Oncotype DX Breast Recurrence Score

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 The flagship product in the portfolio is the Oncotype DX Breast Recurrence Score test for early-stage, ER+, HER2- invasive breast cancer. The test delivers critical genomic information to guide treatment decisions that no other assay or risk assessment method provides.2,3

Individualized assessment of the risk of distant recurrence and benefit of chemotherapy

Breast Recurrence Score vs. traditional assessment methods

The Breast Recurrence Score test provides strong and consistent information beyond traditional clinical and pathologic features in patient subgroups4-9 Traditionally, breast cancer treatment was based only on clinical-pathologic factors. The Breast Recurrence Score test provides an individualized assessment of risk of distant recurrence4,6 and benefit of chemotherapy5,7 —giving physicians important information about their patients’ individual tumor biology instead of grouping them into a binary low or high risk categories.

The Breast Recurrence Score test is both prognostic and predictive providing prognostic information about the estimated risk of distant recurrence and benefit of adjuvant chemotherapy4-7:

  • An individualized assessment of risk of distant recurrence.
  • Prediction of absolute benefit from chemotherapy.4,7
  • Quantitative ER values by RT-PCR clarify the magnitude of hormonal therapy (tamoxifen) benefit.10
  • Quantitative PR and HER2 values by RT-PCR provide additional information.

In addition, the results report provides an easy-to-understand score (a number from 0-100) that gives an assessment of the patient’s risk for recurrence. This score helps make talking to patients about their test results easy and efficient. Learn more about Recurrence Score results.

Breast Recurrence Score vs. other genomic tests

The data is clear: not all genomic tests are the same. The Breast Recurrence Score test is:

  • The only test recognized by AJCC with Level 1 evidence11, with rigorous validation in six studies4-9 and prospective outcomes in more than 63,000 patients.12-18
  • This assay is the most rigorously tested option and provides proof of the principle that we can develop reproducible predictive tests to select patients who should not receive chemotherapy.”

    — C. Hudis, The New England Journal of Medicine, editorial 201519
  • Incorporated in all major breast cancer treatment guidelines for both prognosis and chemotherapy benefit20-25* including the American Society of Clinical Oncology, (ASCO®), the National Comprehensive Cancer Network (NCCN®), the St. Gallen Consensus panel, the National Institute for Health Care Excellence (NICE), the European Society for Medical Oncology (ESMO) and the German Association of Gynecological Oncology (AGO).
  • Validated to predict both risk of distant recurrence4,6 and chemotherapy benefit5,7 in node-negative and node-positive patients
  • Provides individualized risk of distant recurrence4,6
  • Validated in and appropriate for both pre – and post-menopausal patients4-7

Only Oncotype DX Breast Recurrence Score has predictive and prognostic results you can count on for your early-invasive breast cancer patients

Informing Adjuvant Treatment Decisions Genomic Health Oncotype DX Agendia MammaPrint® NanoString Prosigna® bioTheranostics Breast Cancer Index℠ Myriad Endopredict®
Randomized Clinical Trials
Number of Patients Randomized
  • Oncotype DX: TAILORx34 (9-yr results)=6711
  • WSG PlanB35=2449
  • MammaPrint: MINDACT30 (5-yr results)=2187
N=9160 N=2187
Validated for Prediction of Chemotherapy Benefit2,3
Node-Negative and Node-Positive
Validated for Prognosis2-3,26-29
Node-Negative and Node-Positive
Pre-Menopausal
Post-Menopausal
Homogeneous Populations
Inclusion in Major International Guidelines
NCCN Algorithm: Stronly Consider*20
NCCN Category: Preferred20
NICE (UK) Diagnostics Guidance21
ASCO22,24
ESMO23, St. Gallen38 and AGO25
Inclusion in AJCC 8th Edition Cancer Staging Table for assignment of Pathological Prognostic Stage Group 1A11
Supportive & Prospective Outcomes Evidence
Number of Node-Negative and Node-Positive Patients >96,00012,14,16-18,34-36 >7,00030,31-33,37
Additional Clinical Evidence
DCIS, Neoadjuvant, Late Recurrence, Adjuvant Hormonal Therapy Benefit Neoaduvant Neoadjuvant, Late Recurrence Late Recurrence, Extended Hormonal Therapy Benefit Late Recurrence

*Node-negative, Hormone Receptor-Positive, HER2-Negative disease.

