Clinical evidence for the Oncotype DX® test in node-negative patients

The clinical validity and utility of the Oncotype DX Breast Recurrence Score® test in patients with HR+, HER2-, node-negative, early-stage, invasive breast cancer have been established through extensive clinical research in over 85,000 patients.1-3,5,7

Only the Oncotype DX Breast Recurrence Score test is clinically validated for prediction of chemotherapy benefit2,5

  • The Oncotype DX Breast Recurrence Score test is clinically validated as prognostic of distant recurrence for node-negative, HR+ early-stage breast cancer patients1
  • The Oncotype DX test is clinically validated to predict chemotherapy benefit in the 2-arm randomised clinical trial NSABP B-202,5,7 (interaction between Recurrence Score result and benefit from chemotherapy p=0.0145).
  • The practice-changing TAILORx study, a prospective randomised clinical trial, was confirmatory of former findings, enabling a more precise threshold for CT benefit.3,7,8

Establishing prediction of chemotherapy benefit with precision

Clinical evidence from the TAILORx and NSABP B-20 studies established that the Oncotype DX® test can identify two groups of patients: those who can be spared chemotherapy and those who will significantly benefit from it.3,5

Patients with Recurrence Score results 0–25 do not benefit from the addition of chemotherapy to endocrine therapy2,3,5


~ 80% of the patients overall

3,6,9

Patients with Recurrence Score results 26–100 significantly benefit from the addition of chemotherapy to endocrine therapy2,5

~ 20% of the patients overall

3,6,9

The landmark practice-changing TAILORx study

The NSABP B-20 trial established that patients with Recurrence Score results 0-10 do not benefit from the addition of CT to ET and that patients with a Recurrence Score result 26-100 do benefit from the addition of CT5. TAILORx was designed to determine whether endocrine therapy is non-inferior to chemotherapy plus endocrine therapy in patients with Recurrence Score results 11-25.3,5,8

TAILORx confirmed that patients with Recurrence Score results 11-25 do not benefit from the addition of chemotherapy to endocrine therapy3

TAILORx met its primary and secondary endpoints: patients with Recurrence Score results 11-25 treated with chemoendocrine therapy had similar rates of clinical events to patients receiving endocrine therapy alone.3

Prospectively planned analysis in TAILORx established that clinical pathological features and clinical risk, as assessed by tumour size and grade according to modified Adjuvant!Online, add prognostic value to estimate the clinical outcome of patients receiving endocrine therapy alone; however, clinical risk was not associated with response to chemotherapy.3,19

There were further new exploratory analyses aimed at identifying any subgroups of patients who may benefit from chemotherapy. The Recurrence Score result and patient age, in combination, may modify treatment response: patients ≤50 years and with Recurrence Score results 16-25 may benefit from chemotherapy, as detailed in the table below.3,19

Are patients enrolled in TAILORx representative of clinical practice?

Patients from TAILORx are comparable to those treated in clinical practice during the same period reported in the SEER registry.3,6,8,11

Real-World Evidence

Real-world evidence is consistent with clinical studies. It confirms that the Oncotype DX® test consistently identifies a minority of patients (~ 20% overall) with Recurrence Score results 26-100 who derive increasing benefit from chemotherapy.2,5,7

More on Surveillance Epidemiology and End Results (SEER) registry

Analysis of the real-world SEER study cohort (including >70,000 patients) further supported the evidence that the Oncotype DX Breast Recurrence Score result predicts CT benefit.6

9-year Breast Cancer Specific Survival (BCSS) was >97% without chemotherapy*, regardless of nodal status6

*CT use reported as “no/unknown”


KEY STUDY DETAILS

  • NSABP B-14 Study:1 The first clinical validation of the Oncotype DX Breast Recurrence Score® test, the NSABP B-14 study, demonstrated that the Recurrence Score result quantifies the risk of distant recurrence in node-negative patients. It showed that the 10-year rate of distant recurrence is significantly lower for patients with low Recurrence Score results compared to patients with higher Recurrence Score results.
  • NSABP B-20 Study:2,5,7 This study determined that the Oncotype DX Breast Recurrence Score® test predicts the likelihood of chemotherapy benefit for node-negative patients: a low Recurrence Score result predicted little to no benefit from the addition of chemotherapy to endocrine therapy, while a high Recurrence Score result predicted a larger benefit from chemotherapy.
  • TAILORx:3 The first prospective outcomes study providing Level 1A evidence for a multigene assay, TAILORx established that, overall, patients with Recurrence Score results 11-25 do not benefit from the addition of chemotherapy to endocrine therapy and may be effectively treated with hormonal therapy alone.
ABBREVIATIONS

BCSS = breast cancer specific survival
CI=confidence interval
CT=chemotherapy
ET=endocrine therapy
HER2–=human epidermal growth factor receptor 2 negative
HR+=hormone receptor positive
HR=hazard ratio
N0=node-negative
NSABP = National Surgical Adjuvant Breast and Bowel Project
RS=Recurrence Score result
SEER=Surveillance, Epidemiology and End Results program
TAILORx=Trial Assigning IndividuaLized Options for Treatment (Rx)

REFERENCES
  1. Paik et al. N Engl J Med. 2004.
  2. Paik et al. J Clin Oncol. 2006.
  3. Sparano et al. N Engl J Med. 2018.
  4. Ballman et al. J Clin Oncol. 2015.
  5. Geyer et al. NPJ Breast Cancer. 2018
  6. Hortobagyi et al. SABCS. 2018.
  7. Sparano and Paik. J Clin Oncol. 2008.
  8. Sparano et al. N Engl J Med. 2015.
  9. Stemmer et al. NPJ Breast Cancer. 2017.
  10. Blohmer et al. ESMO. 2017.
  11. Petkov et al. NPJ Breast Cancer. 2016.
  12. Genomic Health. Data on File. 2019.
  13. IQWiG. Press release. 2018.
  14. Andre et al. J Clin Oncol. 2019.
  15. NCCN Guidelines. 2018. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V3.2021. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 15, 2021. 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.
  16. NICE. 2018. © NICE 2018 Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. Available from www.nice.org.uk/guidance/dg34. All rights reserved. Subject to Notice of rights NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
  17. Cardoso et al. Ann Oncol. 2019.
  18. Burnstein et al. Ann Oncol. 2019.
  19. Sparano et al. N Engl J Med. 2019.
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