, New York, NY; Genomic Health, Redwood City, CA; Partnership for Health Analytic Research, Beverly Hills, CA
2010;

2009 United States and Canadian Academy of Pathology (USCAP) Annual Meeting Boston, MA

Abstract # 1421
HER2 Concordance between Central Laboratory Immunohistochemistry, FISH and Quantitative RT-PCR in Intergroup Trial E2197
Baehner FL, Gray R, Maddala T, Childs B, Rowley S, Shak S, Davidson NE, Sledge GW, Goldstein LJ, Sparano JA, Badve S
2009;

Abstract # 1574
Biopsy Cavities in Breast Cancer Specimens: Impact on Quantitative RT-PCR Gene Expression Profiles and Recurrence Risk Assessment
FL Baehner, C Quale, C Pomeroy, D Cherbavaz, S Shak.
2009;

Abstract # 2285
ER and PR Assessment by Central IHC: Examination and Comparison of Percent Positive Cells and Nuclear Staining Intensity in ECOG Breast Cancer Study 2197
S Badve, R Gray, B Childs, T Maddala, M Liu, S Rowley, N Davidson, S Shak, LJ Goldstein, GW Sledge, JA Sparano, FL Baehner
2009;

2009 SABCS---San Antonio, TX

Abstract #112
Prediction of 10-Year Chemotherapy Benefit and Breast Cancer-Specific Survival by the 21-Gene Recurrence Score (RS) Assay in Node-Positive, ER-Positive Breast Cancer – An Update of SWOG-8814 (INT0100).
Albain KS, Barlow WE, Shak S, Hortobagyi GN, Livingston RB, Yeh I-T, 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
2009;

Abstract #2031
Effect of 21-Gene Recurrence Score Results on Treatment Recommendations in Patients with Lymph Node-Positive, Estrogen Receptor-Positive Breast Cancer
Oratz R, Chao C, Skrzypczak S, Kim B, Broder M New York University School of Medicine, New York, NY; Genomic Health, Inc., Redwood City, CA; David Geffen School of Medicine at UCLA, Los Angeles, CA; Pardee RAND Graduate School, RAND Corporation, Santa Monica, CA; Partnership for Health Analytic Research, Beverly Hills, CA
2009;

Abstract #5165
Gene Expression Profiling of Phenotypically-Defined Hormone-Receptor Positive Breast Cancer: Evidence for Increased Transcriptional Activity of the Insulin Growth Factor Receptor Pathway and Other Pathways.
Sparano JA, Gray R, Goldstein LJ, Childs BH, Brassard D, Bugarini R, Rowley S, Baker J, Shak S, Badve S, Baehner FL, Kenny P, Perez EA, Shulman LN, Martino S, Sledge GW, Davidson NE Eastern Cooperative Oncology Group, Brookline, MA; Sanofi-Aventis, Inc., Bridgewater, NJ; Genomic Health, Inc., Redwood City, CA; North Central Cancer Treatment Group, Rochester, MN; Cancer and Leukemia Group B, Chicago, IL; Southwest Oncology Group, Ann Arbor, MI
2009;

Abstract #6004
HER2 Amplification, Polysomy Status and Breast Cancer Survival in a Large Kaiser Permanente Case-Control Study: Assessment of HER2 by Quantitative Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and Fluorescence In
Baehner FL, Achacoso N, Maddala T, Alexander C, Shak S, Quesenberry CP, Habel LA University of California, San Francisco, San Francisco, CA; Kaiser Permanente Northern
2009;

Abstract #6021
Molecular Characterization of Breast Cancer Core Biopsy Specimens by Gene Expression Analysis Using Standardized Quantitative RT-PCR.
Anderson JM, Shak S, Millward C, Labusch M, Chen I, Watson D, Baehner FL Genomic Health, Inc., Redwood City, CA

