Enzalutamide appears effective in metastatic prostate cancer14 Jan 2016
Results from the Phase 2 TERRAIN trial of enzalutamide compared to bicalutamide in metastatic castration-resistant prostate cancer demonstrated the oncological efficacy of enzalutamide over bicalutamide.
The TERRAIN study achieved its primary endpoint demonstrating a statistically significant increase in progression-free survival for enzalutamide compared to bicalutamide. Lead author Dr. Neal D Shore and researchers reported that the analysis of the results revealed that:
- Median progression-free survival was 15.7 months in the enzalutamide group compared to 5.8 months in the bicalutamide group.
- The observed adverse event profile in TERRAIN appeared consistent with that from Phase 3 enzalutamide trials.
- ·The median time on treatment in TERRAIN was 11.7 months in the enzalutamide group versus 5.8 months in the bicalutamide group.
Adverse and cardiac effects of the treatments
The most common side effects occurring during treatment and more common in the enzalutamide-treated versus bicalutamide-treated patients included fatigue, back pain, hot flush, hypertension, diarrhea, weight decrease and pain in extremity.
Serious adverse events were reported in 31% of enzalutamide-treated patients and 23% of bicalutamide-treated patients. Individual Grade 3 or higher adverse events largely occurred at a similar rate between treatment groups, with the exception of hypertension (7.1% vs. 4.2%) and back pain (2.7% vs. 1.6%), which occurred more frequently in the enzalutamide treatment group.
Grade 3 or higher cardiac events were reported in 5% of enzalutamide-treated patients versus 2% of bicalutamide-treated patients. The majority of patients with these events in both treatment groups had cardiovascular risk factors at baseline. Two seizures were reported in the enzalutamide group and one in the bicalutamide group.
“Possible significant implications for clinical practice”
“These data show the promise of enzalutamide versus bicalutamide in metastatic castration-resistant prostate cancer,” said Professor Axel Heidenreich, M.D., Ph.D., Professor and Director, Department of Urology, University Hospital, Cologne, Germany.
“Enzalutamide was superior to bicalutamide in all primary and secondary endpoints demonstrating the drug’s oncological efficacy. Despite the fact that patients were treated with enzalutamide twice as long as with bicalutamide, no significant interference with quality of life was observed. These findings may have significant implications for the clinical practice.”Source: eCancer News