Understanding Results | Oncotype DX Test

The Oncotype DX Breast Recurrence Score^® report provides three points of clarity to aid in treatment decisions as to whether adjuvant chemotherapy is needed or not for node-negative and node-positive (N1: up to 3 positive lymph nodes), hormone receptor-positive, HER2-negative, early-stage breast cancer patients.

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This number, between 0 and 100, is calculated by measuring the activity of specific genes in the breast cancer tissue. The Recurrence Score result is used to predict the risk of the breast cancer returning at a distant site and whether chemotherapy may help reduce the risk.1-5

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This percentage indicates the risk that the breast cancer will come back somewhere else in the body, “distant recurrence,” within 10 years (node-negative)1,6 or 5 years (node-positive)4,9,10 when treated with hormonal therapy alone for 5 years.

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This percentage indicates the benefit expected for the Recurrence Score group from adding chemotherapy to hormonal therapy in order to reduce the risk of cancer recurrence or death.2-4, 8-10

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These results are valid in HR+, HER2-, early-stage, invasive breast cancer patients treated with 5 years of endocrine therapy.

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Node-Negative

	Accounting for Age
	The report is stratified by age - ≤50 years and >50 years

	Recurrence Score result
	The Recurrence Score result is based on the quantitative analysis of the expression of 21 genes within the patient’s tumour sample. This number, from 0 to 100, is used to determine distant recurrence risk at 10 years (prognosis) and absolute chemotherapy benefit (prediction).

	Prognosis
	Your patient’s individualised 10-year distant recurrence risk (%) with endocrine therapy alone.* *Based on the TAILORx or NSABP B-14 clinical trial populations

	Prediction
	The absolute chemotherapy benefit (%) is based on the average benefit of chemotherapy in patients who had the same range of Recurrence Score results.* *Based on the TAILORx or NSABP B-20 clinical trial populations

	Single-Gene Scores
	Quantitative ER, PR, and HER2 scores by RT-PCR, specific to your patient.

	Clinical trial description
	Contains relevant study details from NSABP B-14, NSABP B-20 or TAILORx. For patients ≤50 years with Recurrence Score results 16-25 this section also contains information on chemotherapy benefit stratified by clinical risk

Additional study information

Displays the patient’s individualized Recurrence Score® result in the context of the relevant study data from either TAILORx trial or the NSABP B-20 trial. This example is for a patient over 50 years of age and shows the difference in the 10-year risk of distant recurrence when a patient with a Recurrence Score result of 20 is treated with chemotherapy and endocrine therapy vs endocrine therapy alone.

For all ages and Recurrence Score results 51-100, the data is only available for the group. Therefore the graph from NSABP B-20 Recurrence Score results 0-50 is shown for information only.

	Data Details
	Details regarding the data used to report distant recurrence risk and absolute chemotherapy benefit, including clinical trial characteristics, sample sizes, and confidence intervals.

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Node-Positive

	Menopausal State
	Now includes the patient’s menopausal status

	Recurrence Score Result
	The Recurrence Score result is based on the quantitative analysis of the expression of 21 genes within the patient’s tumour sample.

	Prognosis
	Patient’s individualised risk of distant recurrence or individualised risk of recurrence or mortality when treated with endocrine therapy alone.* *Based on the RxPONDER trial or the SWOG-8814 study.

	Prediction
	The Group Average Absolute Chemotherapy Benefit is the potential reduction in distant recurrence risk across all ages within this range of Recurrence Score® results when chemotherapy is added.* *Based on the RxPONDER clinical trial populations.

	Confidence Interval Range
	The 95% confidence intervals provide the likely range of values for these measures.

	Single-Gene Scores
	Quantitative ER, PR, and HER2 scores by RT-PCR, specific to your patient.

	Study Details
	Contains relevant study details from either the RxPONDER trial or SWOG-8814.

	Additional Study Information
	Displays the patient’s individualized Recurrence Score^® result in the context of the relevant study data from either RxPONDER trial or the SWOG-8814. This example shows the difference in the 5-year risk of distant recurrence when a patient with a Recurrence Score result of 12 is treated with chemotherapy and endocrine therapy vs endocrine therapy alone.

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Patients with a Recurrence Score result of 0-25 generally do not benefit from the addition of chemotherapy to endocrine therapy.2,3,6,7

For patients under 50 years of age or yonger there is some chemotherapy benefit (in terms of DRFI) for those with Recurrence Score result:6,7

16-20 and high clinical risk
21-25 regardless of clinical risk

Patients with Recurrence Score results 26–100 have a significant and increasing benefit from the addition of chemotherapy to endocrine therapy.2,3

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Post-menopausal patients with a Recurrence Score result of 0–25 do not benefit from the addition of chemotherapy to endocrine therapy.4,9,10

Pre-menopausal patients with Recurrence Score results of 0-25 have a 2.4% benefit (in terms of DRFI) from the addition of chemotherapy to endocrine therapy.9,10

All patients with Recurrence Score results 26-100 significantly benefit from the addition of chemotherapy to endocrine therapy.4

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Abbreviations

CT, chemotherapy

ER, estrogen receptor

ET, endocrine therapy

HER2, human epidermal growth factor receptor 2

N1, node-positive

DRFI, Distance Recurrence-Free Interval

References

Paik et al. N Engl J Med. 2004.
Paik et al. J Clin Oncol. 2006.
Geyer et al. NPJ Breast Cancer. 2018.
Albain et al. Lancet Oncol. 2010.
Dowsett et al. J Clin Oncol. 2010.
Sparano et al. N Engl J Med. 2018.
Sparano et al NEJM Evidence 2024
Exact Sciences. Data on file
Kalinsky et al. NEJM. 2021.
Kalinsky et al. SABCS 2021.

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Have questions about Oncotype DX^®?

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Interpreting the results

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3 pieces of information provided by the test

Recurrence Score^® result

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Distant recurrence risk^a

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Absolute chemotherapy benefit^a

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Explore the patient reports

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Abbreviations

References

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Recurrence Score^® result

Distant recurrence risk^a

Absolute chemotherapy benefit^a

References

Interpreting the results

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3 pieces of information provided by the test

Recurrence Score® result

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Distant recurrence riska

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Absolute chemotherapy benefita

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Explore the patient reports

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Abbreviations

References

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Recurrence Score® result

Distant recurrence riska

Absolute chemotherapy benefita

References

Recurrence Score^® result

Distant recurrence risk^a

Absolute chemotherapy benefit^a

Recurrence Score^® result

Distant recurrence risk^a

Absolute chemotherapy benefit^a