Table 2.
Variables | BILCAP Trial (ITT) | BILCAP Trial (PP) | PRODIGE 12 Trial | BCAT Trial | ||||
---|---|---|---|---|---|---|---|---|
Treatment | CAP | Observation | CAP | Observation | GEMOX | Observation | GEM | Observation |
Median OS, months (95% CI) | 51.1 (34.6–59.1) | 36.4 (29.7–44.5) | 53 (40-not reached) | 36 (30–44) | 75.8 (34.4-not reached) | 50.8 (38.0-not reached) | 62.3 | 63.8 |
HR (95% CI) | 0.81 (0.63–1.04) | p = 0.097 | 0.75 (0.58–0.97) | p = 0.028 | 1.08 (0.70–1.66) | p = 0.74 | 1.01 (0.70–1.45) | p = 0.964 |
Median RFS, months (95% CI) | 24.4 (18.6–35.9) | 17.5 (12.0–23.8) | 25.9 (19.8–46.3) | 17.4 (12.0–23.7) | 30.4 (15.4–43.0) | 18.5 (12.6–38.2) | 36.0 | 39.9 |
HR (95% CI) | 0.75 (0.58–0.98) | p = 0.033 | 0.70 (0.54–0.92) | p = 0.0093 | 0.88 (0.62–1.25) | 0.48 | 0.93 (0.66–1.32) | p = 0.693 |
CAP = capecitabine, CI = confidence interval, GEM = gemcitabine, GEMOX = gemcitabine plus oxaliplatin, HR = hazard ratio, ITT = intention-to-treat, PP = per protocol, RFS = recurrence-free survival, OS = overall survival.