Moving from assumed to proven chemotherapy benefit - the clarity every patient deserves

The Oncotype DX Breast Recurrence Score^® test was developed to help guide chemotherapy treatment decisions based on the prediction of chemotherapy benefit. By revealing tumour biology beyond clinical-pathological parameters, it shifts decision-making from assumed to proven chemotherapy benefit for your HR+, HER2- early-stage breast cancer patients.^1-5

Predictive parameters help guide treatment decisions^{1-2,4,6,12-14}

Predictive markers can inform treatment decisions and avoid extrapolation from prognostic factors.⁶ Predictive markers such as ER and HER2 status identify patients responding to hormonal treatment and trastuzumab, respectively. The Recurrence Score^® result informs whether a tumour is likely to respond to chemotherapy. The NSABP B-20 and SWOG 8814 studies established the predictive value of the Recurrence Score^® result and the TAILORx study refined the estimates of chemotherapy benefit, identifying two groups of patients:^1-3,7-11

1. Those who do not benefit from the addition of chemotherapy to endocrine therapy, a majority of early breast cancer patients.
2. Those with Recurrence Score^® results 26-100 who are most likely to derive substantial benefit from the addition of chemotherapy to endocrine therapy.

Predictive markers can inform treatment decisions^{1-2,4,6,12-14}

The Oncotype DX^® test identifies two groups of node-negative patients based on prediction of chemotherapy benefit^1-3,7-11

* HR+, HER2-, node-negative, early-stage, invasive breast cancer
a do not benefit from the addition of chemotherapy to endocrine therapy
b significantly benefit from the addition of chemotherapy to endocrine therapy

Prognostic parameters alone cannot guide treatment decisions with precision^2,5,15-20

In clinical practice, treatment decisions are often made based on prognostic factors such as tumour size and grade². However, such clinical-pathological parameters are prognostic and have not been demonstrated to predict chemotherapy benefit.^2,5,15 Furthermore, several studies have established that clinical-pathological features cannot predict Recurrence Score^®results.^2,16-20

Clinical-pathological characteristics do not predict the Recurrence Score^® results in TAILORx²

a Patients with unknown values were excluded from the analysis
b Low clinical risk:
tumour size ≤3 cm and Grade 1;
tumour size ≤2 cm and Grade 2;
tumour size ≤1 cm and Grade 3
High clinical risk: all other cases with known values for grade and tumour size

Clinical-pathological features alone cannot predict the Recurrence Score^® results in clinical practice¹⁶

b Low clinical risk:
N0, T ≤3 cm and Grade 1
N0, T ≤2 cm and Grade 2
N0, T ≤1 cm and Grade 3
N1, T ≤2 cm and Grade 1
High clinical risk: all other cases

Moreover, relying on these clinical-pathological factors alone was shown to be associated with a high level of uncertainty amongst physicians regarding their treatment decisions. Testing with the Oncotype DX^® assay provided greater confidence to clinicians in their treatment recommendations as reflected in a recent case study.¹⁷

Uncertainty about treatment decisions based on clinical-pathological features alone¹⁷

The Oncotype DX^® test can be used to reduce the risk of over- and undertreatment with chemotherapy^2,18

The value of the Oncotype DX^® test for your HR+, HER2-, node-negative, early-stage breast cancer patients is exemplified by data from the TAILORx trial showing that the Oncotype DX^® test aids in the identification of patients who are at risk of over- or undertreatment if clinical pathologic factors alone are used to guide treatment decisions.^2,18 Numerous decision-impact studies carried out worldwide in which clinicians accounted for all clinical-pathological features, confirm this potential to reduce the risk of over- or undertreatment with chemotherapy.^2,18-21

The Oncotype DX^® test reduces the risk of over- and undertreatment^2,18

a Low clinical risk: tumour size ≤3 cm and Grade 1; tumour size ≤2 cm and Grade 2; tumour size ≤1 cm and Grade 3
High clinical risk: all other cases with known values for grade and tumour size
b Assuming that adjuvant chemotherapy would have been prescribed or not based on clinical risk.

Decision-impact studies confirm the potential to reduce over- and undertreatment as suggested by TAILORx^2,19-21

a Percentage of patients initially recommended CT-HT based on all clinical-pathological parameters and de-escalated to HT alone based on RS^® result
b Percentage of patients initially recommended HT based on clinical-pathological parameters and escalated to CT-HT based on RS^® result
c Patients with unknown values were excluded from the analysis

International guidelines and health technology assessment bodies provide recommendations on whom to test^22-26

International guidelines (NCCN, St. Gallen, ASCO)^22-24 and health technology assessment (HTA) bodies (IQWIG, NICE)^25-26 recognise the Oncotype DX^® test for its value in clinical decision-making. Furthermore, they provide guidance on whom to test. The NCCN guidelines recommend to strongly consider all pre- and postmenopausal N0 patients with a tumour size >0.5cm for testing as well as all postmenopausal N1 (1-3 positive nodes) patients²², whereas the German HTA body IQWIG recommends testing all N0 patients when there is treatment uncertainty based on clinical risk assessment²⁵:

a As voted by a clear majority of the St Gallen International Expert Consensus panel