Several years ago, a small phase 2 study was begun. Tombal and colleagues have now reported updated results with at least 3 years of follow-up. At the time of enrollment, 39% of the men had metastatic disease. Overall, 54% of the men with metastatic disease developed a complete response. In the overall cohort, 57% have had at least an 80% drop in their prostate-specific antigen.
Importantly, the drug was well tolerated. A small number of men had problems with bone mineral density; changes in cholesterol, triglycerides, LDL, and HDL were very infrequent. Health-related quality-of-life results were also quite good. At 3 years, the results are very encouraging in this nonrandomized trial.
Of course, we need to have some caution, because the randomized trial that was done using Casodex® (bicalutamide) in this group of patients showed initial encouraging results but failed to show a survival benefit. Ultimately, the only way we will know whether this could be an alternative to castration is with a prospective randomized trial enrolling a significant number of patients.
Until that occurs, we can be encouraged that enzalutamide may play a role here and may be a good way to avoid many of the long-term side effects associated with castration. But we do need that randomized trial to know for sure whether it can be used in that role. Until then, we are encouraged. Hopefully, the forthcoming study will be done in a timely manner.
I look forward to your comments. Thank you.
Medscape Urology © 2018 WebMD, LLC
Any views expressed above are the author's own and do not necessarily reflect the views of WebMD or Medscape.
Cite this: Gerald Chodak. Enzalutamide 'Encouraging' in Hormone- Naive Prostate Cancer - Medscape - Feb 23, 2018.