Oncotype DX Breast Recurrence Score

The Oncotype DX® test provides significant value in clinical practice

For node-negative, early breast cancer patients

The Oncotype DX Breast Recurrence Score test is the only one validated to predict chemotherapy benefit for your patients with HR+, HER2-, node-negative, early-stage, invasive breast cancer and hence to guide treatment decisions.1–3

TAILORx and NSABP B-20 results show that most patients do not benefit from chemotherapy2,3

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 substantial absolute benefit from the addition of chemotherapy to endocrine therapy1,3
  • An exploratory analysis suggests that some patients ≤50 years of age with Recurrence Score results 16–25 may benefit from chemotherapy2,16
Guiding treatment based on Recurrence Score results and age

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

a DRFI=distant recurrence-free interval
* Invasive disease–free survival defined as the first event of distant recurrence, local–regional recurrence, contralateral breast or other second primary cancer, or death without cancer recurrence
** Recurrence–free interval defined as all distant and local recurrences

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 impacted treatment decisions4-11
  • Clinical risk features alone (tumour size, grade, clinical risk category) are proven to be prognostic only and insufficient to determine chemotherapy benefit2

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 11–252

a Clinical risk categorized according to Modified Adjuvant!Online: 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 size

The Oncotype DX test reduces risks of over and undertreatment2

73% of patients with high clinical riska had Recurrence Score results 0–25 and may have been overtreated without the Recurrence Score result.2

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.2

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 size

The Oncotype DX Breast Recurrence Score assay is the standard of care to guide adjuvant treatment in HR+, HER2–, node negative, early-stage breast cancer patients

Since clinical risk features alone are not sufficient to determine CT benefit,2,15 the Oncotype DX Breast Recurrence Score test should be used for:

  • All patients for whom chemotherapy can potentially be spared
  • All patients for whom chemotherapy can potentially be life-saving
ABBREVIATIONS

CT = chemotherapy;
DRFI = distant recurrence-free interval;
ET = endocrine therapy;
HER2– = human epidermal growth factor receptor 2 negative;
HR+ = hormone receptor positive;
ITT = Intention-to-treat;
N+ = node-positive;
N0 = node-negative

REFERENCES
  1. Paik et al. J Clin Oncol. 2006.
  2. Sparano et al. N Engl J Med. 2018.
  3. Geyer et al. NPJ Breast Cancer. 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.
  12. Sparano and Paik. J Clin Oncol. 2008.
  13. Sparano et al. N Engl J Med. 2015.
  14. Blok et al. Cancer Treatment Reviews. 2018.
  15. Albanell et al. Eur J Cancer. 2016.
  16. Hochheiser. J Comp Eff Res. 2019.
  17. Bello et al. Ann Surg Oncc 2018.
  18. Sparano et al. N Engl J Med. 2019.

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