Table 6.
Comparison of the Current Study With Single-Arm Combination Sorafenib-Interferon Alfa Studies and With Single-Agent Sorafenib
| Study | |||||
|---|---|---|---|---|---|
| Variable | Gollob 200727 | Ryan 200728 | Escudier 200929 | Current Combination | Current Sorafenib |
| No. of patients | 40 | 67 | 97 | 40 | 40 |
| Prior therapy, % | 37 | 0 | 0 | 0 | 0 |
| Risk stratification, % | |||||
| Low | 40 | 28 | 54 | 51 | 52.5 |
| Intermediate | 50 | 67 | 45 | 44 | 47.5 |
| Poor | 10 | 5 | 1 | 5 | 0 |
| Response data, % | |||||
| CR | 5 | 1 | 0 | 0 | 2.5 |
| PR | 28 | 18 | 5 | 25 | 27.5 |
| Unconfirmed PR | 11 | ||||
| SD | 45 | 39 | 74 | 50 | 42.5 |
| PD | 12 | 21 | 10 | 17.5 | 15 |
| Not assessable | 10 | 10 | 10 | 7.5 | 12.5 |
| Outcome, mo | |||||
| PFS | 10 | 7 | 7.6 | 7.4 | |
| Median survival | Not reached | 17 | Not available | Not reached | Not reached |
| Toxicity data | |||||
| No. of patients who required dose reductions (%) | 24 (65) | 51 (77) | 32 (33) | 24(60) | 16 (40) |
| No. of patients taken off study for toxicity (%) | 11 (28) | NA | 11 (11) | 7 (17.5) | 5 (12.5) |
CR indicates complete response; PR, partial response; SD, stable disease; PD, progressive disease; PFS, progression-free survival; NA, not available.