The value of the Oncotype DX Breast
Recurrence® test in clinical practice
Recurrence® test in clinical practice
Node-Negative
For node-negative, early-stage 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 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 help guide treatment decisions?
Clinical evidence has demonstrated:
- Patients with Recurrence Score® results 0–25 do not benefit 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 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 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
High clinical risk patients
73% of patients with high clinical riska had Recurrence Score results 0-25 and may have been overtreated without the Recurrence Score result.3
Chemotherapy can potentially be spared
Chemotherapy can potentially be spared
Low clinical risk patients
43% of patients with Recurrence Score results 26-100 had low clinical riska
and may have been undertreated if without the Recurrence Score result.3
Chemotherapy can potentially be life-saving
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
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
Clinical Utility of the Oncotype DX® Assay1-3,13
Adjuvant chemotherapy may now be guided with the highest level of evidence (level 1A) and precision using the Oncotype DX Breast Recurrence Score® test to identify:
the vast majority of patients with no chemotherapy benefit1-3, 14
the important minority for whom chemotherapy may be life-saving1-3, 14
Abbreviations
CT = chemotherapy;
HER2– = human epidermal growth factor receptor 2 negative;
HR+ = hormone receptor positive;
References
- Paik et al. J Clin Oncol. 2006.
- Geyer et al. NPJ Breast Cancer. 2018.
- Sparano and Paik. J Clin Oncol. 2008.
- Barni et al. ESMO. 2018.
- Gligorov et al. Oncologist. 2015.
- Curtit et al. Breast. 2019.
- Barni et al EBCC. 2018.
- Battisti et al. EBCC. 2019.
- Petráková et al. St Gallen conference. 2019.
- Davidson et al. Eur J Cancer 2013.
- Levine et al. J Clin Oncol. 2015.
Node-Positive
For node-positive, early-stage breast cancer patients
The Oncotype DX Breast Recurrence Score result is predictive of chemotherapy benefit for your postmenopausal patients with HR+, HER2-, node-positive (1-3 positive nodes), early-stage, invasive breast cancer as demonstrated by SWOG-8814.1 Data from SWOG-8814 and RxPONDER show that a substantial proportion of these patients may be spared chemotherapy.6
CT benefit expressed in percentage points based on probability of distant recurrence with/without CT at 5 years. No CT benefit is considered for an absolute benefit <1%.
*Benefit of chemotherapy for premenopausal N1 patients with RS® results 26-100 has not been formally assessed in a randomised study. The benefit derived from chemotherapy was significant for RS® results 0-13 and 14-25 in the RxPONDER study and it is inferred to be substantial for patients with RS® 26-100.
*Benefit of chemotherapy for premenopausal N1 patients with RS® results 26-100 has not been formally assessed in a randomised study. The benefit derived from chemotherapy was significant for RS® results 0-13 and 14-25 in the RxPONDER study and it is inferred to be substantial for patients with RS® 26-100.
How does the Oncotype DX test help guide treatment decisions?
SWOG 8814 study established the Oncotype DX® test as predictive of CT benefit in node-positive postmenopausal patients1. Initial results from the RxPONDER study add to the findings of SWOG 8814 by providing a refined estimate of CT benefit in N1 patients with the following results6:
- N1 postmenopausal patients with Recurrence Score® results 0-25 may be spared chemotherapy, independent of clinical pathological parameters.6.
- N1 premenopausal patients with Recurrence Score results 0-25 derive a 2.9% benefit from chemotherapy in terms of distant recurrence as first site at 5 years6.
Use of the Oncotype DX test may reduce the risk of overtreatment with chemotherapy1,6
A large proportion7-8 of HR+, HER2-, node-positive postmenopausal patients receive chemotherapy as N1 disease is considered high clinical risk due to worse prognosis9. Average chemotherapy treatment rates without genomic testing are in the range of 70% for this patient population7-8. RxPONDER demonstrated that many of these patients may be overtreated6, and the Oncotype DX test can help make informed treatment decisions.
N1
Nodal status, despite being of prognostic value, does not predict the Recurrence Score result and the underlying tumour biology4
Overall, 566,438 tumour specimens with known nodal status were
examined by the Genomic Health laboratory (now Exact Sciences) from
February 2004 to August 20174
examined by the Genomic Health laboratory (now Exact Sciences) from
February 2004 to August 20174
Clinical utility of the Oncotype DX assay
In summary, adjuvant chemotherapy may be guided with the Oncotype DX test to identify a significant proportion of node-positive patients (with up to 3 positive nodes) who may not benefit from the addition of chemotherapy.1,6
The Oncotype DX Breast Recurrence Score* test should be used for:
- All patients for whom chemotherapy can potentially be spared1,6
- All patients for whom chemotherapy can potentially be life-saving1,6
*For early stage, HR+, HER2- patients with up to 3 nodes involved
Abbreviations
CT = chemotherapy;
HER2– = human epidermal growth factor receptor 2 negative;
HR+ = hormone receptor positive;
LN = lymph node;
N+ = node-positive;
N0 = node-negative;
N1mi = node-positive with micrometastases;
N1 = 1–3 positive nodes;
HER2– = human epidermal growth factor receptor 2 negative;
HR+ = hormone receptor positive;
LN = lymph node;
N+ = node-positive;
N0 = node-negative;
N1mi = node-positive with micrometastases;
N1 = 1–3 positive nodes;
References
- Albain et al. Lancet Oncol. 2010.
- Stemmer et al. NPJ Breast Cancer. 2017.
- Hortobagyi et al. SABCS. 2018.
- Dowsett M et al. J Clin Oncol. 2010.
- Bello et al. Ann Surg Onc. 2018.
- Sparano and Paik. J Clin Oncol. 2008.
- Sparano et al. N Engl J Med. 2015.
- Sparano et al. N Engl J Med. 2018.
- Nitz et al. Breast Cancer Res Treat. 2017.
- Battisti et al. EBCC. 2019.
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