Personal Experience with Neratinib

Adam Brufsky, MD, PhD: Right now, I have a lot of experience with using this drug in the metastatic setting, as all of us do. I did not participate in ExteNET, so I don’t have any experience in the adjuvant setting. But I think the people that I will use this—again, it depends on the label, but I suspect it will be something like this—are women who have ER-positive, HER2-positive breast cancer, women who tend to have a lot of the disease left after neoadjuvant chemotherapy. Because the vast majority of people at high risk right now, at least in North America, usually get a trastuzumab-based, and potentially even a pertuzumab-based, regimen as neoadjuvant chemotherapy.

And so, again, with that regimen in the ER-positive subgroups, only about 30% to 40% of those women have a pathological response rate. So, there are 60% to 70% of women who don’t. And so, the real question is going to become, who of those women should be considering extended adjuvant therapy? And I think, at least for my practice, that’s likely going to be where I’m going to start using it.

Obviously, in that uncommon patient who surprises us all—the patient who has a small HER2-positive tumor taken out and has like 5 or 6 lymph nodes involved or 4 or more—I think those might be the people I’m going to initially use it in. And we’ll see where the data goes. If the data are really good, if it’s easier to use, we all get familiar with it, maybe we’ll do earlier stage patients. But I think a lot of us who are going to use it probably won’t use it up front. But those of us who are considering using it as extended adjuvant therapy I think are going to use it in those scenarios. Probably triple-positive, early stage breast cancer with a lot of disease after neoadjuvant chemotherapy is likely going to be the first group of people I use this in.