Breast Recurrence Score and Breast DCIS Score

The Breast Recurrence Score test is specifically for patients with anatomic11 stage I, II, or IIIa breast cancer. The Oncotype DX Breast DCIS Score test is a genomic test for patients with ductal carcinoma in situ (DCIS) treated by local excision (with or without tamoxifen).

Genomic testing and genetic testing

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. The Breast Recurrence Score test measures the gene expression in 21 related genes (16 cancer-related genes and 5 reference genes) in a patient’s tumor. The expression of these genes influences the behavior of your patient’s tumor, including how likely it is to grow and spread.

REFERENCES
  1. Data on file at Genomic Health, Inc.
  2. Markopoulos et al. Eur J Surg Oncol. 2016.
  3. Hyams et al. J Surg Oncol. 2017.
  4. Paik et al. J Clin Oncol. 2006.
  5. Paik et al. N Engl J Med. 2004.
  6. Dowsett et al. J Clin Oncol. 2010.
  7. Albain et al. Lancet Oncol. 2010.
  8. Habel et al. Breast Cancer Res. 2006.
  9. Toi et al. Cancer. 2010.
  10. Kim et al. J Clin Oncol. 2010.
  11. AJCC Cancer Staging Manual, Eighth Edition updated 9-Nov-17.
  12. Sparano et al. N Engl J Med. 2015.
  13. Stemmer et al. SABCS 2015.
  14. Petkov et al. npg Breast Cancer. 2016.
  15. Gluz et al. J Clin Oncol. 2016.
  16. Shak et al. ASCO QCS 2016.
  17. Stemmer et al. ESMO 2016.
  18. Shak et al. ESMO 2016.
  19. Hudis,C. editorial, N Engl J Med. 2015.
  20. NCCN Clinical Practice Guidelines in Oncology. V.3.2018.
  21. NICE Diagnostics Guidance 10. 2013.
  22. Harris et al. J Clin Oncol. 2016.
  23. Senkus et al. Ann Oncol. 2015.
  24. Krop et al. J Clin Oncol. 2017.
  25. www.ago-online.de Guidelines Breast Cancer.
  26. Filipits et al. Clin Cancer Res. 2011.
  27. Martin et al. Breast Cancer Research. 2014.
  28. Sgroi et al. Lancet Oncol. 2013.
  29. Zhang et al. Clin Cancer Res. 2013.
  30. Cardoso et al. N Engl J Med. 2016.
  31. Drukker et al. Int J Cancer. 2013.
  32. van de Vijver et al. N Engl J Med. 2002.
  33. Buyse et al. J Natl Cancer Inst. 2006.
  34. Sparano et al. N Engl J Med. 2018.
  35. Nitz et al. Breast Cancer Res Treat. 2017.
  36. Roberts et al. Breast Cancer Res Treat. 2017.
  37. Esserman et al. JAMA Oncol. 2017.
  38. Curigliano et al. Ann Oncol. 2017.
  1. DOI: 10.1056/NEJMoa1510764

NCCN and NCCN Guidelines are trademarks of the National Comprehensive Cancer Network. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.3.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed (March 20, 2018). To view the most recent and complete version of the guideline, go online to NCCN.org.

ASCO is a trademark 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.

Prospective Outcomes:
TAILORxa

The Trial Assigning Individualized Options for Treatment included over 10,000 node negative patients.

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Oncotype DX has it. MammaPrint does not.

Only the Oncotype DX Breast Recurrence Score test predicts chemotherapy benefit.

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