Advances in Urology: Focus on Prostate Cancer
Advances in Urology: Focus on Prostate Cancer
Enzalutamide is another hormonally based, FDA-approved therapy for mCRPC after docetaxel therapy; however, that also may soon change following the findings of the PREVAIL trial in which this drug was compared with placebo before chemotherapy. This study also was stopped prematurely because the group receiving enzalutamide had a 30% reduction in the risk for death (HR, 0.7). Median overall survival was projected to be 32.4 months for the study drug group compared with 30.2 months for men receiving placebo. An approval by the FDA will further complicate management because no studies have been reported that are aimed at determining how to sequence sipuleucel-t, abiraterone acetate, prednisone, and enzalutamide.
Another option became available this year for men with symptomatic metastatic disease to the bones when the FDA approved radium-223 on the basis of results of a phase 3 randomized trial. Patients with mCRPC entered the study if they either did not respond to docetaxel or were not good candidates to receive that treatment. At the interim analysis, median overall survival was significantly improved in men receiving the active treatment monthly for 6 months compared with those who took placebo (14.0 months for radium-223 vs 11.2 months for placebo; HR, 0.70; P = .002).
The benefit was confirmed following an updated analysis of the ALSYMPCA trial (median survival, 14.9 months vs 11.3 months; HR, 0.70; P < .001). Radium-223 also significantly prolonged the time to the first symptomatic skeletal-related event (median, 15.6 months vs 9.8 months; HR, 0.66; P < .001). Questions now arise as to the optimal timing of chemotherapy along with abiraterone, enzalutamide, and cabazitaxel.
Although prostate cancer remains the second most common cause of death from cancer in men, these new developments offer considerable hope for improved outcomes for men with this disease.
More Options Bring More Questions
Enzalutamide is another hormonally based, FDA-approved therapy for mCRPC after docetaxel therapy; however, that also may soon change following the findings of the PREVAIL trial in which this drug was compared with placebo before chemotherapy. This study also was stopped prematurely because the group receiving enzalutamide had a 30% reduction in the risk for death (HR, 0.7). Median overall survival was projected to be 32.4 months for the study drug group compared with 30.2 months for men receiving placebo. An approval by the FDA will further complicate management because no studies have been reported that are aimed at determining how to sequence sipuleucel-t, abiraterone acetate, prednisone, and enzalutamide.
Another option became available this year for men with symptomatic metastatic disease to the bones when the FDA approved radium-223 on the basis of results of a phase 3 randomized trial. Patients with mCRPC entered the study if they either did not respond to docetaxel or were not good candidates to receive that treatment. At the interim analysis, median overall survival was significantly improved in men receiving the active treatment monthly for 6 months compared with those who took placebo (14.0 months for radium-223 vs 11.2 months for placebo; HR, 0.70; P = .002).
The benefit was confirmed following an updated analysis of the ALSYMPCA trial (median survival, 14.9 months vs 11.3 months; HR, 0.70; P < .001). Radium-223 also significantly prolonged the time to the first symptomatic skeletal-related event (median, 15.6 months vs 9.8 months; HR, 0.66; P < .001). Questions now arise as to the optimal timing of chemotherapy along with abiraterone, enzalutamide, and cabazitaxel.
Although prostate cancer remains the second most common cause of death from cancer in men, these new developments offer considerable hope for improved outcomes for men with this disease.