Table 1.
Parameter | ALSYMPCA [3] | International EAP [9, 14] | ||
---|---|---|---|---|
Radium-223 n = 614 |
Placebo n = 307 |
HR (95% CI) | N = 696 | |
Median overall survival, months | 14.9 | 11.3 | 0.70* (0.58–0.83) |
16 (95% CI: 13–NE) |
Median time to first SSE, months | 15.6 | 9.8 | 0.66* (0.52–0.83) |
18 (95% CI: 17–NE) |
Median time to total ALP progression, months | 7.4 | 3.8 | 0.17* (0.13–0.22) |
8 (95% CI: NE–NE) |
Median time to PSA progression, months | 3.6 | 3.4 | 0.64* (0.54–0.77) |
4 (95% CI: 3–4) |
*p < 0.001
ALP, alkaline phosphatase; CI, confidence interval; EAP, early access programme; HR, hazard ratio; mCRPC, metastatic castration-resistant prostate cancer; NE, not estimated; PSA, prostate-specific antigen; SSE, symptomatic skeletal event