2009 Kyoto Breast Cancer Consensus Conference International Convention―Kyoto, Japan

Abstract
The First Report Of The Association Between The Recurrence Score And The Risk Of Recurrence In A Japanese Population
M. Toi, H. Iwata, N. Masuda, S. Ohno, S. Namakura, Y.Yamanaka, T. Nakayama, M. Kashiwaba, S, Kamigaki, K. Aogi, T. Ueno, K. Kuroi.
2009;

2009 ASCO Breast Meeting - San Francisco, CA

ASCO 2009 Abstract #4000
A quantitative multi-gene RT-PCR assay for prediction of recurrence in stage II colon cancer: Selection of the genes in 4 large studies and results of the independent, prospectively-designed QUASAR validation study
D. Kerr, R. Gray, P. Quirke, D. Watson, G. Yothers, I. C. Lavery, M. Lee, M. J. O'Connell, S. Shak, N. Wolmark and the Genomic Health & QUASAR Colon Teams; University of Oxford, Oxford, UK; Birmingham Clinical Trials Unit, Birmingham, UK; Leeds Institute of Molecular Medicine, Leeds, UK; Genomic Health, Inc., Redwood City, CA; NSABP, Pittsburgh, PA; Cleveland Clinic Foundation (CCF), Cleveland, OH; Genomic Health, Inc., Redwood City, CA; NSABP, Pittsburgh, PA; Genomic Health, Inc., Redwood City, CA; NSABP, Pittsburgh, PA
2009;

Abstract # 64
Biopsy Cavities in Breast Cancer Specimens: Their Impact on Quantitative RT-PCR Gene Expression Profiles and Recurrence Risk Assessment
FL Baehner, C. Quale, D. Cherbavaz, C. Sangli, C. Pomeroy, A. Chen, F. Lane, L. Intagliatta, A. Goddard, S. Shak; University of California, San Francisco, Redwood City, CA; Genomic Health, Redwood City, CA
2009;

2009 ASCO Annual Meeting― Orlando, FL

Abstract # 500
Genotypic characterization of phenotypically defined triple-negative breast cancer

2009;

Abstract # 549
Molecular characterization of male breast cancer by standardized quantitative RTPCR analysis: First large genomic study of 347 male breast cancers compared to 82,434 female breast cancers.
S. Shak, G. Palmer, F. L. Baehner, C. Millward, D. Watson, G. W. Sledge
2009;

2008 San Antonio Breast Cancer Symposium (SABCS)-San Antonio, TX

Abstract # 2066
Quantitative gene expression analysis using Oncotype DX in ductal carcinoma in
Baehner FL, Sangli C, Millward C, Cherbavaz D, Goddard A, Shak S Genomic Health,Inc, Redwood City, CA
2008;

Abstract # 25
GRB7-dependent pathways are potential therapeutic targets in triple-negative
Sparano JA, Gray R, Goldstein LJ, Childs BH, Bugarini R, Rowley S, Baker J, Shak S,
2008;

Abstract # 3049
Associations between estrogen receptor (ER) Alpha expression levels and ER genotypes
Henry NL, Shak S, Banerjee M, Skaar T, Palmer G, Braman M, Stearns V,Flockhart DA, Kleer C, Hayes DF, Rae J University of Michigan, Ann Arbor, MI; Genomic Health,Inc., Redwood City, CA; Indiana University, Indianapolis, IN; Johns Hopkins University,Baltimore, MD
2008;

Abstract # 53
Risk of distant recurrence using Oncotype DX in postmenopausal primary breast
Dowsett M, Cuzick J, Wales C, Forbes J, Mallon L, Salter J, Quinn E, Bugarini R,
2008;

2008 ASCO Annual Meeting―Chicago, IL

Predictive Utility of Progesterone Receptor (PR) and Multigene Expression in Identifying Benefit From Adjuvant Doxorubicin Plus Cyclophosphamide (AC) or Docetaxel (AT) in Intergroup Trial E2197
LJ Goldstein, RJ Gray, R Bugarini, S Shak, SS Badve, FL Baehner, NE Davidson, GW Sledge, JA Sparano, The North American Breast Cancer Intergroup
2008;

