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About Oncotype DX

The Role of Oncotype DX

Assessing Recurrence
Chemotherapy Benefit
Quantitative ER and PR Scores

Oncotype DX Studies

Oncotype DX Logistics

Clinical Practice Guidelines

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The TAILORx Clinical Trial

Frequently Asked Questions


Updated NCCN Guidelines

Healthcare Insurance


Chemotherapy Benefit

In addition to quantifying breast cancer recurrence risk, Oncotype DX® also assesses the benefit from chemotherapy.1 While adjuvant chemotherapy is an important part of the care of breast cancer patients, a major challenge in oncology has been to better define the risk/benefit ratio for candidates of adjuvant chemotherapy. By characterizing an individual's risk of recurrence and responsiveness to treatment, Oncotype DX can provide authorized healthcare providers with the information they need to develop a treatment plan tailored to the individual patient.

The ability of the Oncotype DX assay to predict the treatment benefit in breast cancer was demonstrated in a study of 651 eligible patients from the tamoxifen alone arm (n = 227) and tamoxifen plus chemotherapy treatment arm (CMF/MF) (n = 424) of NSABP Study B-20. Results showed that the Recurrence Score ® (RS) is a significant predictor of chemotherapy benefit (p-value for interaction = 0.038) and that not all patients benefit equally from chemotherapy:

  • Patients with tumors that had low Recurrence Scores (RS < 18) derived minimal, or no benefit from chemotherapy
  • Patients with tumors that had high Recurrence Scores (RS ≥ 31) had a large absolute benefit from chemotherapy

The Oncotype DX assay is recommended by the Updated ASCO Clinical Guidelines for Use of Tumor Markers in Breast Cancer to identify:

  • Node-negative, ER-positive breast cancer patients who may not benefit from adjuvant chemotherapy (specifically CMF/MF) because of their low risk of recurrence2
  • Node-negative, ER-positive breast cancer patients who may derive significant benefit from adjuvant chemotherapy (specifically CMF/MF) because of their high risk of recurrence2


ASCO Guidelines also noted that "there are insufficient data at present to comment on whether the conclusions [about the utility of Oncotype DX] generalize to hormonal therapies other than tamoxifen, or whether this assay applies to other chemotherapy regimens."

In addition to ASCO, the NCCN updated its Clinical Practice Guidelines in Oncology Breast Cancer to include the use of the Oncotype DX test for subgroups of patients with node-negative, ER positive breast cancer to guide treatment decisions with respect to hormonal therapy and chemotherapy.


Oncotype DX in Node Positive Breast Cancer

Presented at the 2007 San Antonio Breast Cancer Symposium, results from SWOG 88144, Prognostic and Predictive Value of the 21-Gene Recurrence Score Assay (n=367), demonstrate that the Oncotype DX Recurrence Score is informative for post-menopausal patients with node positive, HR-positive breast cancer:
  • Oncotype DX is a prognostic test for disease-free survival at 10 years
  • Oncotype DX is a predictive test for chemotherapy benefit (CAF) - change in disease free survival increase in disease-free survival.

Please note: The endpoint for this study was time to recurrence (local or distant), new primary breast cancer, or death from any cause. This is different from the endpoint in the studies of node negative, ER-positive patients which incldued only distant recurrence.
The report now includes results from the NSABP B-20 study of chemotherapy benefit(CMF/MF) according to the Recurrence Score for node negative, estrogen receptor positive patients and results from the SWOG 8814 study of prognosis and chemotherapy benefit(CAF) for node positive, hormone receptor positive post-menopausal patients.

For a Sample Node Negative Report, please click here. For a Sample Node Positive Report, please click here.




1 The data on chemotherapy benefit is derived from the NSABP Study B-20 which compared hormonal therapy alone versus CMF based chemotherapy and hormonal therapy.
2 Harris L., Fritsche H., Mennel R., et al; American Society of Clinical Oncology 2007 Update of Recommendations for the Use of Tumor Markers in Breast Cancer, published ahead of print on October 22, 2007 as 10.1200/JCO.2007.14.2364
3 National Comprehensive Cancer Network 2008 Clinical Practice Guidelines in Oncology, Breast Cancer
4 Albain K, Barlow W, Shak S, Hortobagyi G., et al; Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal, node-positive, ER-positive breast cancer (S8814, INT0100). Presented at: The 2007 San Antonio Breast Cancer Symposium. December 13-16, 2007. San Antonio, Texas. Abstract #10









 

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