Oncotype DX Results
A detailed report is generated for each patient, with assay results provided as
a Recurrence Score® (0-100). The report also provides ER and PR
Scores on the final page. The report includes Clinical Experience for women
with both node negative and node positive, ER-positive breast cancer.
Clinical Experience for women with node negative, ER-positive breast
cancer:
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Page 1 provides the correlation of the Recurrence Score (RS) with a specific
likelihood of distant recurrence at 10 years, presented as the average 10-year
distant recurrence rate for that RS in the clinical trial population. This
clinical trial population was treated with 5 years of tamoxifen. The likelihood
of distant recurrence at 10 years increases continuously with an increase in
RS.
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A new Page 2 of the report provides information on the relationship of the
Recurrence Score to chemotherapy benefit for node negative, ER-positive
patients, as assessed using specimens from the NSABP B-20 study (CMF/MF). This
information is shown in 2 formats: by individual Recurrence Score (difference
between rate of distant recurrence for Tam vs Tam + CMF/MF with corresponding
confidence intervals) and by Recurrence Score Group.
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Page 3 includes quantitative ER and PR scores, providing additional insight
into the biology of individual tumors. ER and PR are two of the genes measured
in the determination of the Recurrence Score result.+ ER Score as
measured by Oncotype DX® is a strong predictor of tamoxifen benefit.
While the Recurrence Score and corresponding Average Rate of Distant Recurrence
already reflect this effect of tamoxifen (in addition to the tumor’s
fundamental prognosis), the ER Score may allow you to assess the magnitude of
tamoxifen benefit that is incorporated in that Rate. In the fall of
2008, quantitative HER2 scores will be provided on the Oncotype DX report.
Clinical Experience for post-menopausal women with node positive,
HR-positive breast cancer:
The Oncotype DX assay was recently shown to be both prognostic and
predictive of chemotherapy benefit (CAF) in a cohort of post-menopausal women
with node positive, HR-positive breast cancer from the SWOG 8814 study. The
overall results from this study, which had a different endpoint – time to
recurrence (local or distant), new primary breast cancer, or death from any
cause – are now included in the node positive report.
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The node positive report contains an additional page which provides information
on the relationship of the Recurrence Score to both prognosis (rate of
recurrence or death for patients treated with tamoxifen alone) and chemotherapy
benefit (difference in the rate of recurrence or death for patients treated
with CAF-tamoxifen vs tamoxifen alone) for node positive, HR-positive
post-menopausal patients, as assessed using specimens from the SWOG 8814 study.
The Oncotype DX assay report is sent by fax, overnight mail, or
secure online transfer to the treating physician (or other authorized
healthcare provider) and submitting pathologist. To view a sample report form
that explains the information provided and allows you to enter different
Recurrence Scores to see how they correlate with recurrence risk, click on the
image below. Please note, the interactive report demonstrates only the first
page of the report, which focuses on prognostic information for the
node-negative, ER-positive population.
Oncotype DX Sample Report Form
Node Negative Report Node Positive Report
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