2008 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium—Washington DC

Abstract #13
HER2 Concordance Between Central Laboratory Immunohistochemistry & Quantitative Reverse Transcription Polymerase Chain Reaction in Intergroup Trial E2197
FL Baehner, R Gray, B Childs, T Maddala, S Rowley, S Shak, NE Davidson, GW Sledge, LJ Goldstein, JA Sparano, S Badve
2008;

Abstract #41
HER2 Assessment in a Large Kaiser Permanente Case-Control Study: Comparison of Fluorescence In Situ Hybridization (FISH) and Quantitative Reverse Transcription Polymerase Chain Reaction (RTPCR) Performed by Central Laboratories
FL Baehner, Achacoso, T Maddala, C Alexander, S Shak, CP Quesenberry, LC Goldstein, AM Gown, LA Habel
2008;

Abstract #44 : Poster Session
Comparison of ER and PR Assessment by Local IHC, Central IHC, and Central Quantitative RT-PCR in ECOG Breast Cancer Study 2197
S Badve, FL Baehner, R Gray, B Childs, T Maddala, M Liu, S Rowley, N Davidson, LJ Goldstein, GW Sledge, JA Sparano
2008;

Abstract #47 : Poster Session
A Kaiser-Permanente Population-Based Study of Breast Cancer ER and PR Expression by the Standard Method, Immunohistochemistry, Compared to a New Method, Quantitative Reverse Transcription Polymerase Chain Reaction
FL Baehner, T Maddala, C Alexander, A Gown, LC Goldstein, y, S Shak, CP Quesenberry, L Habel
2008;

Abstract #50 : Poster Session
Heterogeneity of Quantitative RT-PCR Measurement of Estrogen and Progesterone Receptor Expression: Comparison of Tissue Microarray Cores to Whole Sections of Paraffin Embedded Breast Cancer Tissue
FL Baehner, J Baker, J Salter, ML Liu, C Yoshizawa, T Maddala, M Dowsett, M Cronin, S Shak
2008;

Abstract #82 : Oral Presentation
Analysis of Revised Nottingham Tumor Grade Constitutive Components and Recurrence Free Interval in ECOG Breast Cancer Study E2197
FL Baehner, LJ Goldstein, R Gray, T Maddala, S Shak, GW Sledge, JA Sparano, S Badve
2008;

2007 San Antonio Breast Cancer Symposium (SABCS)―San Antonio, TX

Abstract #1043 : Poster Session
Recurrence Score by Oncotype DX Evaluated on the Primary Breast Predicts the 2-Year Survival after First Relapse
G Bianchini, M Zambetti, P Mariani, A Moliterni, G Bianchi, G Mariani, A Fasolo, ML Carcangiu, P Valagussa, L Gianni
2007;

Abstract #10 : Oral Presentation
Prognostic and Predictive Value of the 21-Gene Recurrence Score Assay in Postmenopausal, Node-Positive, ER-Positive Breast Cancer
K Albain, W Barlow, S Shak, G Hortobagyi, R Livingston, I Yeh, P Ravdin, C Yoshizawa, FL Baehner, N Davidson, G Sledge, E Winer, C Hudis, J Ingle, E Perez, K Pritchard, L Shepherd, C Allred, K Osborne, D Hayes
2007;

Abstract #1092 : 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 #2061 : Poster Session
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
2007;

Abstract #3028 : Poster Session
Gene Expression by Standardized Quantitative RT-PCR in the Special Histologic Subtypes of Estrogen Receptor-Positive Invasive Breast Cancer
FL Baehner, D Watson, JT Ballard, G Palmer, S Shak
2007;

Abstract #3082 : 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
2007;

