VIDEO: Stopping enzalutamide has little effect on prostate cancer quality of life

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Hi, I'm Steve Freedland, a urologist at Cedars-Sinai Medical Center in Los Angeles, California, as well as the Durham VA Hospital in Durham, North Carolina. And I'm here today to talk to you about two recent presentations, the ASCO 2024 meeting in June in Chicago that talked about quality of life impacts from treatment in patients with high risk, non-metastatic biochemical recurrence. So to put these in context, one was from the EMBARK study, which was co-led by myself and Neil Shore. And the other was from the Presto study led by Doctors Aggarwal and Chen. So what we know is that patients with biochemical recurrence sur rising PSAs after failed surgery or radiation, are at increased risk of developing metastatic disease. And particularly on that PSA doubling time, the rate of PSA rise is less than nine months.

Those patients are extremely high risk developing metastatic disease, relatively dying of their cancers. We know from the primary results from EMBARK published in New England Journal of Medicine in October of 2023, as well as the Presto study recently published in JCO that intensified androgen deprivation therapy. So adding either Enzalutamide and EMBARK or Enzalutamide alone or adding Apalutamide to ADT and Presto improves outcomes. So EMBARK, we saw improved metastasis free survival from Enzalutamide with or without ADT. It's now led to FDA approvals and CCN guidelines, EMA approvals in Europe, EUA guidelines. And for Presto, it was a slightly different study and it was 52 weeks of therapy. And then he went off it and was looking at time to PSA progression was, it was a smaller study, but half the number of people and, but still the same concept, an intensified ADT delayed PSA progression. And so the question now that being discussed at ASCO is what is the quality of life impact of those treatments? So specifically we know the treatments are good.

Again, Enzalutamide is now FDA approved in the guidelines as being used. But what is the impact of that on the quality of life? So if we look at the EMBARK study first, so it was presented by myself. I had the honor of doing that again on behalf of Neil Shore, many other co-authors. And what we looked at with EMBARK is with EMBARK, again, slightly different than Presto in terms of you get nine months of therapy and then we stopped treatment. And so the question we asked is when patients went off treatment, we stopped it if they had a good PSA response, I should say, not everyone got that treatment suspension, but what was that treatment suspension impact on quality of life? And by and large, the short answer we saw is we looked at many different domains and we really saw no impact on quality of life, of stopping treatment. And on the one hand you could say, well this is kind of surprising.

You're on this therapy and you stop it and you don't get any improvements. It doesn't quite make sense. But if you actually look at the data and go back to the original presentation, there was the original New England Journal of Medicine paper in October, but we also published in New England Journal of Medicine evidence, the quality of life data also in October of 2023. And what you saw is with that initial treatment, we didn't see dramatic declines in quality of life. And so if you have a treatment that doesn't negatively impact your quality of life, when you stop that treatment, your quality of life's not gonna rebound, 'cause it just never went down in the first place. So it really just speaks to how well tolerated these medication as in EMBARK was Enzalutamide, again, both combination with ADT as well as Enzalutamide by itself.

Not to say there's not side effects, there are certainly side effects, particularly one of the common side effects we see with Enzalutamide and ADT in general is hot flashes, other hormonal related symptoms. And it was actually nice when we stopped the treatment. We saw within 12 weeks all three alms, ADT, Enzalutamide combination and Enzalutamide alone, dramatic improvements in the hormonal therapy symptoms, which you would expect. So those symptoms bounce back pretty quickly. But global quality of life doesn't bounce back because never bounced down to begin with. So, so that, that was the story from that.