Yeah, nowadays we are using the ctDNA to monitor. It’s a way to monitor minimal residual disease. So some, as mentioned in this situation, it’s pretty clear in the perioperative space, right? So after surgery, everything has been resected. Patients may have or may not have high risk factors. And the question is, what needs to be given? Nowadays, if it’s more than T2, you can, more than T3, you can give nivolumab or pembrolizumab...
Yeah, nowadays we are using the ctDNA to monitor. It’s a way to monitor minimal residual disease. So some, as mentioned in this situation, it’s pretty clear in the perioperative space, right? So after surgery, everything has been resected. Patients may have or may not have high risk factors. And the question is, what needs to be given? Nowadays, if it’s more than T2, you can, more than T3, you can give nivolumab or pembrolizumab. What to do in patients with T2? What we’re doing nowadays is like check the ctDNA. And if the ctDNA is positive, then you can start giving immunotherapy. Also, the ctDNA is being implemented with the idea of bladder preservation. So, with the new explosion of results in the perioperative space, we saw here at ASCO the results of the EV304 using EVP, neoadjuvant, surgery, and adjuvant EVP. What’s happening is that patients are receiving four cycles of EBP before surgery. The rate of pathologic complete responses, so no tumor left behind, is really high. It’s 65%. So it’s amazingly high. And the question here is, in these patients that obtain the complete pathological response, do we need to give adjuvant therapy? And here’s when people start implementing the ctDNA and say, well, maybe if a patient has a complete pathological response and the ctDNA is negative, maybe we can save them from giving additional adjuvant therapy. But nowadays, we cannot do that. So those are assumptions. Maybe patients that are having toxicity are unable to receive adjuvant. In this patient, you could hold the treatment. But nowadays, what needs to be done is give neoadjuvant surgery and then adjuvant. And obviously, people are thinking that based on this high rate of pathological complete response, we are thinking about bladder preservation. So if you receive four cycles of EBP, you see that the ctDNA goes completely negative, imaging like an MRI or CT, everything is gone. Maybe these patients being monitored with ctDNA, we can preserve their bladder. So that’s the future. If we need to add radiation therapy or not, that’s a question. There are clinical trials nowadays that this is the aim, giving the strongest combination in the neoadjuvant setting that leads to this high rate of pathologic complete responses, and then try to preserve the bladder. Even giving additional treatment, given radiation therapy, but I think that’s the future. Still, we need more data because, as mentioned, in the IMvigor211, we saw that patients that, when checking the ctDNA being negative, the patients didn’t recur, but at one year, there is 12% of patients that still can recur having the ctDNA being negative. So it’s still, there needs to be an optimization of this test in order to capture the minimal residual disease. And in fact, Signatera, there is a platform that is, Signatera has two ways of interpreting, the positive or negative. So positive is if you have two or more variants detected in the blood, the test is positive. But then there is this other way that is looking for the concentration based on the levels of mtDNA per milliliter, so mtDNA stands for mean tumor molecules per milliliter, and that way maybe we can like score how much tumor is floating around. So this platform that is based on 16 genes, now there’s this, it’s being expanded, so it will be much more sensitive and much more specific. So yeah, the future is brilliant because we are improving in this sense of capturing the minimal residual disease.
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