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:
The Oncotype DX Breast
Recurrence® test provides
significant value in clinical practice
Recurrence® test provides
significant value in clinical practice
Node-Negative
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
The Oncotype DX test can help reduce risks of over- and undertreatment2
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.2
Low clinical risk patients
43% of patients with Recurrence Score results 26–100 had low clinical riska and may have been undertreated without the Recurrence Score result.2
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
Proven clinical utility of the Oncotype DX assay1-3,13,16
Adjuvant chemotherapy may now be guided with an unprecedented level of evidence and precision using the Oncotype DX Breast Recurrence Score test to identify:
the vast majority of patients who can safely be spared chemotherapy
the important minority for whom chemotherapy may be life-saving
Standard of care
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:
References
- Paik et al. J Clin Oncol. 2006.
- Sparano et al. N Engl J Med. 2018.
- Geyer et al. NPJ Breast Cancer. 2018.
- 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.
- Sparano and Paik. J Clin Oncol. 2008.
- Sparano et al. N Engl J Med. 2015.
- Blok et al. Cancer Treatment Reviews. 2018.
- Albanell et al. Eur J Cancer. 2016.
- Hochheiser. J Comp Eff Res. 2019.
- Bello et al. Ann Surg Oncc 2018.
- Sparano et al. N Engl J Med. 2019.
Node-Positive
For node-positive, early-stage HR+ HER2- breast cancer patients
The Oncotype DX Breast Recurrence Score® result is predictive of chemotherapy benefit in your postmenopausal patients with HR+, HER2-, node-positive (1-3 positive nodes), early-stage, invasive breast cancer as demonstrated by the SWOG-8814 study.1 Data from SWOG-8814 and the RxPONDER randomized prospective trial show that a substantial proportion of these patients can be spared chemotherapy.1,7
CT benefit expressed in percentage points based on probability of distant recurrence (N0) or distant recurrence-free interval (N1) with/without CT at 5 years. No CT benefit is considered for an absolute benefit <1%.
*The benefit of chemotherapy for premenopausal N1 patients with RS® results 26-100 has not been formally assessed in a randomized 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.
Challenging Node-Positive Cases - Drs. Jeremy Force and Christy Russell
How can 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. RxPONDER study results added to the findings of SWOG 8814 by providing a refined estimate of CT benefit in N1 patients with the following results6-7:
- N1 postmenopausal patients with Recurrence Score® results 0-25 may be spared chemotherapy, regardless of the number of affected nodes, tumour grade or size26-7.
- N1 premenopausal patients with Recurrence Score results 0-25 derive a 2.4% benefit from chemotherapy based on distant recurrence-free interval at 5 years6-7.
Use of the Oncotype DX test may reduce the risk of overtreatment with chemotherapy in node-positive HR+, HER2- early-stage breast cancer1,6-7
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
Clinical utility of the Oncotype DX assay
In summary, adjuvant chemotherapy may be guided with the Oncotype DX test to identify the majority of node-positive patients (with up to 3 positive nodes) who will not benefit from the addition of chemotherapy.1,6-7
The Oncotype DX Breast Recurrence Score* test should be used for:
- All patients for whom chemotherapy may be spared
- All patients for whom chemotherapy may be life-saving
*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
RS=Recurrence Score result
References
- Albain et al. Lancet Oncol. 2010.
- Stemmer et al. NPJ Breast Cancer. 2017.
- Hortobagyi et al. SABCS. 2018.
- Bello et al. Ann Surg Onc. 2018.
- Nitz et al. Breast Cancer Res Treat. 2017.
- Kalinsky et al. SABCS 2021 GS2-07.
- Kalinsky et al. N Eng J Med. 2021
- Allemani et al. Int J Cancer. 2013.
- Zhang et al. Breast Can Res Treat. 2020.
- Tonellotto et al. Eur J Breast Health. 2019.
- Chen et al. Ann Surg Onc. 2007.
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