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Jan 15, 2017 11:58AM
Jan 15, 2017 02:20PM
Regarding the confusing reference above to a "high intermediate range per the Oncotype testing" in reference to a person with a Recurrence Score of 22, please note the following.
The standard risk category ranges for the OncotypeDX test for invasive disease (in node-negative or node-positive disease) based on various validation studies in these groups, are and have always been as follows:
Low-risk: Recurrence Score < 18 (i.e., 0 to 17)
Intermediate-risk: Recurrence Score 18 to 30
High-risk: Recurrence Score ≥ 31 (i.e., 31 to 100)
For links to numerous scientific publications setting forth these standard ranges, see this post:
A Recurrence Score of 22 would be in the lower half of the standard intermediate range of 18 to 30:
Secondly, it is appropriate to consider a variety of additional clinical and pathologic factors with an intermediate Recurrence Score of 18 to 30, as indicated on the Genomic Health web site (scroll down to list of factors):
Genomic Health: http://intermediate.oncotypedx.com/en-US/Using-The-Intermediate-Recurrence-Score/Integrating-The-Intermediate-Recurrence-Score.aspx
With regard to the potential benefit of chemotherapy, it is possible that there are differences within the intermediate range, such that chemotherapy benefit might differ by recurrence score or other factors. This is also discussed on the Genomic Health web site (scroll down):
Genomic Health: http://intermediate.oncotypedx.com/en-US/The-Recurrence-Score-Result/How-An-Intermediate-Recurrence-Score.aspx
For a more detailed discussion about the intermediate range, see this earlier post:
In connection with the question of added chemotherapy, the intermediate range is an area where a judgment call must be made in view of all relevant factors, as well as the personal risk tolerance of the patient. While additional gene expression profile testing may be considered, such secondary testing is not always recommended and appears to be less common outside of the United States. (From her date formatting, I suspect Vix lives elsewhere.)
It is possible that the confusion is based on certain investigational ranges being used in on-going clinical trials. In this regard, the prospective TAILORx trial in node-negative (N0) patients and the prospective RxPONDER trial in certain node-positive patients are using different investigational ranges, but they are still in progress.
Late in 2015, some preliminary results were published from the TAILORx trial in node-negative ("N0") patients scoring 0 to 10 who received endocrine therapy alone. These results showed that the test is quite robust in this sub-set of "low risk RS" patients (N0, RS 0 to 10). However, these results (from 0 to 10 only) did not operate to change the standard ranges. This is because they do not speak to outcomes for those with other scores (11 and above). We are still awaiting TAILORx trial results in its slightly differently defined investigational "intermediate" risk (RS 11 to 25) and investigational "high" risk (RS 26 and above) groups, so the standard ranges are still in effect (<18; 18 to 30; ≥31).
The on-going RxPONDER trial is still evaluating whether adjuvant chemotherapy is beneficial in patients with hormone receptor-positive, HER2-negative breast cancer with 1-3 positive lymph nodes and a Recurrence Score of 25 or less.
Of course, the investigational ranges reflect considerations of the magnitude of the recurrence risk associated with particular Recurrence Scores, and patients may wish to discuss this with their MOs.
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+).