Abstract #5029 : Poster Session
Estrogen Receptor and Breast Cancer Survival in a Kaiser Permanente Population-Based Study: Comparison of Quantitative Reverse Transcriptase Polymerase Chain Reaction and Immunohistochemistry
LA Habel, N Achacoso, T Maddala, C Alexander, FL Baehner, S Shak, C Quesenberry, AM Gown, LC Goldstein
2007;

Abstract #63 : Oral Presentation
Prognostic Utility of the 21-Gene Assay Compared with Adjuvant! in Hormone Receptor (HR) Positive Operable Breast Cancer with 0-3 Positive Axillary Nodes Treated with Adjuvant Chemohormonal Therapy (CHT): An Analysis of Intergroup Trial E2197
L Goldstein, P Ravdin, R Gray, C Yoshizawa, B Childs, S Rowley, S Shak, S Badve, FL Baehner, N Davidson, GW Sledge, JA Sparano

2007 ASCO Breast Cancer Symposium―San Francisco, CA

Abstract #106
Use of Estrogen Receptor (ER) Expression by Quantitative RT-PCR to Identify an ER-Negative Subgroup by IHC Who Might Benefit from Hormonal Therapy
G Bianchini, M Zambetti, L Pusztai, M Carcangiu, P Valagussa, L Gianni
2007;

Abstract #27
Association of Individual Genes with Risk of Relapse in Operable Breast Cancer: Analysis of E2197
JA Sparano, L Goldstein, B Childs, C Yoshizawa, S Shak, J Baker, S Rowley, N Davidson, S Badve, GW Sledge Jr., R Gray
2007;

Abstract #87
ER and PR Assessment in ECOG 2197: Comparison of Locally Determined IHC with Centrally Determined IHC and Quantitative RT-PCR
SS Badve, FL Baehner, R Gray, B Childs, T Maddala, M Liu, S Rowley, N Davidson, S Shak, GW Sledge Jr., JA Sparano
2007;

Abstract #88
A Kaiser-Permanente Population-Based Study of ER and PR Expression by the Standard Method, Immunohistochemistry (IHC), Compared to a New Method, Quantitative Reverse Transcription Polymerase Chain Reaction (RT-PCR)
FL Baehner, T Maddala, C Alexander, A Gown, LC Goldstein, NS Achacoso, S Shak, CP Quesenberry, LA Habel
2007;

2007 ASCO Annual Meeting―Chicago, IL

Poster Discussion
Prognostic Utility of the 21-Gene Assay in Hormone Receptor (HR)-Positive Operable Breast Cancer and 0-3 Positive Axillary Nodes Treated with Adjuvant Chemohormonal Therapy (CHT): An Analysis of Intergroup Trial E2197
LJ Goldstein, R Gray, B Childs, D Watson, S Rowley, S Shak, S Badve, NE Davidson, GW Sledge, JA Sparano
2007;

Abstract #577 : 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
2007;

2007 American Association for Cancer Research (AACR) Annual Meeting―Los Angeles, CA

Abstract #4423 : Poster Session
Optimized RNA Extraction and RT-PCR Provide Successful Molecular Analysis on a Variety of Archival Fixed Tissues
M Zhou, M Bronner, C Magi-Galluzzi, R Tuthill, FL Baehner, ML Liu, D Dutta, J Jeong, YT Chen, JR Hackett, M Cronin
2007;

2006 SABCS―San Antonio, TX

Abstract #3116 : Poster Presentation
A Comparison of Estrogen Receptor (ER) Measurement by Three Methods in Node-Negative, Estrogen Receptor (ER)-Positive Breast Cancer: Ligand Binding (LB), Immunohistochemistry (IHC), and Quantitative RT-PCR
C Kim, G Tang, FL Baehner, D Watson, JP Costantino, S Paik, S Shak, N Wolmark
2006;

