Table 1.
Efficacy of oral trifluridine/tipiracil vs placebo in the phase III TAGS trial in patients with metastatic gastric cancer who had previously completed at least two chemotherapy regimens [16]
| Treatmenta (no. of ITT pts) | Median OSb | Median PFS | ORR | Disease controlc | Median time to deteriorationd | |||
|---|---|---|---|---|---|---|---|---|
| Months | HR (95% CI) | Months | HR (95% CI) | % of pts | % of pts | Months | HR (95% CI) | |
| FTD/TPI (337) | 5.7 | 0.69* (0.56–0.85) | 2.0 | 0.57** (0.47–0.70) | 4 | 44** | 4.3 | 0.69* (0.56–0.85) |
| Placebo (170) | 3.6 | 1.8 | 2 | 14 | 2.3 | |||
BSC best supportive care, CI confidence interval, ECOG Eastern Cooperative Oncology Group, FTD/TPI trifluridine/tipiracil, HR hazard ratio vs placebo, ITT intent to treat, ORR objective response rate, OS overall survival, PFS progression-free survival, pts patients
*p < 0.001, **p < 0.0001 vs placebo (two-sided p value)
aPatients received 35 mg/m2 FTD/TPI or placebo orally twice daily on days 1–5 and 8–12 of each 28-day cycle (in addition to BSC)
bPrimary endpoint
cProportion of pts with a complete response, a partial response or stable disease (tumour response was assessable in 290 pts in the FTD/TPI group and 145 pts in the placebo group)
dTime from randomisation to deterioration of ECOG performance status to 2 or greater