Table 2.
The RECOURSE Trial: Trifluridine plus Tipiracil versus Placebo in Relapsed Metastatic Colorectal Cancer
| Efficacy measure | Trifluridine + tipiracil and best supportive care (N = 534) | Placebo and best supportive care (N = 266) |
|---|---|---|
| Overall survival | ||
| Deaths, N (%) | 364 (68) | 210 (79) |
| Median, mo | 7.1 (95% CI, 6.5–7.8) | 5.3 (95% CI, 4.6–6.0) |
| Hazard ratio | 0.68 (95% CI, 0.58–0.81) | |
| P <.001a | ||
| Progression-free survival | ||
| Events, N (%) | 472 (88) | 251 (94) |
| Median, mo | 2.0 (95% CI, 1.9–2.1) | 1.7 (95% CI, 1.7–1.8) |
| Hazard ratio | 0.47 (95% CI, 0.40–0.55) | |
| P <.001a | ||
a
Stratified log-rank test (strata: KRAS status, time since diagnosis of first metastasis, region).
CI indicates confidence interval.
Sources: Lonsurf (trifluridine and tipiracil) tablets prescribing information; September 2015; Mayer RJ, et al. N Engl J Med. 2015;372:1909–1919.