Table 2.
Efficacy outcomes.
| OS | PFS | ORR | DCR | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| mOS (mos) | 95% CI | HR | p-Value | mPFS (mos) | 95% CI | HR | p-Value | PR + CR (%) | p-Value | PR + CR + SD (%) | p-Value | |
| T/R | 13.9 | 11.0–15.1 | 0.70 0.52–0.94 |
0.0194 | 8.8 | 8.2–33.8 | 0.61 0.46–0.80 |
0.0005 | 5.8 | 0.5177 | 34.1 | 0.5006 |
| R/T | 15.9 | 13.9–73.0 | 1.41 1.05–1.89 |
11.2 | 9.7–55.0 | 1.62 1.23–2.12 |
3.1 | 47.9 | ||||
| T | 6.3 | 5.6–7.4 | 1.10 0.92–1.32 |
0.2860 | 3.1 | 3.0–44.7 | 0.87 0.73–1.04 |
0.1435 | 2.5 | 1 | 23.3 | 0.6793 |
| R | 5.1 | 4.5–81.1 | 0.90 0.75–1.08 |
3.0 | 2.9–54.1 | 1.14 0.95–1.36 |
2.3 | 21.7 | ||||
Abbreviations: OS, overall survival; mOS, median overall survival; PFS, progression-free survival; mPFS, median progression-free survival; 95%CI, 95% confidence interval; HR, hazard ratio; T, trifluridine/tipiracil; R, regorafenib; PR, partial response; CR, complete response; SD, stable disease; ORR, overall response rate; DCR, disease control rate.