How can I access Oncotype DX® test-related scientific studies?
Click on the links below to view scientific publications of interest to you. You can also download our bibliography. Note that the articles made available below are not intended to be a comprehensive listing of all relevant publications in a particular subject area.
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
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.
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.
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
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.