Table 2.
OS and PFS in RECOURSE in elderly patients aged ≥65 years overall and by geographical subregion (ITT population).
| ITT | USA |
EU |
Japan |
Overall |
||||
|---|---|---|---|---|---|---|---|---|
| FTD/TPI (n = 27) | Placebo (n = 14) | FTD/TPI (n = 115) | Placebo (n = 61) | FTD/TPI (n = 86) | Placebo (n = 39) | FTD/TPI (n = 234) | Placebo (n = 118) | |
| Median OS, months | 7.8 | 4.0 | 6.3 | 4.4 | 7.8 | 6.8 | 7.0 | 4.6 |
| OS HR (95% CI) | 0.31 (0.13–0.79) | 0.59 (0.40–0.86) | 0.72 (0.47–1.09) | 0.62 (0.48–0.80) | ||||
| P value | 0.0099 | 0.0054 | 0.1143 | 0.0002 | ||||
| Median PFS, months | 3.9 | 1.6 | 2.1 | 1.8 | 2.0 | 1.8 | 2.1 | 1.8 |
| PFS HR (95% CI) | 0.24 (0.10–0.61) | 0.37 (0.26–0.53) | 0.52 (0.35–0.78) | 0.41 (0.32–0.52) | ||||
| P value | 0.0013 | <0.0001 | 0.0013 | <0.0001 | ||||
Abbreviations: CI, confidence interval; FTD/TPI, trifluridine/tipiracil; HR, hazard ratio; ITT, intention-to-treat; OS, overall survival; PFS,progression-free survival.