In clinical trials Enzalutamide (Xtandi) significantly increased the overall survival and radiographic progression-free survival of men when compared with placebo. The trial, called PREVAIL evaluated men who were asymptomatic and minimally symptomatic, chemotherapy-naive with metastatic castration-resistant prostate cancer.
The researchers expanded the data analysis and evaluated the effect of Xtandi on the men’s health-related quality of life (HRQoL), including pain, and skeletal-related events.
When they went back to the trial data they found that the median treatment duration of the men was 16.6 months in the Xtandi group and 4.6 months in the placebo group. Their analyses showed significant treatment differences in change from baseline to week 61 with men taking the Xtandi compared with placebo. Median time to deterioration was 11.3 months in the Xtandi group against 5.6 months in the placebo groups.
A significantly greater proportion of men in the Xtandi group than in the placebo group reported clinically meaningful improvements.
Median time to progression in pain at its worst was 5.7 months in the Xtandi group and 5.6 months in the placebo group.
The median time to first skeletal-related events in the Xtandi group was 31.1 months and 31.3 months in the placebo group.
In conclusion, in addition to improving overall survival relative to placebo, Xtandi significantly improves patient-related outcomes and delays occurrence of first skeletal-related event in chemotherapy-naive men with metastatic castration-resistant prostate cancer.
Lancet Oncol. 2015 May;16(5):509-21.
doi: 10.1016/S1470-2045(15)70113-0; Loriot Y, Miller K, Sternberg CN, Fizazi K, De Bono JS, Chowdhury S, Higano CS, Noonberg S, Holmstrom S, Mansbach H, Perabo FG, Phung D, Ivanescu C, Skaltsa K, Beer TM, Tombal,