Assisting Community-Based Oncologists and Surgeons in Making Neoadjuvant Treatment Decisions for Patients with Early Breast CancerATEMPT adjuvant study in HER2-positive disease
3:17 minutes.
TRANSCRIPTION:
DR BLACKWELL: The ATEMPT study builds on a single-arm study of paclitaxel plus trastuzumab for low-risk HER2-positive breast cancer. And “low risk” is a small tumor size, ER-negative. I think they can be up to 2 centimeters, or up to 3 centimeters if they’re ER-pos — something along those criteria, all clinically node-negative. Not a huge criteria to evaluate the axilla, but what you think is a node-negative, smaller, HER2-driven breast cancer. And these patients are randomized to either T-DM1 as a single agent or a taxane plus trastuzumab. The study is not powered to look at outcome. It’s actually been powered to look at tolerability of the 2 regimens. And so now that we have that study open — because you really couldn’t get T-DM1 covered outside of the setting of a clinical trial — for ER-positive or very small ER-negative, HER2-positive, because we have that trial available, if a patient can go to the OR and get the surgery they want in the OR, ie, my surgeon says to me, “I can do a lumpectomy. The breast is going to look great.” And the patient, we’re having a discussion, “I can either give you taxane/trastuzumab/pertuzumab up front if the tumor’s big enough, or taxane/trastuzumab or, since your surgeon has just told you that you can go ahead and get the surgery you want, then if we do that now, you have a 50% chance of having this newer drug known as T-DM1.” A lot of people, obviously because T-DM1 is so well-tolerated and has received favor in the advocacy community, are coming in saying, “Can I have this?” Right now, that’s really the only way that I would feel comfortable offering T-DM1 in the adjuvant setting. DR LOVE: And I guess we should also mention, Terry, that the other arm, the comparator arm, was recently reported looking at the so-called TP regimen, paclitaxel and trastuzumab, in these lower-risk patients. What have you observed in terms of how well that’s tolerated? DR MAMOUNAS: That’s a very well-tolerated regimen I think, particularly for elderly patients, the ones that you really are — the borderline, whether you’re going to give them chemotherapy. And you don’t want to give them the full-blast chemotherapy that we use in the adjuvant trials. It’s a very well-tolerated regimen and people do very well. And then the data suggest that they do very well overall in terms of survival and disease-free survival. DR LOVE: Any comments on your experience with the TP regimen? DR BLACKWELL: Yes. We participated in that study, so I have a number of patients. I just saw someone 2 days ago who’s like 5 years out. And she was 72. Now she’s 77. It does have some toxicity. I mean, I tend to not like to throw chemotherapy regimens into really good and really bad, but paclitaxel as an entity has a fair amount of neuropathy. So for the patients who I would give the TP regimen, as Terry alluded to, are typically older and have less aggressive tumors. They’re also the same patients who are at risk for taxane neuropathy. So it makes having a better option, such as T-DM1, a really good opportunity. I think that study’s going to accrue quite quickly. |