Enzalutamide (Xtandi) has been proven effective in prolonging the overall survival of patients suffering from prostate cancer, while decreasing the probability of disease complications, when compared with watchful waiting, by the German Institute for Quality and Efficiency in Health Care (IQWiG). The study conducted in men older than 75 years revealed the added value of the drug.
The new research analyzed the drug, which was approved by the U.S. Food and Drug Administration (FDA), for the treatment of men with metastatic prostate cancer not susceptible to hormone-blocking therapy, mild symptoms or no symptoms at all, and not eligible for chemotherapy. Researchers from the German institute evaluated the drug’s properties and its added benefit when compared to the standard treatment for the condition.
The randomized controlled trial, entitled PREVAIL, revealed the benefits of enzalutamide both in older and younger patients. During the study, the participants were treated for 16.6 months with either enzalutamide or a placebo, as patients continued to receive the hormone-blocking treatment.
The study was used to confirm the results of the interim analysis, which demonstrated the efficacy and safety of enzalutamine. The data obtained revealed there is a statistical significance in overall survival associated with patients’ age. Moreover, the investigators concluded there are indications of added benefits from the drug therapy despite age.
In addition, the study demonstrated that bone-related complications are delayed as a consequence of enzalutamine treatment. Similarly, it delayed opiate use, which means it had a positive impact in severe pain. In terms of side effects, first-time hot flushes were the most reported, but researchers believe it had no influence in the overall benefits of the treatment.
Last January researchers from the Roswell Park Cancer Institute have also identified a novel approach to control aggressive and resistant forms of prostate cancer. The team, led by Leigh Ellis, PhD, was able to identify two genes, topoisomerase IIα, TOP2A (TOP2A), that mediate DNA structure and cell cycle progression, and the histone methyltransferase EZH2, that upon high expression levels in aggressive prostate tumors increases resistance to enzalutamide and abiraterone acetate therapies.