Abstract #45 : Oral Presentation
Quantitative RT-PCR Analysis of ER and PR by Oncotype DX Indicates Distinct and Different Associations with Prognosis and Prediction of Tamoxifen Benefit
FL Baehner, LA Habel, CP Quesenberry, A Capra, G Tang, S Paik, N Wolmark, D Watson, S Shak
2006;

Abstract #6039 : Poster Presentation
The Impact on the Recurrence Score Due to Patient Variation in the Quantitative Expression of Individual Genes or Gene Groups
D Watson, G Palmer, J Baker, S Shak
2006;

Abstract #6111 : Poster Presentation
Relationship Between Proliferation Genes and Expression of Hormone and Growth Factor Receptors: Quantitative RT-PCR in 10,618 Breast Cancers
S Shak, FL Baehner, G Palmer, JT Ballard, J Baker, D Watson
2006;

Abstract #6118 : Poster Presentation
Subtypes of Breast Cancer Defined by Standardized Quantitative RT-PCR Analysis of 10,618 Tumors
S Shak, FL Baehner, G Palmer, JT Ballard, J Baker, D Watson
2006;

2006 Association for Molecular Pathology (AMP) Annual Meeting―Orlando, FL

Poster ST23 : Poster ST23
Analytical Validation for the Oncotype DX Breast Cancer Assay, High Complexity, Multi-Analyte Molecular Diagnostic Test Service
M Cronin, C Sangli, ML Liu, M Pho, D Dutta, A Nguyen, J Jeong, J Wu, K Clark, D Watson
2006;

2006 ASCO Annual Meeting―Atlanta, GA

Abstract #538 : Poster Discussion
Gene Expression Profiles in Formalin-Fixed, Paraffin-Embedded (FFPE) Core Biopsies Predict Docetaxel Chemosensitivity
JC Chang, A Makris, SG Hilsenbeck, JR Hackett, J Jeong, ML Liu, J Baker, K Sexton, CK Osborne, S Shak
2006;

Abstract #6024 : Poster Discussion
21-Gene RT-PCR Assay in Lymph Node-Negative (LN-), Estrogen Receptor-Positive (ER+) Breast Cancer: An Economic Analysis Including Prognostic and Predictive Information
LE Cosler, NM Kuderer, J Hornberger, GH Lyman
2006;

2006 AACR Annual Meeting―Washington, DC

Abstract #3604 : Poster Discussion
Multiple GSTM Gene Family Members Are Recurrence Risk Markers in Breast Cancer
M Kiefer, K Hoyt, J Hackett, MG Walker, J Baker
2006;

2005 SABCS―San Antonio, TX

Abstract #2049 : Poster Session
Impact of Oncotype DX™ on Decision Making in Breast Cancer Clinical Practice
R Oratz, D Paul, A Cohn, S Sedlacek
2005;

Abstract #29 : Oral Presentation
Association Between the 21-Gene Recurrence Score Assay (RS) and Risk of Loco-Regional Failure in Node-Negative, ER-Positive Breast Cancer: Results from NSABP B-14 and NSABP B-20
E Mamounas, G Tang, J Bryant, S Paik, S Shak, JP Costantino, D Watson, DL Wickerham, N Wolmark
2005;

Abstract #310 : Poster Discussion
Measurement of Gene Expression Using Tissue Microarray Cores of Paraffin-Embedded Breast Cancer Tissue
J Baker, J Salter, ML Liu, JR Hackett, M Cronin, S Shak, M Dowsett
2005;

2005 ASCO Annual Meeting―Orlando, FL

Abstract #510 : Oral Presentation
Expression of the 21 Genes in the Recurrence Score Assay and Tamoxifen Clinical Benefit in the NSABP Study B-14 of Node-Negative, Estrogen Receptor-Positive Breast Cancer
S Paik, S Shak, G Tang, C Kim, J Baker, M Cronin, D Watson, J Bryant, JP Costantino, N Wolmark
2005;

