Comparison of the impact of degarelix and leuprolide on the health-related quality of life of patients with prostate cancer: Results of a 12-month phase III clinical trial
Introduction: The objective of this study was to compare health-related quality of life (HRQoL) with degarelix (240 mg in month 1 and then 80 mg monthly, administered subcutaneously) or leuprolide (7.5 mg/month intramuscularly) in men with prostate cancer.
Methods: HRQoL was assessed at baseline and throughout a 12-month randomized, open-label, parallel-group clinical trial using standard SF-12 and EORTC QLQ-C30 questionnaires. HRQoL outcomes were compared between treatments using trend, change score, and response analyses.
Results: HRQoL data from 401 subjects were included in this analysis; 205 receiving degarelix 240/80 mg and 196 receiving leuprolide 7.5 mg. Over the 12-month treatment period, patients experienced worsening of most HRQoL domains except for bodily pain, general health (both SF-12), and diarrhea (QLQ-C30). No treatment group differences in HRQoL were noted at day 28 or 6 months. At 12 months, mean SF-12 scores for the mental component summary (p = 0.02) and mental health (p = 0.04) were significantly higher in degarelix- compared with leuprolide-treated patients. Treatment with leuprolide had a seemingly more favorable impact on insomnia (QLQ-C30; p = 0.04) and bodily pain (SF-12; p = 0.006) compared with degarelix. Patients with metastatic disease treated with degarelix reported significant improvements in the role-emotional domain (SF-12; p = 0.02), global health status (QLQ-C30; p = 0.04), and appetite loss (QLQ-C30; p = 0.02) at 12 months compared with leuprolide.
Conclusions: After 12 months of treatment, the HRQoL of patients with advanced prostate cancer treated with the GnRH antagonist degarelix is similar to that of patients treated with leuprolide. The study also indicates benefits with degarelix treatment in the metastatic population.