DR RUGO: It’s always hard to balance, because those assays haven’t been compared to each other. I think both assays have shown a prognostic impact. We have the data in node-negative disease from the 21-gene Recurrence Score that’s, I think, quite compelling. And then I think that the 70-gene score, we’re going to have more information on trying to differentiate out ultralow versus medium low, ultrahigh versus medium high and that that information, in the long run, may help us further differentiate out benefit.

So at the moment, I think that both tests can be very useful in terms of assessing prognosis. The prediction of chemotherapy benefit in terms of dividing out the different groups for the 21-gene score is somewhat limited, just by that intermediate-risk group, where we’re not quite sure what to do. And I use clinical criteria as a way to try and decide about chemotherapy or not in that intermediate-risk group.

And we look, really with great excitement, for the data from the TAILORx trial. That will give us more information on that intermediate-risk group. At the same time, I think that both tests are very, very useful and that we do tend to use the 21-gene score a lot about decisions about chemotherapy for node-negative disease. And then we tend to use the 70-gene score a little bit more about decisions in terms of trial participation in the neoadjuvant setting and in differentiating difficult situations where patients have a lot of bulk of disease.

DR LOVE: What about node-positive disease? There’s been a lot of controversy about that. There’s a recent ASCO Guideline saying, “Don’t use it.” What’s your take on that?

DR RUGO: There’s the data from MINDACT that suggests that, if you take patients with very high clinical risk, maybe assess a little bit differently, that maybe there’s some benefit in chemotherapy. So maybe the ASCO Guidelines was erring on the side of too much caution by saying you shouldn’t use it and that you might not give chemo to somebody who would benefit. On the other hand, patients who have 1 to 3 positive nodes, who have a very indolent cancer, seem to benefit very little from chemotherapy. So I actually don’t agree with those ASCO Guidelines. And I think both the 21-gene Recurrence Score and the 70-gene test can be used to try and understand who has minimal node involvement, who might be able to be spared chemotherapy.

DR LOVE: I was talking with George Sledge about this and he was saying that he’s heard or he’s experienced people having problems getting reimbursement now in the node-positive situation because of this ASCO statement. Is that something you’ve had happen to you?

DR RUGO: We haven’t run into it quite yet. I can generally make a pretty good case for using the test. But I do know that this is an upcoming and ongoing, potentially increasing issue. And I think it would be a shame, because tumor biology is incredibly important. You can’t take it out of context of the clinical features, but it is incredibly important. So I think not allowing us to look at tumor biology in these patients would be an unfortunate decision.

Genomic assays and (neo)adjuvant treatment decision-making

Early-stage breast cancer in the adjuvant and neoadjuvant settings

Management of metastatic breast cancer (mBC)

CDK4/6 inhibitors for the treatment of breast cancer

Checkpoint inhibitors and other novel immunotherapeutic approaches to breast cancer

Triple-negative and BRCA mutation-positive breast cancers