Table 1.
Univariate Cox-regression on overall survival
| Covariate | HR | Lower 95% CI | Upper 95% CI | P value |
| Treatment arm | ||||
| SBRT+nivolumab+ipilimumab | 1 | |||
| SBRT+nivolumab | 2.04 | 0.986 | 4.214 | 0.055 |
| Age, years | ||||
| >66.5 years | 1 | |||
| ≤66.5 years | 1.12 | 0.545 | 2.314 | 0.754 |
| Sex | ||||
| Female | 1 | |||
| Male | 0.608 | 0.287 | 1.287 | 0.193 |
| WHO performance status | ||||
| 0 | 1 | |||
| 1 | 1.297 | 0.620 | 2.715 | 0.49 |
| Weight loss >5% | ||||
| No | 1 | |||
| Yes | 1.437 | 0.693 | 2.977 | 0.33 |
| Number of metastatic sites | ||||
| ≥2 | 1 | |||
| <2 | 2.644 | 1.103 | 6.338 | 0.0292 |
| Whipple procedure | ||||
| No | 1 | |||
| Yes | 0.856 | 0.363 | 2.02 | 0.722 |
| Biliary stent | ||||
| No | 1 | |||
| Yes | 0.857 | 0.391 | 1.88 | 0.7 |
| Median CA19-9, kU/L | ||||
| ≤median | 1 | |||
| >median | 1.577 | 0.731 | 3.4 | 0.246 |
| NLR | ||||
| ≥5 | 1 | |||
| < 5 | 1.66 | 0.748 | 3.69 | 0.213 |
| Bilirubin, 25 µmol/L | ||||
| >25 | NA | NA | NA | NA |
| ≤25 | NA | NA | NA | NA |
| Albumin, 36 g/L | ||||
| ≤36 | 1 | |||
| >36 | 3.295 | 0.774 | 14.03 | 0.107 |
| CRP, 10 mg/L | ||||
| ≤10 | 1 | |||
| >10 | 0.920 | 0.445 | 1.902 | 0.823 |
| mGPS | ||||
| 0 | 1 | |||
| ≥1 | 0.920 | 0.445 | 1.902 | 0.823 |
| Prior lines of therapy | ||||
| <2 | 1 | |||
| ≥2 | 1.52 | 0.724 | 3.191 | 0.269 |
| Best optimal response to prior last therapy | ||||
| Clinical benefit | 1 | |||
| No benefit | 1.41 | 0.674 | 2.94 | 0.363 |
| ELISpot response to TGF-β-15 at baseline | ||||
| ≤median | 1 | |||
| >median | 0.171 | 0.066 | 0.44 | 0.000254 |
| Multivariate Cox-regression on overall survival | ||||
| Covariate | HR | Lower 95% CI | Upper 95% CI | P value |
| Number of metastatic sites | ||||
| ≥2 | 1 | |||
| <2 | 1.7 | 0.71 | 4.44 | 0.22 |
| ELISpot response to TGF-β-15 at baseline | ||||
| ≤median | 1 | |||
| >median | 0.18 | 0.071 | 0.5 | 0.0008 |
CRP, C-reactive protein; ELISpot, enzyme-linked immunospot assay; mGPS, modified Glasgow Prognostic Score; NLR, neutrophil-to-lymphocyte ratio; SBRT, stereotactic body radiotherapy; TGF-β, transforming growth factor-β.