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Dec 28, 2017 12:51PM
Dec 28, 2017 02:29PM
Those with hormone receptor-positive, HER2-negative invasive breast cancer may receive the OncotypeDX test for invasive breast cancer.
All those receiving this particular test should be certain to obtain a complete copy of their original Oncotype test report for their review and records (not some partial information copied into a patient portal with risk of error). They should confirm their name on the report, the proper lymph node status, and all other material information.
The OncotypeDX test for invasive disease and the report content is designed for use in certain hormone-receptor positive, HER2-negative patients whose distant recurrence risk warrants a recommendation for 5-years of initial endocrine therapy under clinical consensus guidelines, and in whom chemotherapy would normally be considered or recommended based on clinical and pathologic criteria alone under clinical consensus guidelines. The results can further inform decisions about whether or not to add chemotherapy to endocrine therapy.
A patient may still elect to decline endocrine therapy, if they do not feel that the absolute benefits outweigh the risks in their particular case (based on a personalized risk/benefit analysis). However, it is important to understand that the reports do not include any estimate of risk without endocrine therapy.
The risk information in the reports is based on clinical trials in which all of the patients were assigned to 5-years of Tamoxifen (either 5 yrs of Tamoxifen Alone or 5 yrs of Tamoxifen plus Chemotherapy). Thus, the test is said to assume receipt of endocrine therapy as noted by pupmom.
If no endocrine therapy is received, a person's risk would be much higher than indicated in their report.
Your Medical Oncologist can provide an estimate of your risk with no endocrine therapy. The difference between your risk with endocrine therapy (after all other treatments) and your risk with no further treatment corresponds to the "absolute benefit" of therapy your case, which in turn should be weighed against the risks of side effects of treatment, in light of your personal risk tolerance.
The first graph in the node-negative report provides information about the average 10-year distant (metastatic) recurrence risk that is associated with your Recurrence Score (with Tamoxifen Alone). However, there are additional risks that are not included in this value, such as the additional risk of same in-breast recurrent or new disease, and the additional risk of new disease in the contralateral (opposite) breast. Endocrine therapy can reduce these risks as well, providing additional potential benefits. Therefore, you may also wish to request personalized estimates of these additional risks as well (a) with endocrine therapy; or (b) without endocrine therapy to better understand your overall risk/benefit profile from treatment.
Node-negative Report Content - Nature of Risk Information Provided with Endocrine Therapy (Tam) Alone
If a person has node-negative disease, then they would receive a node-negative Oncotype report.
The report title at the top of page 1 should indicate that it is a "Node Negative" report if you are node-negative:
Here is a screen shot of the first graph from the current node-negative sample report on-line (found here). It illustrates the results for person with a Recurrence Score of 10, which is associated with a 10-year Risk of Distant Recurrence of 7% (95% CI: 4% - 9%) with Tam Alone (see graph and printed risk information to the left of the graph):
Reading off the graph of this node-negative report, a Recurrence Score of 9 would be associated with a 10-year Risk of Distant Recurrence of around 6% with Tam Alone (i.e, WITH Tamoxifen treatment). Please check the actual content of your report for the precise numbers printed to the left of the first graph.
The first graph showing the relationship between 10-year distant recurrence risk and Recurrence Score comes from Figure 4 of Paik (2004), a study of patients who were all assigned to receive 5-years of Tamoxifen. Therefore, the 10-year distant recurrence risk without any endocrine therapy would be higher than indicated next to the first graph of your report.
If no endocrine therapy is received, a person's risk would be much higher than indicated in the report. Please obtain an estimate of your risk(s) without endocrine therapy from your medical oncologist.
Tamoxifen or an Aromatase Inhibitor:
Although the reports for the Oncotype test for invasive disease currently feature "validation" studies in which Tamoxifen was used, this reflects historical and practical considerations of clinical trial design. In current clinical practice, the use of Oncotype Recurrence Score information does NOT restrict choice of endocrine therapy. Thus, patients receiving the Oncotype test for invasive disease should receive a case-specific recommendation for endocrine therapy that is appropriate to their particular situation (e.g., Tamoxifen, an Aromatase Inhibitor).
For example, here is a later Oncotype validation study conducted in patients who had received 5-years of the aromatase inhibitor Anastrozole. This study used samples and 9-yr recurrence rates from the tamoxifen arm and the anastrozole arms of the ATAC trial, in node-negative and node-positive postmenopausal women with localized breast cancer.
>> "Prediction of Risk of Distant Recurrence Using the 21-Gene Recurrence Score in Node-Negative and Node-Positive Postmenopausal Patients With Breast Cancer Treated With Anastrozole or Tamoxifen: A TransATAC Study"
>> Dowsett (2010): http://jco.ascopubs.org/content/28/11/1829.full.pdf
In addition, the prospective TAILORx trial, in node-negative (N0), hormone receptor-positive, HER2-negative disease, permits a variety of endocrine therapies. The 5-year results for those with Recurrence Scores of 0 to 10 assigned to receive endocrine therapy alone were reported here:
>> "Prospective Validation of a 21-Gene Expression Assay in Breast Cancer"
>> Sparano (2015): http://www.nejm.org/doi/full/10.1056/NEJMoa1510764#t=article
>>QUOTE: "In the low-risk cohort of 1626 patients, endocrine therapy included an aromatase inhibitor in 963 patients (59%), tamoxifen in 560 (34%), sequential tamoxifen followed by aromatase-inhibitor therapy in 13 (1%), ovarian-function suppression in 44 (3%), or other or unknown therapy in 46 (3%)."
Thus, if post-menopausal (as defined in the NCCN guidelines for breast cancer), then another point of discussion would be the option of an Aromatase Inhibitor ("AI"), which may provide some advantage over Tamoxifen, particularly for those with Invasive Lobular Carcinoma ("ILC") (see e.g., Filho (2015).
The AIs (Letrozole (FEMARA); Anastrozole (ARIMIDEX); or Exemestane (AROMASIN)) have different drug-drug interaction profiles from Tamoxifen, and different side effect profiles from Tamoxifen. Such differences can affect recommendations. You can request information about side effects and their incidence, and whether you may be at increased risk of certain side effects in view of your personal medical history (e.g., co-morbidities) or family medical history.
Given the above, any post-menopausal woman who receives a recommendation for Tamoxifen should request a reasoned explanation of why Tamoxifen is preferable to an Aromatase Inhibitor in her particular case (and seek a second opinion if it is suggested that reliance upon the oncotype test restricts her choices.)
I am a layperson with no medical training, so please confirm all information above with your Medical Oncologist to ensure receipt of current, case-specific expert professional medical advice.
Stage IA IDC, 9/2013 BMX. Right: IDC (1.5 mm, grade 2) with DCIS (5+ cm), 0/4 nodes, pN0. Left: DCIS (5+ cm), 0/1 node, pN0(i+).