DR MILLER: We talk about it with the patient beforehand because for us, a key in ordering the Oncotype is that the patient and the oncologist agree that the Oncotype results will influence their treatment decisions. And in some patients, that could mean giving them chemotherapy that I didn’t think they were going to need, and in some cases it could mean not giving them therapy. But I would have a hard time giving this lady chemotherapy if she had a very low Oncotype score.
DR LOVE: Suppose she had three positive nodes. Would it be different?
DR MILLER: It would be a slightly different discussion with her, but no, it wouldn’t be different.
DR LOVE: How many nodes would it take to —
DR MILLER: So I’ve ordered it in somebody with four positive nodes who had a lot of risks for chemotherapy and we didn’t want to treat. I’ve ordered it in somebody with one positive node and a seven-centimeter tumor.
DR LOVE: Dan?
DR HAYES: Yes. So I wanted to actually challenge Kathy, although say the same thing she just said. And the reason I’m bringing all this up is, while I helped generate data to support this hypothesis — it goes all the way back to Marc Lippman in 1977 or ‘8 — and I fundamentally believe the biology suggests that so-called low Recurrence Score® or luminal A patients do have fundamentally chemotherapy-resistant cancers. We’re not sure of that. And that’s the whole point of the RxPONDER trial. And I really want to emphasize, I do not believe oncologists should start withholding chemotherapy from node-positive patients outside that trial. I believe that’s outside the standard of care. And if the standard of care outside that trial is chemotherapy for node-positive patients, unless there’s some reason not to give them chemotherapy...
DR MILLER: So when I said I do this regularly, I do, but you missed the part about the discussion with the patient, which includes all of the caveats you just said. And it’s with informed patients.
DR HAYES: So I don’t order this for a node-positive patient unless she’s on that study.
DR MILLER: And because those of us at IU feel differently, we are not participating in that study.
DR HAYES: And that’s where — then I don’t think you should be ordering it.
DR MILLER: Because I could not in good conscience give someone, who understands the issues and doesn’t want chemotherapy with a positive node or two and a very low score, chemotherapy.
DR LOVE: Hannah?
DR LINDEN: So I think a balanced discussion with a patient is imperative. Because we don’t want to get into the bind of ordering the test and then not having it influence what we’re going to do. If the patient, after hearing from me what the risks of recurrence are, is going to take the chemotherapy anyway, why order the test?
DR LOVE: Ian?
DR KROP: I do think that there’s enough circumstantial data from the retrospective studies that, after you do have a discussion with patients, that it’s very reasonable to offer the opportunity to do an Oncotype and if they have a low Oncotype score, withhold chemotherapy.
DR LOVE: Bill?
DR GRADISHAR: We fully support the RxPONDER trial, and we put patients on that study. Off of a study we view chemotherapy as a standard.
DR LOVE: Chuck?
DR VOGEL: We support the RxPONDER trial. And after a discussion with the patient, I would order an Oncotype off study.
DR LOVE: Terry?
DR MAMOUNAS: Only a couple of comments. I think I agree sort of with both sides of this discussion because I think there’re points that need to be taken here. First of all, I don’t think there is something dramatically different between node-negative and node-positive patients. Because you can argue that you may be uncomfortable not giving chemotherapy to a patient with one micromet in the sentinel node, but then you turn around and say, “I have a three-and-a-half-centimeter, node-negative patient. I do an Oncotype and it’s five and I feel comfortable not giving chemotherapy to that patient.” So there’s not much difference, as I think, in the biology or the outcome of these patients.
DR KROP: Dan, how do you feel about patients with node-negative disease with low Oncotype scores? We don’t have the TAILORx data yet.
DR HAYES: I order the Oncotype DX, the 21-gene Recurrence Score test, on every ER-positive, node-negative patient. And, in fact, I will say there are now data nationwide, both in the NCCN and in the Michigan Blue Cross/Blue Shield to show that we have decreased chemotherapy by 20 percent in node-negative, ER-positive patients. I’ll say it again: I’m proud of our field. I think we’ve done the right things to get rid of chemotherapy that’s not going to help enough people to make it worthwhile.