Oncotype DX Breast Recurrence Score

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.

Prediction of chemotherapy benefit with precision makes the Oncotype DX Breast Recurrence Score assay unique

  • The Oncotype DX Breast Recurrence Score® test was validated as prognostic of distant recurrence for node-negative, HR+ early stage breast cancer patients1
  • The Oncotype DX test was uniquely validated to predict chemotherapy benefit in the 2-arm randomized clinical trial NSABP B-202,5,7 (interaction between Recurrence Score result and benefit from chemotherapy p=0.0145).
  • The practice-changing TAILORx prospective randomized clinical trial refined 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 precisely identify two groups of patients: those who can be spared chemotherapy and those who will substantially 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 patients3,6,9

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

~ 20% of the patients3,6,9

TAILORx landmark practice-changing trial

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. The TAILORx trial was designed to determine whether ET was non-inferior to CT+ET in patients with Recurrence Score results 11-25.3,8

TAILORx proved that patients with Recurrence Score results 11-25 do not benefit from chemotherapy

The TAILORx study met its primary and secondary endoints: patients with Recurrence Score results 11-25 treated with chemoendocrine therapy had similar rates of clinical events to patients receiving endocrine therapy alone in non-inferiority design invasive disease-free survival (primary endpoint), distant recurrence-free interval and overall survival.3,8

TAILORx's pre-planned analysis established that clinical risk, as assessed by tumor size and grade according to modified Adjuvant!Online, added prognostic value to estimate the clinical outcome of patients receiving endocrine therapy alone; however, it was not associated with response to chemotherapy.3,19

Further exploratory analyses aimed at identifying factors predicting response to chemotherapy. In addition to the Recurrence Score result, age is the only factor that was found to have a correlation with treatment response: patients ≤50 years and with Recurrence Score results 16-25 may benefit from chemotherapy, as detailed in the table below.3,19

Real World Evidence

Real-world evidence is consistent with clinical studies. It confirms that the Oncotype DX test consistently identifies a minority of patients (15-20%) with Recurrence Score results 26-100 who derive substantial benefit from chemotherapy.

Are patients enrolled in the TAILORx study representative of clinical practice?

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

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 scores.
  • 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 score predicted a larger benefit from chemotherapy.
  • TAILORx Study:3,8,19 The first prospective outcomes study providing Level 1A evidence for a multigene assay, the TAILORx Trial confirmed that, overall, patients with Recurrence Score results 11-25 do not benefit from the addition of chemotherapy to endocrine therapy and may be effectively and safely treated with hormonal therapy alone.
ABBREVIATIONS

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
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.
  16. NICE. 2018.
  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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