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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But that may be the way that we treat patients. We treat them systemically with therapy and hopefully not remove their bladder. So in a way that failure is actually a success for patients.
Yeah, no, I completely agree. We need to learn from those patients. Yeah.
Well, just that I think time will tell in terms of the rest of the outcomes of that trial and their other trials. Also, that we're awaiting their data that include platinum-based, cisplatinum-based chemotherapy in combination with with a checkpoint inhibitor, including the Energize study with nivolumab. And we also have the Keynote 866 study with pembrolizumab.
So there are additional trials that had this similar approach where they gave neoadjuvant cisplatinase-based chemotherapy with a checkpoint, and then there was an adjuvant component. So I think reading, I think the outcome of those trials will be super important. But for now, I mean, I think that we have to consider this a new standard of care. I mean, patients did so well.
They had an improvement in event-free survival, but they also had an improvement in overall survival. And that's so important for our patients because We've struggled to show an overall survival benefit in the perioperative setting. So we can be really critical about this trial, the way that they over-treated patients, but there was an overall survival benefit.
So I think, you know, we should consider including Dervalumab now in the neoadjuvant setting and in the adjuvant setting.
I think we're learning. I think that's a great concern to have. In this study so far, they did not report any issues with surgical outcomes or even post-surgical outcomes.
Yeah, and I think we need to understand that when the patients are getting combination therapy, the urologist and the medical oncologist need to stay really close in communications with labs because immune-related adverse events can occur at any time and often occur a little bit later. So could they occur postoperatively immediately? Of course they could.
So we don't have yet the details and the granularity of those kind of adverse events that occurred in this study, but I think that they will occur and it's important for the urologist and the medical oncologist to stay closely connected in this perioperative setting.
So patients with variant histology often are not included in trials. So I do love the fact that they did include patients with variant histology in this study. And I treat these patients as I would regular urothelial carcinoma, unless there's a small cell component in it or a neuroendocrine, a high-grade neuroendocrine component. Then I treat them as more like a lung component.
small cell cancer with that kind of paradigm in terms of the systemic therapies that I use. But in general, patients with variant histologies, I treat them as urothelial carcinoma until we have prospective data showing that another regimen or something different would be better for these patients.
Those are the patients that I get super nervous about because although they do respond well to platinum-based chemotherapy, they respond well to checkpoint inhibitors. They do have a higher rate of positive margins. They have a higher rate of recurrence. And I don't know how to better manage them with the therapies that we have right now without prospectively testing them.
But I feel like those patients... do need close surveillance and may benefit from more aggressive therapy, but I don't know what that more aggressive therapy is. I do think that they need systemic therapy. So I think going straight to surgery is not the answer.
I think they need more systemic therapy probably than other patients, but how to intensify that systemic therapy, I think we need to learn that. We don't know yet.
Yeah, sure. So the Ambassador Study, I was really excited to present the 45-month follow-up for the Ambassador Study. We had presented the 22-month follow-up at GU-ASCO, and we had a lot more data now. We're really fortunate to do a concurrent publication in the New England Journal of Medicine with the outcomes of the Ambassador Study.
So just to kind of summarize what it is, this is a phase three study randomized for patients with muscle invasive urethelial carcinoma who undergo radical surgery and they have high risk disease. And by high risk disease, This means they received neoadjuvant cisplatinibase chemotherapy and have a persistent T2 muscle invasive disease or greater.
And this includes positive margins and positive lymph nodes, which, you know, it's kind of special that we included positive margins. Or they did not receive cisplatinibase neoadjuvant therapy but have a T3 or greater muscle invasive disease or positive lymph nodes or positive margins.
So those patients were randomized and this trial was designed a while ago where there was really no treatment for these patients in the adjuvant setting, especially if they couldn't receive cisplatin and base chemotherapy, either neoadjuvant or adjuvant setting. The patients were randomized to receive pembrolizumab for one year versus observation.
with the dual primary endpoint of disease-free survival and overall survival. So we reported the outcomes of the disease-free survival and we found a doubling of the disease-free survival with adjuvant pembrolizumab. So it went from 14.2 months with observation to 29.6 months in the patients receiving pembrolizumab. So this was really exciting.
And the results just show that adjuvant pembrolizumab is effective in this setting and should be considered an option for patients that have high-risk muscle invasive disease.
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