Table 1.
Comparison of denosumab vs. zoledronic acid in metastatic breast cancer (n = 2046).
| Endpoint | HR | 95% CI | p value |
|---|---|---|---|
| Primary endpoint | |||
| Time to first on-study SRE (noninferiority) | 0.82 | 0.71-0.95 | >0.0001 |
| Secondary endpoints | |||
| Time to first on-study SRE (superiority) | 0.82 | 0.71-0.95 | 0.01 |
| Time to first and subsequent on-study SRE | 0.77 | 0.66-0.89 | 0.001 |
| Exploratory endpoints | |||
| Overall disease progression | 1.00 | 0.89-1.11 | NS |
| Overall survival | 0.95 | 0.81-1.11 | NS |
| Skeletal morbidity rate (mean) (number of SREs per year) | D: 0.45; ZA: 0.58 | 0.004 |
CI, confidence interval; D, denosumab; HR, hazard ratio; NS, not significant; SRE, skeletal-related event (i.e. pathologic fracture, irradiation to bone, surgery to bone, spinal cord compression); ZA, zoledronic acid.