Table 1.
Efficacy results of the RESORCE phase III trial
| Outcome based on assessment per mRECIST | Regorafenib n = 379 (%) | Placebo n = 194 (%) | HR (95%CI) | P value |
| Response | ||||
| Complete | 2 (1) | 0 | - | NR |
| Partial | 38 (10) | 8 (4) | - | NR |
| Overall response rate | 40 (11) | 8 (4) | - | 0.0047 |
| Stable disease | 206 (54) | 62 (32) | - | NR |
| Disease control rate | 247 (65) | 70 (36) | - | < 0.0001 |
| Overall survival in mo | ||||
| Median | 10.6 | 7.8 | 0.63 | < 0.0001 |
| 95%CI | 9.1-12.1 | 6.3-8.8 | (0.50-0.79) | |
| Progression-free survival in mo | ||||
| Median | 3.1 | 1.5 | 0.46 | < 0.0001 |
| 95%CI | 2.8-4.2 | 1.4-1.6 | (0.37-0.56) | |
| Time to progression in mo | ||||
| Median | 3.2 | 1.5 | 0.44 | < 0.0001 |
| 95%CI | (2.9-4.2) | (1.4-1.6) | (0.36-0.55) | |
| Outcome based on assessment per RECIST 1.1 | ||||
| Response | ||||
| Complete | 0 | 0 | - | NR |
| Partial | 25 (7) | 5 (3) | - | NR |
| Overall response rate | 25 (7) | 5 (3) | - | 0.02 |
| Stable disease | 223 (59) | 62 (32) | - | NR |
| Disease control rate | 249 (66) | 67 (35) | - | < 0.0001 |
| Progression-free survival in mo | ||||
| Median | 3.4 | 1.5 | 0.43 | < 0.0001 |
| 95%CI | 2.9-4.2 | 1.4-1.5 | (0.35-0.52) | |
| Time to progression in mo | ||||
| Median | 3.9 | 1.5 | 0.41 | < 0.0001 |
| 95%CI | (2.9-4.2) | (1.4-1.6) | (0.34-0.51) |