Table 3.
Multivariable analysis for progression-free survival and overall survival, including early tumor shrinkage.
| Progression-free survival | Overall survival | |||
|---|---|---|---|---|
| Variable | Hazard ratio (95% CI) |
P-value | Hazard ratio (95% CI) |
P-value |
| Treatment | .12 | .07 | ||
| GC | 1 | 1 | ||
| GS | 0.82 (0.47-1.79) | 0.78 (0.59-1.02) | ||
| Sex | .40 | .35 | ||
| Male | 1 | 1 | ||
| Female | 0.89 (0.68-1.16) | 0.88 (0.67-1.15) | ||
| Age | .08 | .77 | ||
| <65 years | 1 | 1 | ||
| ≥65 years | 0.79 (0.61-1.03) | 0.96 (0.73-1.27) | ||
| ECOG PS | .49 | <.01 | ||
| 0 | 1 | 1 | ||
| 1 | 1.11 (0.82-1.51) | 1.54 (1.13-2.09) | ||
| Primary tumor site | .34 | .20 | ||
| Gall bladder | 1 | 1 | ||
| Non-gall bladder | 0.88 (0.67-1.15) | 0.84 (0.63-1.10) | ||
| Biliary drainage | .39 | .08 | ||
| Absent | 1 | 1 | ||
| Present | 1.13 (0.86-1.48) | 0.71 (0.48-1.04) | ||
| Prior surgical resection | .37 | .08 | ||
| Absent | 1 | 1 | ||
| Present | 0.85 (0.59-1.22) | 0.71 (0.48-1.04) | ||
| Diameter of measurable target lesions | .73 | .78 | ||
| <51 mm | 1 | 1 | ||
| ≥51 mm | 0.95 (0.71-1.27) | 0.96 (0.71-1.29) | ||
| CEA | <.01 | <.01 | ||
| <3.8 ng/mL | 1 | 1 | ||
| ≥3.8 ng/mL | 1.50 (1.15-1.97) | 1.72 (1.29-2.29) | ||
| CA19-9 | .03 | <.01 | ||
| <174.7 U/mL | 1 | 1 | ||
| ≥174.7 U/mL | 1.36 (1.03-1.78) | 1.65 (1.25-2.19) | ||
| ETS at 6 weeks | .01 | <.01 | ||
| <20% | 1 | 1 | ||
| ≥20% | 0.70 (0.52-0.93) | 0.60 (0.44-0.81) | ||
Abbreviations: CI: confidence interval; GC: gemcitabine plus cisplatin; GS: gemcitabine plus S-1; ECOG PS: Eastern Cooperative Oncology Group performance status; CEA: serum carcinoembryonic antigen; CA19-9: serum carbohydrate antigen 19-9; ETS: early tumor shrinkage.