Cases from the Community: Investigators Provide Their Perspectives on the Practice Implications of Emerging Clinical Research — A Special Video SupplementCase discussion: A 65-year-old woman with ER-positive, HER2-negative, node-positive BC receives neoadjuvant palbociclib/letrozole on a clinical trial
4:05 minutes.
TRANSCRIPTION:
DR LOVE: 65-year-old woman with a 3.5-cm, ER-positive, HER2-negative, node-positive breast cancer who’s getting neoadjuvant letrozole/palbo on an NSABP trial, which I didn’t even know there was a neoadjuvant trial looking at these agents. So here are the questions that she has: So this patient is having a very good clinical response to this neoadjuvant treatment. So she wants to know in patients like this, if they have a path CR in the lymph nodes, what do you do with the axilla? The same question we were just talking about with neoadjuvant chemo. This patient looks like she’s having a clinical CR. If it’s actually a path CR and the sentinel node is negative, can you just leave it alone? DR O’SHAUGHNESSY: Yes. I think that that’s increasingly how surgeons are headed, Neil. And I’m very comfortable with that. If somebody has had a clinical and imaging magnificent response, no matter how you got there, actually, I think it’s reasonable to do a sentinel lymph node even though they were clinically positive to start off with. And if the sentinel lymph node is negative — and it’s always nice to see more than one, if possible, because there is some fibrotic reaction in the axilla. And there are some data that, after preoperative therapy, that the sensitivity of sentinel lymph node biopsy may not be quite as high as it is in the adjuvant setting or before any kind of preoperative therapy. So it’s nice to see several lymph nodes, sentinels, if possible. We know from really good data from NSABP-B-32 that the higher the number of negative sentinel lymph nodes, the higher that is a real finding. And then the issue is, what about postmastectomy radiation therapy? It’s easier, if she’s just going to have a lumpectomy. It’s easier to just include regional lymphatics. But if she’s having expanders placed after mastectomy, what do you do then? And in the ER-positive, I think it’s trickier. And I think that if I really felt that a woman had a low risk for local-regional recurrence because of a path CR and strongly ER-positive and she was going to definitely benefit from or have a high chance of benefiting from endocrine therapy, I would be comfortable not doing postmastectomy radiation therapy if looked up front, like she had, like, 1 positive node — of course different if you had multiple nodes positive on your scans up front. But no, I think we can work with that data. One issue I’ll raise, Neil, on that case is that we did a clinical trial similar to that with preoperative aromatase inhibitor with or without the PI3 kinase inhibitor BYL719, which is alpelisib. And we’re getting some really nice responses there. And most patients are still going to have residual disease when they go to surgery. But what if they’ve had a fabulous response and there isn’t much cancer left, and what’s left is strongly ER/PR-positive and very low Ki-67 and HER2-positive? Does that woman still need chemotherapy if she’s had that kind of a response? Whereas you might have given it to her up front just based on whatever, a bunch of nodes positive or what have you, we don’t know the answer to that, Neil. There’s a really nice trial going on, the ALTERNATE trial is going on to answer that question. So we don’t have it. So what I did, from a practical standpoint, I didn’t go with chemotherapy. If a woman had a beautiful response and the residual disease was luminal A and not very much of it, I said, “Hey, I just can’t see where you’re going to benefit from chemotherapy.” So I didn’t give it. So that’s kind of a good problem to have, but that’s going to happen more and more as we bring the CDK4/6 inhibitors and the PI3 kinase inhibitors into more preoperative studies. DR LOVE: And you actually addressed the other question this doc had about exactly what you were just saying, chemotherapy postop. |