Table 2. Efficacy results: objective response rate, progression-free and overall survival.
| Arm A: gemcitabine | Arm B: gemcitabine+200 mg WX-671 | Arm C: gemcitabine+400 mg WX-671 | |
|---|---|---|---|
|
Objective response by RECIST (n=85) | |||
| n | 26 | 28 | 31 |
| Partial remission | 3.8% | 7.1% | 12.9% |
| Stable disease | 84.6% | 75.0% | 77.4% |
| Progressive disease |
11.6% |
17.9% |
9.7% |
|
Progression-free survival (n=85) | |||
| n | 26 | 28 | 31 |
| Median PFS (months) | 8.2 | 5.6 | 8.3 |
| 95% confidence interval | 5.6–11.2 | 4.1–7.6 | 6.5–11.3 |
| 1 year PFS rate (%) |
16.2 |
22.5 |
26.9 |
|
Overall survival (n=95) | |||
| n | 31 | 31 | 33 |
| Median OS (months) | 9.9 | 9.7 | 12.5 |
| 95% confidence interval | 7.4–12.1 | 8.4–17.1 | 8.2–18.2 |
| 1 year OS rate (%) | 33.9 | 40.7 | 50.6 |
Abbreviations: OS=overall survival; PFS=progression-free survival.