Table 1.
Median OS, PFS, and time to ECOG PS ≥2 in the PK/PD population of RECOURSE
| FTD |
TPI |
Overall PK/PD population |
||||||
|---|---|---|---|---|---|---|---|---|
| High FTD AUC (n = 69) |
Low FTD AUC (n = 69) |
Placebo (n = 72) |
High TPI AUC (n = 69) |
Low TPI AUC (n = 69) |
Placebo (n = 72) |
FTD/TPI (n = 138) |
Placebo (n = 72) |
|
| Median OS, months (95% CI) | 9.2 (7.6–10.7) | 7.2 (5.0–9.7) | 5.6 (4.0–7.3) | 7.8 (6.1–10.7) | 9.2 (7.2–10.2) | 5.6 (4.0–7.3) | 8.9 (7.2–9.9) | 5.6 (4.0–7.3) |
| Median PFS, months (95% CI) | 3.7 (2.1–3.9) | 2.0 (1.9–3.9) | 1.8 (1.6–1.8) | 2.0 (1.9–3.7) | 3.7 (2.1–4.3) | 1.8 (1.6–1.8) | 3.3 (1.9–3.8) | 1.8 (1.6–1.8) |
| Median time to ECOG PS ≥2, months (95% CI) | 7.8 (6.7–9.9) | 5.6 (4.4–9.5) | 6.3 (5.0–8.8) | 7.8 (6.1–9.6) | ||||
AUC, area under the curve; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; FTD, trifluridine; OS, overall survival; PD, pharmacodynamic; PFS, progression-free survival; PK, pharmacokinetic; TPI, tipiracil.