Table 1.
Results from a phase 3, randomised, double-blind study comparing denosumab with zoledronic acid for the prevention of skeletal-related events in patients with bone metastases associated with breast cancer [19].
| Study arms | Zoledronic acid 4 mg i.v. Q4W | Denosumab 120 mg s.c. Q4W |
|---|---|---|
| Number of patients | 1020 | 1026 |
| Time to first SRE, months | 26.4 | NR |
| HR (95% CI) | 0.82 (0.71–0.95) | |
| p Value | <0.001 (non-inferiority) 0.01 (superiority) | |
| Time to first and subsequent SRE, RR (95% CI) | 0.77 (0.66–0.89) | |
| p Value | 0.001 (superiority) | |
p Values for superiority were adjusted for multiplicity; CI, confidence interval; HR, hazard ratio; i.v., intravenous; NR, not reached; Q4W, every 4 weeks; RR, rate ratio; s.c., subcutaneous; SRE, skeletal-related event.