In addition to improving overall survival compared with placebo, enzalutamide significantly improves health-related quality of life (HRQoL), pain, and skeletal-related events in asymptomatic or minimally symptomatic, chemotherapy-naive men with metastatic castration-resistant prostate cancer (mCRPC), a recent study published online early in the journal The Lancet Oncology has shown.
In the double-blind, phase III PREVAIL trial, 1,717 men with mCRPC were randomly assigned 1:1 to receive enzalutamide 160mg/day or placebo.
Researchers assessed HRQoL, pain status, the incidence of skeletal-related events, and the time to first skeletal-related event.
Results showed significant treatment differences in change from baseline to week 61 with enzalutamide versus placebo for most FACT-P endpoints and EQ-5D questionnaires, suggesting the HRQoL was improved in patients who received enzalutamide compared with placebo.
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Researchers also found that progression of pain at its worst was less common in the enzalutamide group than in the placebo group at week 13, but not at week 25.
The study also showed that 32% and 37% of patients in the enzalutamide and placebo groups, respectively, experienced a skeletal-related event by data cutoff.
Median time to first skeletal-related events was 31.1 months (95% CI: 29.5-NR) in the enzalutamide group and 31.3 (95% CI: 23-9-NR) in the placebo group (HR = 0.72; 95% CI: 0.61-0.84; P < 0.0001).
- Loriot Y, Miller K, Sternberg CN, et al. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol. 2015. [Epub ahead of print]. doi: 10.1016/S1470-2045(15)70113-0.