1. Data on file at Genomic Health, Inc.
2. Markopoulos C, Hyams DM, Gomez HL, et al. Multigene assays in early breast cancer: Insights from recent phase 3 studies. Eur J Surg Oncol. 2020;46(4 Pt A):656-666.
3. Hyams DM, Schuur E, Angel Aristizabal J, et al. Selecting postoperative adjuvant systemic therapy for early stage breast cancer: A critical assessment of commercially available gene expression assays. J Surg Oncol. 2017;115(6):647-662.
4. Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24(23):3726-3734.
5. Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med. 2004;351(27):2817-2826.
6. Dowsett M, Cuzick J, Wale C, et al. 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. J Clin Oncol. 2010;28(11):1829-1834.
7. Albain KS, Barlow WE, Shak S, et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. The Lancet Oncology. 2010;11(1):55-65.
8. Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379(2):111-121.
9. Kalinsky K, Barlow WE, Gralow JR, et al. 21-Gene Assay to Inform Chemotherapy Benefit in Node-Positive Breast Cancer. N Engl J Med. 2021;385(25):2336-2347.
10. Kalinsky K, et al. Distant-disease free interval in participants with 1-3 positive lymph nodes, hormone receptor-positive and HER2-negative breast cancer with recurrence score ≤ 25 randomized to endocrine therapy +/- chemotherapy: SWOG S1007 (RxPONDER). Oral Presentation at: San Antonio Breast Cancer Symposium; December 2021.
11. Cardoso F, van't Veer LJ, Bogaerts J, et al. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med. 2016;375(8):717-729.
12. Hyams DM, Schuur E, Angel Aristizabal J, et al. Selecting postoperative adjuvant systemic therapy for early stage breast cancer: A critical assessment of commercially available gene expression assays. J Surg Oncol. 2017;115(6):647-662.
13. Referenced with permission from the NCCN Guidelines® for Breast Cancer V.2.2022. ©National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed March 8, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org.
14. Andre F, Ismaila N, Allison KH, et al. Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer: ASCO Guideline Update [Published online ahead of print Apr 19 2022]. J Clin Oncol. DOI:10.1200/JCO.22.00069.
15. Cardoso F, Kyriakydes, Ohno S, et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30(8):1194-1220.
16. Burstein HJ, Curigliano G, Loibl S, et al. Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol. 2019;30(10):1541-1557.
17. AGO Breast Committee. Diagnostic and Treatment of Patients with Early and Advanced Breast Cancer. Version 2020.1. https://www.ago-online.de/en/. Accessed May 20, 2022.
18. Amin MB, Greene FL, Edge SB, et al. The Eight Edition AJCC Cancer Staging Manual: Continuing to Build a Bridge from a Population-Based to a More “Personalized” Approach to Cancer Staging. CA Cancer J Clin. 2017; 67(2):93-99.
19. Stemmer SM, Steiner M, Rizel S, et al. Clinical outcomes in ER+ HER2 -node-positive breast cancer patients who were treated according to the Recurrence Score results: evidence from a large prospectively designed registry. NPJ Breast Cancer. 2017;3:32.
20. Stemmer SM, Steiner M, Rizel S, et al. Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry. Npj Breast Cancer. 2017;3:33.
21. Hortobagyi GN, Shak S, Sledge GW. Breast cancer-specific mortality in patients with node-negative and node-positive breast cancer guided by the 21-gene assay: A SEER-genomic population-based study. In San Antonio Breast Cancer Symposium (SABCS). 2018:4-8.
22. Nitz U, Gluz O, Christgen M, et al. Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial. Breast Cancer Res Treat. 2017;165(3):573-583.
23. Drukker CA, Bueno-de-Mesquita JM, Retèl VP, et al. A prospective evaluation of a breast cancer prognosis signature in the observational RASTER study. Int J Cancer. 2013;133(4):929-936.
24. van de Vijver MJ, He YD, van’t Veer, LJ, et al. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002;347(25):1999-2009.
25. Buyse M, Loi S, van’t Veer L, et al. Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. J Natl Cancer Inst. 2006;98(17):1183-1192.
26. Esserman LJ, Yau C, Thompson CK, et al. JAMA Oncol. Use of Molecular Tools to Identify Patients With Indolent Breast Cancers With Ultralow Risk Over 2 Decades. JAMA Oncol. 2017;3(11):1503-1510.
27. Habel LA, Shak S, Jacobs MK, et al. A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. Breast Cancer Res. 2006;8(3):R25.
28. Toi M, Iwata H, Yamanaka T, et al. Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population. Cancer. 2010;116(13):3112-3118.