Table 2.
Best Tumor Response per RECIST
| Arm A AMG 386, 10 mg/kg qw + Sorafenib (n = 50) | Arm B AMG 386, 3 mg/kg qw + Sorafenib (n = 51) | Arm C Placebo + Sorafenib (n = 51) | |
|---|---|---|---|
| Objective response, % | |||
| Complete response | 0 | 2 | 2 |
| Partial response | 38 | 35 | 24 |
| Stable disease | 48 | 45 | 59 |
| Progressive disease | 8 | 10 | 10 |
| Unevaluablea | 0 | 0 | 2 |
| Not done | 6 | 8 | 4 |
| Objective response rate, % (95% CI) | 38 (25–53) | 37 (24–52) | 25 (14–40) |
| Comparison with placebo, (95% CI) | (−6.9 to 30.8) | (−7.5 to 30.0) | |
| Duration of response, mo (95% CI)b | 8.9 (7.4-NE) | 7.4 (5.9-NE) | 9.4 (5.5-NE) |
Abbreviations: CI, confidence interval; NE, not estimable; RECIST, Response Evaluation Criteria in Solid Tumors.
a
Includes patients with a response assessment of complete response, partial response, or stable disease before the scheduled first assessment of response without an additional response assessment.
b
Time from the first confirmed objective response to disease progression/death.