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DR GONZALEZ-ANGULO: This is like a second Oncotype but for DCIS. It’s a little different because it doesn’t take into consideration the entire 21 risk Recurrence Score. It actually takes into consideration the 12 genes, five of them are control genes. So I think that the stronger predictor for these scores are basically the proliferation genes. So it’s based on an ECOG study in which patients that had DCIS were not treated with radiation therapy. And what they did is, they applied these 12-gene scores to them and they use it as a continuous variable and they split it into three risk categories with the score from 1 to 100, different cutoffs than the standard 21-gene Recurrence Score — so it was 39, 55 and above 55.

And what they were able to show was two things. The primary endpoint was ipsilateral event. An event could be an invasive tumor or other DCIS. And what they saw was basically that the patients that had the highest score were more likely to have more ipsilateral events, and when they looked at basically invasive events, it was a little bit more.

Now what was interesting is that in those patients that had a high-risk score, about 20 percent of them had an invasive recurrence. So maybe — and this is all hypothesis generating, this is something that needs to be validated in independent set if possible or in a prospective way — but maybe those are the patients that truly benefit from some more local control, ie, radiation therapy.

DR LOVE: Terry, what did you think about that study? Are there any situations right now — because it is available I understand — where you would order on a patient with DCIS?

DR MAMOUNAS: Yes. I mean this was studied, as Ana Maria described, that it was a selected group of patients that were treated with no radiotherapy, mostly Grade I and II less than 2.5 centimeters, and Grade III less than 1 centimeter with wide margins of excision, but a third got tamoxifen. And this study essentially showed that for the low-intermediate Recurrence Score patients you can select a group that can be appropriate with no radiotherapy.

The bottom line is that you would use it, but you also have to take into account your other factors. Because a Recurrence Score — let’s say, a DCIS score of 20, which indicates low risk, in a patient that’s 40 years old and has 2-centimeter DCIS may not give you the same outcome as that in a patient that has a 6-millimeter tumor and is 65. So you have to take into account — like what we did for invasive cancer with RSPC — still anatomic and biologic factors like age and tumor size.