Table 2. Efficacy of Study Treatment.
| End point | Paclitaxel, cisplatin, and capecitabine (n = 118) | Cisplatin and fluorouracil (n = 120) | HR (95% CI)a |
|---|---|---|---|
| Failure-free survival | |||
| Recurrence or death events, No. (%) | 22 (18.6) | 41 (34.2) | |
| Rate at 3 y, % (95% CI) | 83.5 (77.0-90.6) | 68.9 (61.1-77.8) | 0.47 (0.28-0.79) |
| Distant metastasis–free survival | |||
| Distant metastasis, No. (%) | 12 (10.2) | 23 (19.2) | |
| Rate at 3 y, % (95% CI) | 91.4 (86.4-96.6) | 80.4 (73.6-87.9) | 0.49 (0.24-0.98) |
| Locoregional relapse–free survival | |||
| Locoregional relapse events, No. (%) | 8 (6.8) | 18 (15.0) | |
| Rate at 3 y, % (95% CI) | 93.8 (89.5-98.4) | 87.4 (81.4-93.8) | 0.40 (0.18-0.93) |
| Overall survival | |||
| Death events, No. (%) | 6 (5.1) | 13 (10.8) | |
| Rate at 3 y, % (95% CI) | 94.7 (90.6-98.9) | 88.9 (83.4-94.8) | 0.45 (0.17-1.18) |
| Response to induction chemotherapy, No. (%) | |||
| Overall response | 104 (88.1) | 96 (80.0) | NA |
| Complete response | 2 (1.7) | 4 (3.3) | NA |
| Partial response | 102 (86.4) | 92 (76.7) | NA |
| Stable disease | 14 (11.9) | 21 (17.5) | NA |
| Not evaluable | 0 | 3 (2.5) | NA |
| Response to the whole treatment | |||
| Overall response | 118 (100) | 115 (95.8) | NA |
| Complete response | 111 (94.1) | 102 (85.0) | NA |
| Partial response | 7 (5.9) | 13 (10.8) | NA |
| Stable disease | 0 | 1 (0.8) | NA |
| Not evaluable | 0 | 4 (3.3) | NA |
Abbreviations: HR, hazard ratio; NA, not applicable.
a
Calculated using the stratified Cox proportional hazards regression model.