A solid body of evidence validates prediction of chemotherapy benefit
The Oncotype DX Breast Recurrence Score® test is the only genomic test with Level 1 evidence for prognosis and prediction of chemotherapy benefit in patients with early-stage, hormone receptor-positive, invasive breast cancer.4,6-8
Clinical validation studies
In total, 4 validation studies—involving nearly 3,000 patients—have been performed. The studies showed that the Oncotype DX® test is4,6-8:
- Strongly associated with the rate of distant recurrence
A low Recurrence Score® result indicates a significantly lower rate of distant recurrence and a lower likelihood of chemotherapy benefit6,7
- Predictive for likelihood of benefit from chemotherapy
A high Recurrence Score® result indicates a higher rate of distant recurrence and predicts a significant benefit from chemotherapy4,8
TAILORx Trial1-4 |
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10,273 patients Recurrence Score results
N0 patients can safely forgo chemotherapy |
RxPONDER Trial5,9-11 |
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5,083 patients Recurrence Score results
Postmenopausal N1 patients do not benefit from chemotherapy |
Proven to help patients with a low Recurrence Score result avoid chemotherapy
Several separate studies, with a total of more than 63,000 patients, found that patients with a low Recurrence Score result may be effectively treated with hormonal therapy alone and safely spared chemotherapy.1,12-18
STANDARD OF CARE
With prospective outcomes in over 100,000 patients—including over 12,000 node-positive patients2,4-8,19-22
PROVEN
To be predictive of chemotherapy benefit in both node-positive and node-negative patients4,8
CLINICALLY VALIDATED
In multiple studies with consistent results (level 1 evidence for risk of distant recurrence and prediction of chemotherapy benefit)2,4-8
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References