Table 4.
Patient Outcome, by Study Component
| Outcome | Estimate (% or 95% CI) |
|||
|---|---|---|---|---|
|
| ||||
| Phase I Cohort | Phase II Cohort | |||
|
|
|
|||
| Sorafenib + Bevacizumab |
Sorafenib + Bevacizumab |
Sorafenib | All Patients | |
| Best Objective Response | ||||
| Evaluablea | 16 | 4 | 2 | 6 |
| Not Evaluable | 1 | 0 | 1 | 1 |
| CR | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| PR | 2 (12.5%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| SD | 9 (56.3%) | 2 (50.0%) | 2 (100.0%) | 4 (66.7%) |
| PD | 5 (31.3%) | 0 (0.0%) | 0 (0.0%) | 2 (33.3%) |
| Confirmed CR/PR | 1 (6.3%) | 2 (50.0%) | 0 (0.0%) | 0 (0.0%) |
| Time to Progression | ||||
| Events | 14 | 4 | 2 | 6 |
| Medianb (95% CI) | 3.0 (1.7–7.2) | 2.1 (0.4–8.6) | 16.3 (11.4–16.3) | 8.6 (0.4–16.3) |
| % Progression-Free | ||||
| 2 mos | 69.7% (41.7–86.1) | 50.0% (5.8–84.5) | 100.0% | 71.4% (25.8–92.0) |
| 4 mos | 44.3% (20.2–66.1) | 25.0% (0.9–66.5) | 100.0% | 57.1% (17.2–83.7) |
| Survival | ||||
| Events | 16 | 4 | 1 | 5 |
| Medianb (95% CI) | 9.2 (3.7–11.9) | 10.4 (4.4–13.3) | NE (13.9-NE) | 13.3 (4.4-NE) |
| % Alive | ||||
| 6 mos | 64.7% (37.7–82.3) | 75.0% (12.8–96.1) | 100.0% | 85.7% (33.4–97.9) |
| 1 year | 23.5% (7.3–44.9) | 50.0% (5.8–84.5) | 100.0% | 71.4% (25.8–92.0) |
a
Number of patients having at least 1 post-baseline assessment
b
Kaplan-Meier methodology