Table 3.
PFS and probability of patients with PFS
| ITT | ASCT-intent | ASCT-no-intent | ||||
|---|---|---|---|---|---|---|
| Denosumab (n = 859) | Zoledronic acid (n = 859) | Denosumab (n = 465) | Zoledronic acid (n = 465) | Denosumab (n = 394) | Zoledronic acid (n = 394) | |
| Patients with a PFS event, n (%) | 219 (25.5) | 260 (30.3) | 91 (19.6) | 130 (28.0) | 128 (32.5) | 130 (33.0) |
| Median PFS (95% CI), mo | 46.1 (34.3-NE) | 35.4 (30.2-NE) | 46.1 (46.1-NE) | 35.7 (31.3-NE) | 30.4 (25.8-40.0) | 34.7 (25.1-NE) |
| HR* (95% CI) | 0.82 (0.68-0.99) | 0.65 (0.49-0.85) | 1.01 (0.79-1.30) | |||
| Descriptive P value | .036 | .002 | .92 | |||
| Probability of patients with PFS, %† | ||||||
| At month 6 | 92.3 | 90.3 | 95.8 | 91.9 | 88.1 | 88.3 |
| At month 12 | 83.6 | 81.5 | 89.6 | 84.9 | 76.5 | 77.5 |
| At month 18 | 76.5 | 72.1 | 82.7 | 75.4 | 69.1 | 68.3 |
| At month 24 | 69.2 | 63.7 | 77.7 | 68.0 | 58.9 | 58.5 |
| At month 30 | 60.6 | 55.1 | 68.9 | 58.5 | 50.5 | 51.4 |
| At month 36 | 54.7 | 48.7 | 63.6 | 49.9 | 42.8 | 48.1 |
| At month 42 | 51.4 | 44.2 | 61.2 | 44.6 | 38.0 | 44.4 |
NE, not estimable.
*
HR <1 favors denosumab.
†
Kaplan-Meier estimates.