Table 5.
Studies of antiresorptive drugs for the prevention of skeletal-related events in castration-resistant prostate cancer
Drugs studied | Study duration (months) |
Patients with skeletal- related events |
Median time to first skeletal-related event (months) |
Time to first and subsequent skeletal-related events |
|
---|---|---|---|---|---|
Saad et al (2004)5 | Zoledronic acid (n=214) vs placebo (n=208) | 24* | 81 (38%) vs 101 (49%); p=0·028 | 16·0 vs 10·5; p=0·009 | HR 0·64 (95% CI 0·485–0·845); p=0·002 |
Small et al (2003)19 | Pamidronic acid (n=169) vs placebo (n=181) | 6·8† | 42 (25%) vs 46 (25%); p value not reported | Not tested | Not tested |
Fizazi et al (2011) | Denosumab (n=950) vs zoledronic acid (n=951) | 41‡ | 341 (36%) vs 386 (41%) | 20·7 (95% CI 18·8–24·9) vs 17·1 (15·0–19·4); p=0·0002 (non-inferiority), p=0·008 (superiority)§ | RR 0·82 (95% CI 0·71–0·94); p=0·008§ |
n=number of patients. HR=hazard ratio. RR=rate ratio.
Fixed interval study with maximum of 24 months’ treatment duration.
Fixed interval study with maximum of 27 weeks’ treatment duration.
Event-driven study with maximum of 41 months’ treatment duration.
All randomised patients; p values were adjusted for multiplicity.