Breast Cancer Update for Surgeons, Issue 1, 2017 (Video Program)Second opinion: Surgical resection of an intact primary tumor in a 49-year-old woman with ER/PR-negative, HER2-positive metastatic BC after complete response of a solitary liver metastasis to paclitaxel/trastuzumab/pertuzumab
6:02 minutes.
TRANSCRIPTION:
DR KHAN: This is actually a question to which one cannot give a wrong answer today, in terms of the data available. So we have 2 randomized trials that have been reported. One of them has been published in The Lancet, and the other has not been published, but the 5-year results were reported at ASCO. That was conducted in Turkey. So the Tata Memorial trial showed no benefit for surgical resection of the intact primary tumor, and they generally followed with radiotherapy as well. So the combination of surgery and radiotherapy did not benefit women in the Indian study. In the Turkish study, the 2-, 3-year results that they reported at San Antonio, I think it was in 2013, they showed also no advantage to local treatment for the intact primary tumor. But the longer-term results, the 5-year results that they presented at ASCO this past summer, they did find an advantage and their hazard ratio, I believe, was 0.6 or something in that range. So those are discordant results between the 2 trials. The interesting thing is that the Indian trial, they actually did use systemic therapy first, as was received by this patient, I think very appropriately so. And despite the fact that the women who didn’t respond to systemic therapy were not randomized, so they had sort of a purified population of responders, they didn’t see any benefit. In the Turkish trial, there was no up-front systemic therapy, so everyone was randomized. And despite that, they saw a benefit. The problem with the Turkish trial that’s somewhat problematic anyway in terms of the interpretation is that the randomization was imbalanced. So the surgical group had a more favorable profiling in general. They had more women with smaller tumors, fewer women with visceral disease, more women with bone-only disease and so forth. So I think we have to wait and see what the published results tell us. But there is some concern about the conduct of the study at the level of the — at least the balance of the randomization. And they didn’t have any stratification factors, so it’s going to be very hard to get subtypes, specific information out of that population. And then the other indication I think for resection of the primary tumor, in my book at the moment, anyway, is the woman where the distant disease is well controlled on systemic therapy but the primary tumor is progressing. And that happens not very often. It happens in maybe a quarter or a third of patients. And when that happens, I’m happy to resect the primary tumor. But otherwise, I try to reassure the patient, and if necessary the medical oncologist, that the majority of these women, their primary tumor remains controlled on systemic therapy and doesn’t become a problem for them. DR LOVE: And I remember seeing a discussion you did on this, on one of those data sets you were just talking about, where you brought up I think the important point, that we're not talking about people who have local therapy control issues. You’re talking about, like this lady here is not being threatened by out-of-control local disease. And yet you’re saying maybe you would do surgery with the hope of extending her survival. What other data are we going to see on this question? I know there’s a — is it an ACOSOG trial looking at this? DR KHAN: It was actually an ECOG study. So the ECOG study, the US study closed last year, early last year, and we’re hoping for some results in 2017. That study was designed with systemic therapy first. The responders or stable disease are randomized to surgery plus radiation or no further local intervention unless they need palliation. And so those results hopefully we’ll see next year. The other study that’s also ongoing, which is a decent-sized study, is in Japan, again, designed similarly. So there’s systemic therapy up front. The responders are randomized. And they will probably close their accrual next year, so they won’t have results for a little bit longer. DR LOVE: And what about this doc’s question in terms of the type of surgery? From what I can tell, it sounds like it would be fairly easy to do breast conservation. Is that what you generally would do? And what about the axilla? DR KHAN: Absolutely. The axilla at the moment — so when we designed our trial we included axillary evaluation in the trial because the question that was asked in the trial was that if you apply the same local therapy to Stage IV patients as you do to non-Stage IV patients, is that going to benefit them? But until we get information on that, I actually don’t approach the axilla unless it’s clinically necessary. So if there’s a palpable node, I’ll excise the gross nodal disease. But if the axilla seems clinically free, I would not approach the axilla. |