Anthony Lucci, MD, University of Texas, MD Anderson Cancer Center, highlights the results of a study evaluating the role of modified radical mastectomy (MRM) in patients with de novo stage IV inflammatory breast cancer.

Transcript

Hi. I am Dr. Anthony Lucci, Professor of Surgery at The University of Texas MD Anderson Cancer Center. Today, we wanted to talk a little bit about the study which we have published recently, and it regards the utility of removal of the primary tumor or modified radical mastectomy in patients with de novo stage IV metastatic inflammatory breast cancer.

The reason this is an important study is that the data for the use of mastectomy in patients with stage IV or distantly metastatic disease has been unclear.

Editor’s Note: Another reason that the study is important, is that in inflammatory breast cancer, local control issues can severely decrease quality of life for breast cancer survivors. The chest wall wounds are often open, draining, and difficult to manage. So removing the primary tumor in stage IV patients might also help with improving quality of life for the patient with inflammatory breast cancer. 

Up until recently, there were several conflicting studies.

To give a background, in the ASCO Meeting last year, Dr Seema Khan and her associates presented data from the ECOG study showing that in patients who had de novo stage IV metastatic breast cancer, that patients who had mastectomy versus those who simply were treated with medical therapy, there was no significant difference in the overall survival outcomes.

One of the caveats to that study, however, is that inflammatory breast cancer patients were not included in that study for the most part. We chose to look at a contemporary group of inflammatory breast cancer patients seeing at the MD Anderson Cancer Center, and we wanted to look at a more contemporary group of patients where we could include those patients who completed trimodal therapy.

That would include patients who were able to complete systemic chemotherapy in a neoadjuvant or primary fashion, then had modified radical mastectomy, and then had inflammatory breast cancer-specific radiation therapy post-mastectomy.

When we looked at this group of patients that were able to complete trimodal therapy, what we found is that the patients that underwent mastectomy or removal of the primary tumor did significantly better than those patients who did not undergo surgical therapy with outcomes or median survival for the mastectomy group of somewhere around almost 60 months and for the non-operative group somewhere around 18 months.

That is a huge statistically significant difference. Of course, the question everyone has is, is this selection bias? Are you choosing the most favorable patients for surgery, in other words, those with the fewest metastatic site, those who are the best functional status, those with favorable tumor markers? Are you choosing the patients that are going to do the best? That is why you see these outcomes.

In this study, we try to account for that by trying to control for the number of metastatic sites to control for patients who responded to therapy versus those that had progression while on therapy and even when we controlled for those factors in the multivariate analysis, having removal of the primary tumor, converting a significant survival advantage for patients with inflammatory breast cancer.

Now, we have to also remember this is retrospective data. It is not a prospective randomized study, but it is very difficult to do prospective randomized studies for such a rare disease that only comprises 2-3% of all breast cancers. It's very difficult. I am not sure that we will ever have a prospective randomized study for inflammatory breast cancer.

The best available data that we have to date is to look at these patients in a retrospective fashion, and we see significantly better overall survival outcomes in this group of patients. I would also add that we looked at a similar group of patients in an older cohort years ago, and we found the same findings.

Even when we try to account for or remove the selection bias by taking, let's say, patients who progress on therapy with a limited number of sites, we still saw better outcomes in the patients that received removal of the primary tumor in the inflammatory situation with metastatic disease.

There could be a number of reasons for this. It could be that there is immune suppression of the host immune system by having this inflammatory mass present which is often the case with inflammatory patients. By removing that, you improve the immune response. We do not know.

We are looking at that question trying to answer that now in a prospective fashion, or maybe there's constant feeding of micro-metastatic disease with the primary tumor left in place. All of these are possibilities as to why it may be a different outcome for inflammatory patients versus non-inflammatory.

I would also add that there is some other conflicting data. A recent study that was just published this year from Turkey showed that patients who underwent mastectomy seem to also do better in the long-term outcomes than those that did not. That was in, again, stage IV de novo metastatic disease.

We have a situation where we do not have a lot of prospective data other than the single ECOG study which was presented at ASCO earlier this year. That is why this is an important study and why we obviously need to have some more prospective randomized studies in the future.

Currently, we offer our patient mastectomy in the stage IV metastatic inflammatory situation as long as they have had a positive response to therapy and we feel we could get negative margins. That is our current practice. I hope all this information would be helpful. Thank you.