Guiding Breast Cancer Treatment | Oncotype DX® Test

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Node-Negative

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 cancer^1-2 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 therapy^1-3

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Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - TAILORx and NSABP B-20 results show that most patients do not benefit from chemotherapy.

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Clinical evidence has demonstrated:

Patients with Recurrence Score^® results 0–25 do not benefit from the addition of chemotherapy to endocrine therapy^1-3
Patients with Recurrence Score results 26–100 as a group derive a 26% absolute benefit from the from the addition of chemotherapy to endocrine therapy^1,2
Exploratory analysis from TAILORx suggests that some patients ≤50 years of age with Recurrence Score results 16–25 may benefit from chemotherapy^3,14

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In multiple decision impact studies worldwide, the Oncotype DX Breast Recurrence Score^® test significantly affected treatment decisions^4-12
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 cancer^1,2

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

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Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - Exploratory analyses - No benefit from the addition of chemotherapy to endocrine therapy in patients with Recurrence Score results 11–25.

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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

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High clinical risk patients

73% of patients with high clinical risk^a had Recurrence Score results 0-25 and may have been overtreated without the Recurrence Score result.³

Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - can help reduce risks of over- and undertreatment in high and low clinical risk patients.

Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - can help reduce risks of over- and undertreatment in high and low clinical risk patients.

Chemotherapy can potentially be spared

Low clinical risk patients

43% of patients with Recurrence Score results 26-100 had low clinical risk^a and may have been undertreated if without the Recurrence Score result.³

Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients - can help reduce risks of over- and undertreatment in high and low clinical risk patients.

Chemotherapy can potentially be life-saving

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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

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 recurrence^3,14

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Oncotype DX value in clinical practice for node-negative, early-stage breast cancer patients -TAILORx analysis - Guiding Treatment based on Recurrence Score Results and Age.

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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.

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Node-Positive

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

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Oncotype DX value in clinical practice for node-positive, early-stage breast cancer patients - standard of care to guide adjuvant treatment in HR+, HER2–, early-stage breast cancer patients.

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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.

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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.

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A large proportion^7-8 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 population^7-8. RxPONDER demonstrated that many of these patients may be overtreated⁶, and the Oncotype DX test can help make informed treatment decisions.

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Nodal status, despite being of prognostic value, does not predict the Recurrence Score result and the underlying tumour biology⁴

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Distribution of Recurrence Scores by Nodal Status.

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

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 spared^1,6
All patients for whom chemotherapy can potentially be life-saving^1,6

*For early stage, HR+, HER2- patients with up to 3 nodes involved

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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;

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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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Have questions about Oncotype DX^®?

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Value in clinical practice

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Abbreviations

References

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N1

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Abbreviations

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References

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References

N1

Abbreviations

References