Table 2 Summary of time-to-event end points: overall response and survival
GC ( N =41) | GEM ( N =42) | ||
|---|---|---|---|
n (%) | n (%) | P -value | |
Overall response rate | |||
Complete response (CR) | 0 (0.0) | 0 (0.0) | |
Partial response (PR) | 8 (19.5) | 5 (11.9) | |
Stable disease (SD) | 20 (48.8) | 16 (38.1) | |
Progressive disease (PD) | 9 (22.0) | 17 (40.5) | |
Not evaluable (NE) | 4 (9.8) | 4 (9.5) | |
Response rate (95% CI) | 19.5% (8.8, 34.9) | 11.9% (4.0, 25.6) | 0.380 |
Disease control rate (CR+PR+SD) (95% CI) | 68.3% (51.9, 81.9) | 50.0% (34.2, 65.8) | 0.119 |
Overall survival | |||
1-year survival rate (95% CI) | 39.0% (23.7, 54.4) | 31.0% (17.0, 44.9) | |
Median survival time (95% CI) | 11.2 months (9.1, 12.5) | 7.7 months (6.1, 11.0) | |
Hazard ratio (95% CI) | 0.69 (95% CI: 0.42, 1.13) | 0.139 | |
Progression-free survival (PFS) | |||
Median PFS (95% CI) | 5.8 months (4.1, 8.2) | 3.7 months (2.1, 5.3) | |
Hazard ratio (95% CI) | 0.66 (95%CI: 0.41, 1.05) | 0.077 | |
6-Months PFS rate (95% CI) | 47.4% (31.4, 63.4) | 27.7% (14.0, 41.5) | |
