Table 2.
Modified intention-to-treat population | D (n=23) | DC (n=23) | DS (n=23) |
---|---|---|---|
Best overall response, n (%) | |||
Complete response | 0 | 0 | 0 |
Partial response | |||
Confirmed partial response | 1 (4.3) | 1 (4.3) | 2 (8.7) |
Unconfirmed partial responsea) | 0 | 2 (8.7) | 1 (4.3) |
Stable disease | 6 (26.0) | 10 (43.5) | 9 (39.1) |
Progressive disease | 16 (69.6) | 9 (39.1) | 11 (47.8) |
Inevaluableb) | 0 | 1 (4.3) | 0 |
ORR (95% CI, %) | |||
Confirmed ORR | 4.3 (0-12.6) | 4.3 (0-12.6) | 8.7 (0-20.2) |
ORR including unconfirmed partial response | 4.3 (0-12.6) | 13.0 (0-32.9) | 13.0 (0-32.9) |
D, docetaxel; DC, docetaxel plus cisplatin; DS, docetaxel plus S-1; ORR, overall response rate; CI, confidence interval.
The tumor response was not confirmed by a second evaluation at least 4 weeks later following the first documentation of a response,
Computed tomography measurement was not available due to follow-up loss.