Kathy D. Miller, MD; Hope Rugo, MD


December 20, 2013

In This Article

GeparSixto: Early Look at Platinum for TNBC

Dr. Miller: One of the earliest randomized studies was the GeparSixto study.[2,3] In its simplest version, it looked at adding platinums vs not adding platinums. At least in the triple-negative subset, we saw improvement in pathologic complete response (pCR) rates, but no one went home after hearing the GeparSixto study and started using [platinums in triple-negative disease].

Dr. Rugo: A few people did.

Dr. Miller: Maybe I'm just slow, but it just was tough for me to know what to do with that information

Dr. Rugo: I had previous experience of being impressed with platinums. That experience didn't change my practice, but when those data were presented, I thought 2 things: One was, what a shame that they used a nonstandard regimen, which is what you are saying.

Dr. Miller: That was part of the problem. It wasn't at all like a chemotherapy regimen that you would use, which made it hard to figure out how to take those data and incorporate them into my world.

Dr. Rugo: It fit my bias, so when I saw the data I thought, "These studies that we are waiting for are going to be positive," because it was so impressive and we have very few situations in which, even when combined with a nonstandard regimen, we see huge differences in the endpoint that don't play out somewhere. The Gepar group (the German Breast Group) is very good at doing these trials. They took patients who had either HER2-positive or TNBC and gave them a nonstandard regimen of myocet nonpegylated liposomal doxorubicin in a low dose, weekly, in combination with paclitaxel weekly. Everybody got bevacizumab because their previous trial had shown that bevacizumab was good in pCR. That is the nonstandard regimen that none of us are using.

The triple-negative and HER2-positive patients were analyzed separately with or without carboplatin. No difference was seen in the HER2-positive group, although we have seen data at this meeting that suggest that patients who benefit might have a lot of tumor-infiltrating lymphocytes (a separate story, still not proven).[4] In the group who had triple-negative disease there was a dramatic difference in pCR rate, and the Gepar group defines their pCR very rigorously and confirms it centrally. That made an impact on me, although it wasn't practice-changing.

Dr. Miller: We have 2 other studies this year, with chemotherapy regimens that I think will be more familiar, more comfortable -- if I can say that.

Dr. Rugo: Indeed.


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