Table 2.
Overall response rate and disease control rate by ICR and INV (tumor response evaluable population)
| ICR | INV | |||
|---|---|---|---|---|
| TAS-114/S-1 (n = 61) |
S-1 (n = 58) |
TAS-114/S-1 (n = 61) |
S-1 (n = 59) |
|
| Overall response rate, % (95% CI) |
19.7 (10.6–31.8) |
10.3 (4.0–21.5) |
19.7 (10.6–31.8) |
10.2 (3.9–21.2) |
| CR | 1 (1.6) | 0 | 0 | 0 |
| PR | 11 (18.0) | 6 (10.3) | 12 (19.7) | 6 (10.2) |
| SD | 37 (60.7) | 38 (65.5) | 36 (59.0) | 29 (49.2) |
| PD | 12 (19.7) | 13 (22.4) | 13 (21.3) | 23 (39.0) |
| Disease control rate (CR + PR + SD), % (95% CI) |
80.3 (68.2–89.4) |
75.9 (64.2–87.3) |
78.7 (66.3–88.1) |
59.3 (46.6–73.0) |
CI, confidence interval; CR, complete response; ICR, independent central review; INV, Investigator review; PR, partial response; PD, progressive disease; SD, stable disease