Table 1. Overall Survival and Progression-Free Survival Among Patients Who Had or Had Not Undergone Gastrectomya.
| End Point | Gastrectomy Subgroup | No Gastrectomy Subgroup | ||||
|---|---|---|---|---|---|---|
| Trifluridine/Tipiracil (n = 147) | Placebo (n = 74) | HR (95% CI) | Trifluridine/Tipiracil (n = 190) | Placebo (n = 96) | HR (95% CI) | |
| Overall survival, median (95% CI), mob | 6.0 (4.6-7.0) | 3.4 (2.7-3.8) | 0.57 (0.41-0.79) | 5.6 (4.6-6.2) | 3.8 (3.1-5.9) | 0.80 (0.60-1.06) |
| Rate (95% CI), % | ||||||
| 6 mo | 50 (41-58) | 24 (15-35) | NA | 44 (37-52) | 39 (30-49) | NA |
| 12 mo | 20 (12-28) | 9 (3-19) | NA | 22 (16-30) | 16 (8-26) | NA |
| Progression-free survival, median (95% CI), mob | 2.2 (1.9-3.0) | 1.8 (1.7-1.9) | 0.48 (0.35-0.65) | 1.9 (1.9-2.1) | 1.8 (1.7-1.9) | 0.65 (0.49-0.85) |
| Rate (95% CI), % | ||||||
| 4 mo | 24 (17-32) | 5 (1-12) | NA | 29 (22-36) | 10 (5-17) | NA |
| 6 mo | 13 (8-20) | 3 (1-10) | NA | 16 (10-22) | 9 (4-16) | NA |
Abbreviations: HR, hazard ratio; NA, not applicable.
a
Kaplan-Meier estimates in the intent-to-treat population.
b
95% CIs were calculated using the methods of Brookmeyer and Crowley.41