Breast Cancer Update, Issue 2, 2016 (Video Program) - Video 3Role of pertuzumab in early-stage, HER2-positive BC
3:42 minutes.
TRANSCRIPTION:
DR SLEDGE: In the old days, I probably would have sat down with the patient and told the patient, indeed as I still do now, that adjuvant therapy and neoadjuvant therapy give one the same benefit in terms of long-term survival and, therefore, it was reasonable to consider either a mastectomy or to receive preoperative therapy to shrink the tumor and increase her likelihood of being able to have a lumpectomy. Today I would do it differently. And that is to say that, because we have an FDA approval for pertuzumab in the neoadjuvant setting but currently lack an FDA approval in the adjuvant setting, I would be likely to give this patient combined HER2-targeted therapy with trastuzumab and pertuzumab along with taxane-based chemotherapy and, of course, followed up with the trastuzumab out to a total of a year, as well as adjuvant hormonal therapy. I think physicians are in somewhat of a quandary — and again, some of this relates to insurance coverage issues; some of it relates to we don’t have the data in the adjuvant setting for pertuzumab — as to whether or not we should routinely be using pertuzumab in such patients. One, of course, sees differences from a guideline standpoint. The NCCN committee looking at this data has said that it’s reasonable to give adjuvant as well as neoadjuvant pertuzumab based on no data, based upon the opinion of the people in the room. We, of course, will have data hopefully in the not-too-distant future. But at present, certainly some insurers cover this and some do not. DR LOVE: I’d say maybe there’s no data, but there is some evidence or some rationale for what they’re proposing. We know there’s a huge split, maybe 50-50, among investigators about what they do and what they think about it. DR SLEDGE: Yes. There’s certainly a rationale. And the rationale is, of course, based upon data such as the NeoSphere data that says that there’s a huge pickup — I mean, a fairly dramatic pickup, also seen in the TRYPHAENA data set — in terms of pathologic complete response rates. We have, in the metastatic setting, as a result of the CLEOPATRA data, evidence for a significant survival advantage in the metastatic setting. And, therefore, it’s reasonable to think that that would translate into both the neoadjuvant and adjuvant settings for an improvement in survival for a HER2-positive patient. Now, “reasonable to think” is not the same thing as “we have data.” And it’s interesting, because I can’t think of any other drug in breast cancer where we have started routinely using it in the adjuvant setting without at least disease-free survival data. But we’re now doing that, of course, with pertuzumab in the neoadjuvant setting. DR SLEDGE: If you ask me at the end of the day where I think we’ll be in 2 or 3 or 4 years once the data is in, my bias — and it’s just a bias — is that combined HER2-targeted therapy is likely to end up being the standard of care. But we’re not there yet, so I can’t claim to be particularly dogmatic about this. But it is something I encourage for my patients. |