So we presented two post-hoc analyses of the Phase III ARCHES trials. The ARCHES was the practice-changing landmark study in men with metastatic hormone-sensitive prostate cancer, now something we call androgen pathway modulator-sensitive disease. It established the survival benefit of enzalutamide in this population, delayed progression-free survival. But the first poster we looked at was trying to predict, using clinical features, treatment duration...
So we presented two post-hoc analyses of the Phase III ARCHES trials. The ARCHES was the practice-changing landmark study in men with metastatic hormone-sensitive prostate cancer, now something we call androgen pathway modulator-sensitive disease. It established the survival benefit of enzalutamide in this population, delayed progression-free survival. But the first poster we looked at was trying to predict, using clinical features, treatment duration. So treatment duration is somewhat of a surrogate of progression-free survival, but also of tolerability. So patients with short treatment durations of less than two years tended to have more issues with progression, but also tolerability, having treatment discontinuation due to toxicity. And conversely, the patients who are on enzalutamide for five plus years are obviously deriving substantial benefit in both delaying progression, but also exhibiting excellent tolerability. We found that the key factor that determined and predicted treatment duration was disease volume. However, we found that many patients with high disease volume that you might predict to be associated with short treatment duration still exhibited long treatment durations, really showing that even patients with synchronous high volume patients can derive five plus years of ARPI treatment benefit. I think the next stage is to really break apart the predictors into toxicity and efficacy so that we can identify the baseline characteristics of features that really may not tolerate the full dose of an ARPI that may require dose reductions or dose holds or strategies to maximize patient’s fitness, cardiovascular conditioning, so that they can tolerate this therapy long-term, which can improve survival and remissions. The second abstract focused on cardiovascular comorbidities, diabetes, hypertension, heart disease. As you know, most patients in their 60s and 70s who are facing metastatic prostate cancer and are treated with ARPIs also carry with them a lot of comorbidities. And so we looked at the ARCHES regimen in patients with zero or a few comorbidities, and we looked at it as a continuum, and we demonstrate the improved survival and delays in progression-free survival was really very similar, regardless of comorbidities. There were, you know, more toxicities that are experienced in patients with more comorbidities, which, again, illustrates the need for kind of proactive monitoring for bone health, fatigue, falls, fractures, conditioning, monitoring of blood pressure, which can be done in the community setting through home blood pressure monitoring, structured exercise programs, and bone density monitoring.
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