Table 3.

PFS and probability of patients with PFS

ITTASCT-intentASCT-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 
ITTASCT-intentASCT-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.

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