How Does It Compare to Other Genomic Tests?

The Oncotype DX^® portfolio includes tests for breast, colon, and prostate cancer and have helped more than 1 million patients make more informed treatment choices.¹ Oncotype DX Breast Recurrence Score^® test delivers critical genomic information to help guide treatment decisions that no other genomic test or risk assessment method provides.^2,3

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Reason # 1: Why genomic testing? Why not genetic?

Genetic tests help people understand their risk for getting cancer. Genomic tests help guide people who have been diagnosed with cancer choose an appropriate treatment plan.

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Reason #2: Only the Oncotype DX Breast Recurrence Score test has predictive and prognostic results you can count on for your early-stage invasive breast cancer patients^4-7

Comparison of Multi-gene Breast Cancer Tests

*Predicts the benefit of adding chemotherapy to endocrine therapy.
†Node-negative and postmenopausal, HR positive, HER2 negative breast cancer.
‡Early-stage invasive HR positive, HER2 negative breast cancer.

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Reason #3: Breast Recurrence Score test vs traditional assessment methods

The Breast Recurrence Score test provides strong and consistent information beyond traditional clinical and pathologic features in patient subgroups. Traditionally, breast cancer treatment was based only on clinical-pathologic factors, which provide risk estimates for a patient population. The Breast Recurrence Score test is both prognostic and predictive, providing individualized information about the estimated risk of distant recurrence and benefit of adjuvant chemotherapy that goes beyond traditional assessment menthods.^4-7,27,28

Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V 2.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed May 2, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

ASCO and ESMO are trademarks of the American Society of Clinical Oncology. AJCC is a trademark of the American College of Surgeons. NCCN, ASCO, ESMO, St. Gallen, NICE, AGO and AJCC do not endorse any product or therapy.

References

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.

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