Table 2. Summary of oncologic outcomes.
| Variable | PREVAIL (n=1,717) [6] | PREVAIL Korean (n=78) [10] | Current study (n=199) | ||
|---|---|---|---|---|---|
| ENZA (n=872) | Placebo (n=845) | ENZA (n=40) | Placebo (n=38) | ||
| Median time until chemotherapy (mo) | 28.0 | 10.8 | NYR | 11.2 | NYR |
| HR (95% CI) | 0.35 (0.30–0.40) | 0.21 (0.08–0.51) | |||
| Median time until PSA progression (mo) | 11.2 | 2.8 | 11.1 | 2.9 | 6.0 |
| HR (95% CI) | 0.17 (0.15–0.20) | 0.31 (0.17–0.56) | |||
| Median time until first SRE (mo) | 31.1 | 31.3 | NYR | 20.1 | NYR |
| HR (95% CI) | 0.72 (0.61–0.84) | 1.40 (0.46–4.33) | |||
| PSA decline of | |||||
| ≥50% from baseline (n/total n; %) | 666/854 (78.0) | 27/777 (3.5) | 28/40 (70.0) | 4/38 (10.5) | 139/187 (74.3) |
| ≥90% from baseline (n/total n; %) | 400/854 (46.8) | 9/777 (1.2) | Unknown | Unknown | 88/187 (47.1) |
ENZA, enzalutamide; HR, hazard ratio; CI, confidence interval; PSA, prostate-specific antigen; SRE, skeletal-related event; NYR, not yet reached.