Table 2. Overall survival and progression-free survival by gender and treatment arm.
| FOLFIRINOX arm (N = 171) | |||
| Male (n = 106) | Female (n = 65) | ||
| Deaths | 81 (76.4) | 45 (69.2) | |
| OS | |||
| Median OS, months (95%CI) | 10.3 (8.4–12.6) | 13.1 (9.0–13.7) | |
| 1-year OS, % (95%CI) | 42.8% (32.3–52.8) | 57.2% (43.30–68.9) | |
| HR (95%CI) | 0.73 (0.51–1.06) | ||
| p-value1 | 0.101 | ||
| PFS | |||
| Median PFS, months (95%CI) | 5.9 (4.2–7.1) | 7.2 (5.7–8.6) | |
| HR (95%CI) | 0.79 (0.57–1.10) | ||
| p-value | 0.169 | ||
| Gemcitabine arm (N = 171) | |||
| Male (n = 105) | Female (n = 66) | ||
| Deaths | 92 (87.6) | 55 (83.3) | |
| OS | |||
| Median OS, months (95%CI) | 6.4 (5.4–7.2) | 7.6 (5.3–9.4) | |
| 1-year OS, % (95%CI) | 19.7% (12.2–28.5) | 22.0% (12.3–33.5) | |
| HR (95%CI) | 0.80 (0.57–1.11) | ||
| p-value | 0.182 | ||
| PFS | |||
| Median PFS, months (95%CI) | 2.96 (2.04–3.65) | 3.48 (1.91–4.11) | |
| HR (95%CI) | 0.98 (0.71–1.34) | ||
| p-value | 0.876 | ||
| ITT trial population (N = 342) | |||
| Male (n = 211) | Female (n = 131) | ||
| Deaths | 173 (82.0) | 100 (76.3) | |
| OS | |||
| Median OS, months (95%CI) | 7.7 (6.8–9.0) | 9.4 (8.0–11.3) | |
| 1-year OS, % (95%CI) | 31.1% (24.5–38.0) | 39.1% (30.1–48.0) | |
| HR (95%CI) | 0.79 (0.62–1.02) | ||
| p-value | 0.068 | ||
| PFS | |||
| Median PFS, months (95%CI) | 3.9 (3.5–4.9) | 4.3 (3.6–5.7) | |
| HR (95%CI) | 0.87 (0.69–1.10) | ||
| p-value | 0.245 | ||
1 p-value corresponds to HR