Dr. Andrea Apolo
speaker
97 appearances
1 recordings
1 series
first heard Oct 2024
last heard Oct 2024
Dr. Andrea Apolo’s voice in public audio — every appearance, attributed to the second.
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So great question. I wanted to also mention that we did look at PD-L1 status because in the nivolumab 274, checkmate 274 study, it was actually the patients that were PD-L1 high did better. And although here in the United States, it's approved for all patients, regardless of PD-L1 status, in Europe, it's really only approved for patients that are PD-L1 high, the adjuvant nivolumab.
So we did look at the marker in our study, in the ambassador study, and we found that it didn't matter if you were PD-L1 positive or negative, both groups had a benefit. So I think that's important because you're not worried that you're treating somebody that's PD-L1 negative and they're not going to have a benefit.
It was really strange actually that in the patients that were PD-L1 negative, they had the largest benefit, although there was a benefit in both groups. So regardless, the point is that we don't need PD-L1 status to select the patients for treatment for adjuvant pembrolizumab. And in terms of which one I would use, I was using nivolumab for a while.
And then while my trial was ongoing, I was using pembrolizumab. Then while we were waiting to date, I was using nivolumab. And now I've gone back to using pembrolizumab. And the reason I like pembrolizumab, I like them both, to be honest. They're both pretty easy to use. The nivolumab, the trial was done every two weeks. But I use them monthly because that's an FDA-approved dosing.
And for Ambassador, we did it every three weeks. But I use the six weeks. Every six, right?
So it's kind of nice in the adjuvant setting to let the patients have time off coming to clinic and seeing them every six weeks in terms of dosing because that's an FDA approved dosing schedule for pembrolizumab. So I think that's a plus that you can give it every six weeks.
I think there are more similarities and differences. And from the outcomes that we have seen, I don't really see any difference. So I use pembrolizumab. I like the dosing schedule, and I'm very comfortable with it.
So the upper tract data was not as robust as what we had seen in, you know, what we had hoped, but we had seen in lower tract patients, which are predominantly bladder, and it did include some urethra, but predominantly bladder. About 20% of the patients were upper tract, and we didn't limit the enrollment of upper tract.
And we actually didn't see a difference in terms of benefit with adjuvant pembrolizumab versus observation. And I can't explain why yet. We've done a bunch of subgroup analysis to try to tease out ureter versus renal pelvis. And the truth is these numbers are so small and the confidence intervals overlap. So it's really hard to make any conclusions from the data that we have.
It is a different biology, but I would have thought that these patients... maybe perhaps would have had a great response. And right now, I think we have a lot to learn and we need to tease that data a little bit more and really do trials in upper track to better understand who are the patients that benefit. Now, that being said, given that the trial was not really designed to
select for the upper tract patients and you can't make conclusions from subgroup analysis, I give it to upper tract patients. But I tell them the data. I tell them the data and I say, do you want it? And most patients want it because they... Upper tract is scary.
The question that I think comes up is what is the role now of adjuvant immunotherapy now that we have the Niagara data, right? So how does that fit in? I mean, if everyone's going to be getting Dervalium-AV plus Gem-Sys in the neoadjuvant setting,
And the truth is that that's not going to be the case because there's a lot of patients that, you know, refuse cisplatinum-based chemotherapy, are not eligible for cisplatinum-based chemotherapy, are not going to get any neoadjuvant chemotherapy. About, you know, half of our patients in the ambassador study got no neoadjuvant chemotherapy.
And, you know, the predominant reason was because they weren't eligible to receive it. And then there's also a group of patients that we think are not T2. And then we do the surgery and they are. And they are really high risk, higher than T2. So I think for those patients, adjuvant checkpoint inhibitor is still an important treatment option.
So I think that's where we'll kind of fit with the Niagara data that we just saw.
No, that's a great question. And right now what I'm doing is I do offer them cisplatinum-based chemotherapy if they did not receive it and they were eligible. But again, if they refuse it in the neoadjuvant setting, they're probably going to refuse it in the adjuvant setting.
They have their fear of the platinum-based chemotherapy, which we try to alleviate, but a lot of patients just don't want it. But I do offer it to patients if they didn't receive it and they're eligible in the adjuvant setting, I do offer them cisplatinum-based chemotherapy. And I also offer it for upper tract patients, which, you know, we have protective data for that.
It's such a great question. And I think there's a lot of effort right now ongoing to try to understand the role of biomarkers, specifically ctDNA, and how we can incorporate them prospectively and better select the patients that actually need therapy. So as medical oncologists, we intensify treatment a lot because we want to
provide the best overall outcomes for patients safely, of course, but give them the best chance. But we do over-treat patients. And I think that's why one of the reasons these adjuvant trials are so large is because we have to treat a lot of patients in order to see a benefit. And a lot of patients that we're treating, we're over-treating them, right? So not everybody needs it.
And then there's a small group of patients that may need even more that They may need intensification and just monotherapy, immunotherapy is not enough. So I think that's where the role of ctDNA comes in. And I love that there are prospective trials trying to answer that question right now, the Invigor 011.
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