Abstract #603 : Poster Session
Gene Expression and Breast Cancer Mortality in Northern California Kaiser Permanente Patients: A Large Population-Based Case Control Study
LA Habel, CP Quesenberry, M Jacobs, D Greenberg, L Fehrenbacher, C Alexander, J Baker, D Watson, J Hackett, S Shak
2005;

2004 USCAP Annual Meeting―Vancouver, British Columbia

Abstract #1491
Reproducibility of Quantitative Gene Expression Analysis by a New RT-PCR Assay Using Fixed Paraffin-Embedded Tissues: A Molecular Tomographic Scanning Study
M Cronin, D Watson, D Dutta, ML Liu, M Pho, R Baehner, J Esteban, J Baker, S Shak
2004;

Abstract #80
Use of Macrodissection in Multi-Gene RNA Analysis of Fixed Paraffin- Embedded Tumor Tissue
R Baehner, B Hiller, CY Kim, C Alexander, ML Liu, M Pho, D Dutta, J Jeong, A Nguyen, M Walker, M Cronin, J Baker, S Paik
2004;

Abstract #83 : Oral Presentation
Comparison of ER, PR, HER2, and Ki-67 Quantitative Expression in Formalin-Fixed, Paraffin-Embedded Breast Carcinomas by RT-PCR with Protein Expression by Immunohistochemistry
P Bitterman, D Watson, M Cronin, JM Mosquera, M Cobleigh, R Baehner, S Shak, J Baker
2004;

2004 SABCS―San Antonio, TX

Abstract #104 : Poster Discussion
Risk Classification of Breast Cancer Patients by the Recurrence Score Assay: Comparison to Guidelines Based on Patient Age, Tumor Size, and Tumor Grade
S Paik, S Shak, G Tang, C Kim, J Baker, M Cronin, FL Baehner, MG Walker, D Watson, J Bryant, N Wolmark
2004;

Abstract #2081 : Poster Discussion
A 21-Gene RT-PCR Assay in Lymph Node-Negative (LN-), Estrogen Receptor-Positive (ER+) Early-Stage Breast Cancer (ESBC): An Age-Specific Economic Analysis
GH Lyman, L Cosler, J Hornberger
2004;

Abstract #24 : Oral Presentation
Expression of the 21 Genes in the Recurrence Score Assay and Prediction of Clinical Benefit from Tamoxifen in NSABP Study B-14 and Chemotherapy in NSABP Study B-20
S Paik, S Shak, G Tang, C Kim, H Joo, J Baker, M Cronin, D Watson, J Bryant, JP Costantino, N Wolmark
2004;

2004 ASCO Annual Meeting―New Orleans, LA

Abstract #501 : Oral Presentation
Gene Expression Profiles of Paraffin-Embedded Core Biopsy Tissue Predict Response to Chemotherapy in Patients with Locally Advanced Breast Cancer
L Gianni, M Zambetti, K Clark, J Baker, M Cronin, G Mariani, J Rodriguez, M Carcangiu, D Watson, P Valagussa, S Shak
2004;

Abstract #6036 : Poster Session
Economic Analysis of Targeting Chemotherapy (CT) Using a 21-Gene RT-PCR Assay in Lymph Node-Negative (LN-), Estrogen Receptor-Positive (ER+) Early-Stage Breast Cancer (ESBC)
LE Cosler, J Hornberger, GH Lyman
2004;

2003 SABCS―San Antonio, TX

Abstract #16 : Oral Presentation
Multi-Gene RT-PCR Assay for Predicting Recurrence in Node-Negative Breast Cancer Patients - NSABP Studies B-20 and B-14
S Paik, S Shak, G Tang, C Kim, J Baker, M Cronin, FL Baehner, MG Walker, DWatson, T Park, W Hiller, ER Fisher, DL Wickerham, J Bryant, N Wolmark
2003;

Abstract #17 : Oral Presentation
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
2003;

