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Quality-of-life data from the trial showed greater initial declines in some areas with enzalutamide compared with physician's choice of bicalutamide, nilutamide, or flutamide, in men with recently diagnosed, metastatic hormone-sensitive prostate cancer, but there were overall benefits out to 3 years due to delayed disease progression, researchers reported.

In this exclusive 番茄社区app interview, , emeritus chair of the Glickman Urological and Kidney Institute and professor of surgery in the Lerner College of Medicine of the Cleveland Clinic, discusses his takeaways from the study.

The following is a transcript of his remarks:

In this paper, the authors extend their prior findings that demonstrated that the addition of enzalutamide to standard androgen deprivation in men with metastatic hormone-sensitive prostate cancer improved survival when compared to testosterone suppression and more standard nonsteroidal anti-androgens like bicalutamide, nilutamide, or flutamide.

In that study, the primary endpoint was overall survival. Those results were reported in the in 2019 and showed that men taking enzalutamide were about one third less likely to die at 36 months of follow-up, and that they also had significant improvement in the time to PSA [prostate-specific antigen] or clinical progression. And based on the results of that study, the FDA approved enzalutamide for frontline use in combination with the androgen deprivation in men with metastatic hormone-sensitive disease.

In the current report, the authors analyze patient-reported health-related quality-of-life outcomes in the ENZAMET trial, comparing the results in the two treatment arms. They made several important observations. The first was that enzalutamide was associated with worse mean ratings of fatigue, physical function, and cognitive function. But interestingly, and for reasons we'll see later, not in overall health and quality of life. These clinically significant declines occurred in just a minority of the patients. And in fact, most patients did not report much in the way of severe symptoms. The effects were mostly evident in the early treatment course and remain stable over time, meaning that they did not get worse with longer duration of treatment. Which is important because these agents tend to be used over a long period of time.

And interestingly, even though patients reported early declines in these three domains, at 3 years those taking enzalutamide actually had better overall quality of life because they were less likely to have progressive disease. Which meant that even though they were experiencing some fatigue and cognitive decline, they had fewer disease-related side effects such as pain, and they were less likely to require new treatments that have additive side effects.

So in summary, the ENZAMET trial established a new standard of care for men with metastatic hormone-sensitive prostate cancer. And the benefits of enzalutamide in delaying disease progression with respect to survival, disease-related symptoms, and delaying the need for additional therapy seem to outweigh modest early declines in some quality-of-life domains.

As a result of all of this it's clear enzalutamide is well tolerated and should be the standard of care in conjunction with androgen deprivation in men with metastatic hormone-sensitive prostate cancer.