The value of the Oncotype Breast Recurrence Score® test in clinical practice

For node-negative, early breast cancer patients

The Oncotype DX Breast Recurrence Score® test is the only multi gene assay validated to predict chemotherapy benefit for your patients with HR+, HER2-, node-negative, early-stage, invasive breast cancer1-2 and hence to guide treatment decisions.3

TAILORx and NSABP B20 results show that most patients do not benefit from the addition of chemotherapy to endocrine therapy1-3

How does the Oncotype DX® test guide treatment decisions?

Clinical evidence has demonstrated:

  • Patients with Recurrence Score® results 0–25 do not benefit overall from the addition of chemotherapy to endocrine therapy1–3
  • Patients with Recurrence Score® results 26–100 as a group derive a 26% absolute benefit from the addition of chemotherapy to endocrine therapy1,2
  • Exploratory analysis from TAILORx suggests that some patients ≤50 years of age with Recurrence Score® results 16–25 may derive some benefit from chemotherapy3,14

How does the Oncotype DX® test reduce the risk of over- and undertreatment?

  • In multiple decision impact studies worldwide, the Oncotype DX Breast Recurrence Score® test significantly affected treatment decisions4-12
  • Clinical pathologic risk features alone (tumour size, grade, clinical risk category) are shown to be prognostic only and insufficient to determine chemotherapy benefit3
  • Studies have shown that the Oncotype DX® test is predictive of chemotherapy benefit in HR+, HER2-, early-stage breast cancer1,2

In TAILORx, exploratory analyses were performed to evaluate whether subgroups may derive benefit from the addition of chemotherapy to endocrine therapy in patients with Recurrence Score results 11–253

a Clinical risk categorised according to Modified Adjuvant!Online Criteria: Low clinical risk defined by Grade 1 and tumour size ≤3 cm, Grade 2 and tumour size ≤2 cm, Grade 3 and tumour size ≤1 cm; high clinical risk defined as all other cases with known values for grade and tumour size3

The Oncotype DX test reduces risks of over- and undertreatment3

73% of patients with high clinical riska had Recurrence Score results 0–25 and may have been overtreated without the Recurrence Score result.3

High Clinical Risk Patients

Chemotherapy can potentially be spared

43% of patients with Recurrence Score results 26–100 had low clinical riska and may have been undertreated without the Recurrence Score result.3

Low Clinical Risk Patients

Chemotherapy can potentially be life-saving

a Low clinical risk defined by low grade and tumour size ≤3 cm, intermediate grade and tumour size ≤2 cm, and high grade and tumour size ≤1 cm; high clinical risk defined as all other cases with known values for grade and tumour size3

Guiding treatment based on Recurrence Score results and age

In an exploratory analysis, TAILORx showed that some patients may see benefit from the addition of chemotherapy based on a reduction in the likelihood of distant recurrence3,14


ABBREVIATIONS

CT = chemotherapy;
HER2– = human epidermal growth factor receptor 2 negative;
HR+ = hormone receptor positive;

REFERENCES
  1. Paik et al. J Clin Oncol. 2006.
  2. Geyer et al. NPJ Breast Cancer. 2018.
  3. Sparano et al. N Engl J Med. 2018.
  4. Barni et al. ESMO. 2018.
  5. Gligorov et al. Oncologist. 2015.
  6. Curtit et al. Breast. 2019.
  7. Barni et al EBCC. 2018.
  8. Battisti et al. EBCC. 2019.
  9. Petráková et al. St Gallen conference. 2019.
  10. Davidson et al. Eur J Cancer 2013.
  11. Levine et al. J Clin Oncol. 2015.
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