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 700,000 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

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 likelihood 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 testss 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 2015 19
  • 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 patients4-18,20-33

Genomic Health
ONCOTYPE DX
NanoString
PROSIGNA®
Agendia®
MAMMAPRINT®
bioTheranostics
BREAST CANCER INDEX™
Myriad
ENDOPREDICT®
Validated for
Prognosis
Node Negative and Node Positive ✔︎ ✔︎ ✔︎ ✔︎ ✔︎
Pre-Menopausal ✔︎ ✔︎ ✔︎ ✔︎
Post-Menopausal ✔︎ ✔︎ ✔︎ ✔︎ ✔︎
Homogenous Populations ✔︎ ✔︎ ✔︎ ✔︎
Validated for prediction of Chemotherapy Benefit ✔︎
Inclusion in Major International Guidelines*
NCCN® Algorithm and NICE (UK) ✔︎
NCCN Discussion Section ✔︎ ✔︎ ✔︎
ASCO® ✔︎ ✔︎ ✔︎
ESMO, St. Gallen and AGO ✔︎ ✔︎ ✔︎ ✔︎
Prospective Outcomes Evidence >63,000 patients >7,000 patients
Inclusion in AJCC 8th Ed. Cancer Staging Manual for assignment of Prognostic Stage Group 1A ✔︎
Additional Clinical Evidence DCIS, Neoadjuvant, Late Recurrence, Adjuvant Hormonal Therapy Benefit Neoadjuvant, Late Recurrence Neoadjuvant Late Recurrence, Adjuvant Hormonal Therapy Benefit Late Recurrence

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 8th edition.2017.
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.1.2017.
21. NICE Diagnostics Guidance 10. 2013.
22. Harris et al. J Clin Oncol. 2016.
23. Senkus et al. Ann Oncol. 2015.
24. Coates et al. Ann Oncol. 2015.
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.

A. N Engl J Med 2015;373:2005-14. DOI: 10.1056/NEJMoa1510764.

*American Society of Clinical Oncology (ASCO) and ASCO are registered trademarks of ASCO; National Comprehensive Cancer Network (NCCN) and NCCN are registered trademarks of NCCN; AJCC is a registered trademark of the American College of Surgeons. ASCO, NCCN, 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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