Table 3.
Analysis of Objective Progression in the Bicalutamide EPC Program
| Time Taken for First10% | |||||
|---|---|---|---|---|---|
| of Patients to Progress (y) | |||||
| Risk Group | No. Patients | HR (95% CI) | ETR (95% CI) | Bicalutamide 150 mg/d | Placebo |
| Overall population | 4454 | 0.63 (0.50–0.80) | 1.41 (1.18–1.69) | 5.4 | 3.9 |
| Disease stage | |||||
| Localized disease | 2734 | 0.78 (0.54–1.13) | 1.21 (0.91–1.61) | 7.2 | 6.0 |
| Locally advanced disease | 1719 | 0.55 (0.40–0.75) | 1.56 (1.23–1.96) | 3.9 | 2.5 |
| Nodal status | |||||
| N0 | 3970 | 0.66 (0.51–0.85) | 1.36 (1.12–1.64) | 5.4 | 4.1 |
| Nx | 410 | –* | –* | –* | –* |
| N+ | 74 | –* | –* | –* | –* |
| Gleason score | |||||
| 2–4 | 456 | 1.11 (0.55–2.27) | 0.93 (0.56–1.56) | 3.8 | 4.2 |
| 5–6 | 2020 | 0.70(0.47–1.03) | 1.28 (0.98–1.66) | 5.8 | 4.6 |
| 7–10 | 1959 | 0.53 (0.38–0.74) | 1.68 (1.27–2.22) | 5.4 | 3.3 |
| Pretherapy PSA | |||||
| ≤ 4 ng/mL | 451 | –* | –* | –* | –* |
| > 4–10 ng/mL | 2229 | 0.69 (0.46–1.02) | 1.33 (0.98–1.82) | 7.2 | 5.4 |
| > 10 ng/mL | 1636 | 0.54 (0.39–0.75) | 1.56 (1.22–1.99) | 4.1 | 2.7 |
| Postprostatectomy PSA | |||||
| Nonquantifiable | 3792 | 0.63 (0.47–0.85) | 1.36 (1.12–1.66) | 6.2 | 4.6 |
| Quantifiable | 587 | 0.65 (0.42–1.00) | 1.50 (1.00–2.26) | 2.6 | 1.7 |
*
Too few events to calculate: hazard ratio (HR) and event time ratio (ETR)