Breast Cancer Update, Issue 2, 2016 (Video Program) - Video 10Perspective on the ASCO statement regarding the use of genomic assays for patients with node-positive disease
2:20 minutes.
TRANSCRIPTION:
DR SLEDGE: So this is a really important question and, I think, a really interesting one. Recently, of course, we’ve seen ASCO Guidelines that have basically suggested that we not use genomic assays. And I think the ASCO Guidelines in particular called out the 21-gene assay to look at lymph node-positive patients. I would say that that is a — with all due regard to my colleagues on that committee — is a somewhat controversial statement. And again, I think this is the basic tension between those who focus on biology and those who focus on anatomy. I find it personally highly unlikely that the biology of breast cancer changes hugely when one goes from lymph node-negative to 1 or 2 positive lymph nodes. So I’ve personally been quite comfortable — again, based largely on retrospective data, such as the SWOG-8814 data set, but also Mitch Dowsett’s data sets — to think that these gene assays probably work across the spectrum of breast cancer going from lymph node-negative to lymph node-positive. DR LOVE: I think also you’ve used the term “retrospective” a couple of times, particularly referring to the Oncotype data. And while it was retrospective, of course, it was this unique concept of taking prospective trial data and looking at it retrospectively. DR SLEDGE: Correct. Yes. DR LOVE: So I think that’s probably why people have bought into that kind of thinking. But the thing that I found strange about that ASCO — and being a former president of ASCO — I don’t know whether it was the intention or the understanding. I mean, when you look at the language of that thing, it says, “Don’t do it. It should not be done.” DR SLEDGE: Yes. DR LOVE: It doesn’t say — whatever, it’s a difficult decision, individual, nothing. Just “Don’t do it.” And I have heard from people that since that came out — I don't know if you’ve had this experience — I’ve heard people say it’s been difficult to get it paid for in node-positive. Is that the case? DR SLEDGE: Yes. I’ve specifically had patients have the insurance company reject a request for use of the 21-gene assay in the lymph node-positive population. I personally think that’s unfortunate. |