2003 ASCO Annual Meeting―Chicago, IL

Abstract #3415 : Poster Session
Tumor Gene Expression Predicts Distant Disease-Free Survival (DDFS) in Breast Cancer Patients with 10 or More Positive Nodes: High Throughput RT-PCR Assay of Paraffin-Embedded Tumor Tissues
MA Cobleigh, P Bitterman, J Baker, M Cronin, ML Liu, R Borchik, B Tabesh, J Mosquera, MG Walker, S Shak
2003;

Abstract #3416 : Poster Discussion
Tumor Gene Expression and Prognosis in Breast Cancer: Multi-Gene RT-PCR Assay of Paraffin-Embedded Tissue
JM Esteban, J Baker, M Cronin, ML Liu, MG Llamas, MG Walker, R Mena, S Shak
2003;

Abstract #3466 : Poster Session
Predicting Response to Neoadjuvant Chemotherapy in Invasive Breast Cancer: Gene Expression Profiling of Paraffin-Embedded Core Biopsy Tissue
SE Soule, S Shak, J Baker, M Cronin, ML Liu, S Badve, KD Miller, GW Sledge
2003;

2003 AACR Oncogenomics Meeting―Phoenix, AZ

Poster Session : Poster Session
Gene Expression Profiling of Fixed, Paraffin-Embedded Tumor Specimens, Using a 192 Gene Panel RT-PCR Assay
M Kiefer, J Stephans, ML Liu, D Dutta, M Pho, A Nguyen, J Jeong, M Cronin, JM Esteban
2003;

2002 ASCO Annual Meeting―Orlando, FL

Abstract #3017
Gene Expression Profiling of Fixed Paraffin-Embedded Breast Cancer Tissues
M Kiefer, J Stephans, S Abulaban, S Shodhan, MC Alexander, JM Esteban
2002;

Abstract#2601: Poster Session
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
2008;

Oncotype DX tools (RSPC)

Peer-reviewed Publication(s)

Risk of Recurrence and Chemotherapy Benefit for Patients With Node-Negative, Estrogen Receptor–Positive Breast Cancer: Recurrence Score Alone and Integrated With Pathologic and Clinical Factors
Tang G., Cuzick J., Costantino JP., Dowsett M., Forbes JF., Crager M., Mamounas EP., Shak S., and Wolmark N.
J Clin Oncol. 2011; 4365-4372.

2011 ASCO - Chicago, IL.

Abstract #592
Using the 21-gene Recurrence Score and the recently developed Recurrence Score-Clinical-Pathologic to assess recurrence risk in patients with node-negative, ER-positive early-stage breast cancer receiving aromatase inhibitor treatment alone.
M. Crager, G. Tang, S. Shak; Genomic Health, Redwood City, CA; NSABBP Biostatistical Center and University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA
2011;

2010 SABCS---San Antonio, TX

Abstract #S4-9
Comparing the prediction of chemotherapy benefit in patients with node-negative, ER-positive breast cancer using the recurrence score and a new measure that integrates clinical and pathologic factors with the recurrence score
Tang G, Costantino JP, Crager M, Shak S, Wolmark N. NSABP, Pittsburgh, PA, Genomic Health Inc., Redwood City, CA.
2010;

2010 ASCO - Chicago, IL.

Abstract #509
Recurrence risk of node-negative and ER-positive early-stage breast cancer patients by combining recurrence score, pathologic, and clinical information: A meta-analysis approach.
G. Tang, J. Cuzick, C. Wale, J. P. Costantino, M. Crager, S. Shak, N. Wolmark, M. Dowsett, J. F. Forbes; National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA; Queen Mary, University of London, London, United Kingdom; Genomic Health, Redwood City, CA; National Surgical Adjuvant Breast and Bowel Project and Allegheny General Hospital, Pittsburgh, PA; The Royal Marsden Hospital, London, United Kingdom; University of Newcastle, Newcastle-upon-Tyne, United Kingdom
2010;