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Expert Discusses Safety Profile from the ENZAMET Trial

Christopher Sweeney, MBBS
Published Online:12:30 PM, Fri September 27, 2019


Christopher Sweeney, MBBS, professor of medicine, Harvard Medical School, and physician, Dana-Farber Cancer Institute, discusses the treatment-related adverse events (TRAEs) associated with adding enzalutamide (Xtandi) or non-steroidal anti-androgens to testosterone suppression treatment and docetaxel in patients with metastatic hormone-sensitive prostate cancer, as seen in the ENZAMET (ANZUP 1304) trial (NCT02446405).
 
Patients in the study were randomized 1:1 to receive either testosterone suppression plus enzalutamide or the non-steroidal anti-androgens, bicalutamide (Casodex), nilutamide (Nilandron), or flutamide (Eulexin). The phase III study results show that TRAEs occurred more frequently in the patients who received enzalutamide versus the non-steroidal anti-androgen, said Sweeney.
 
All TRAEs were between grades 1 and 3, with fatigue being the most common. Patients also experienced hypertension, syncope, seizures, and falls. Investigators noticed that adding enzalutamide to docetaxel also increased the rate of adverse events often seen with docetaxel alone. These AEs included neutropenic fever, sensory neuropathy, eye tearing, and nail discoloration. Sweeney says that it’s important to counsel patients about the possibility of increased docetaxel-related symptoms when adding enzalutamide to their treatment.
 
Overall, TRAEs in the first 30 days of the trial occurred in 42% of patients receiving docetaxel plus enzalutamide and in 34% of patients receiving docetaxel with a non-steroidal anti-androgen.
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