Table 4. Cox proportional hazard regression analysis of the effect of immune-related adverse events development on progression-free survival and overall survival.
| Survival | Univariate analysis | Multivariate analysisb | ||||
| HR | 95% CI | P | HR | 95% CI | P | |
| PFS | ||||||
| Any irAEs | 0.509 | 0.305-0.849 | 0.01a | 0.521 | 0.309-0.877 | 0.014a |
| Skin irAEs | 0.298 | 0.174-0.510 | <0.001a | 0.297 | 0.172-0.513 | <0.001a |
| Endocrine irAEs | 0.232 | 0.073-0.742 | 0.014a | 0.269 | 0.083-0.874 | 0.029a |
| Hepatobiliary irAEs | 0.688 | 0.375-1.263 | 0.228 | |||
| Gastrointestinal irAEs | 0.939 | 0.347-2.544 | 0.902 | |||
| Fatigue irAEs | 0.390 | 0.176-0.899 | 0.021a | 0.410 | 0.181-0.927 | 0.032a |
| IrAEs number | 0.532 | 0.384-0.736 | <0.001a | 0.547 | 0.389-0.769 | 0.001a |
| irAEs grade | 0.678 | 0.438-1.049 | 0.081 | |||
| OS | ||||||
| Any irAEs | 0.366 | 0.191-0.699 | 0.002a | 0.462 | 0.235-0.909 | 0.025a |
| Skin irAEs | 0.257 | 0.124-0.535 | <0.001a | 0.288 | 0.132-0.628 | 0.002a |
| Endocrine irAEs | 0.258 | 0.061-1.087 | 0.065 | |||
| Hepatobiliary irAEs | 0.497 | 0.195-1.264 | 0.142 | |||
| Gastrointestinal irAEs | 0.806 | 0.217-2.991 | 0.747 | |||
| Fatigue irAEs | 0.186 | 0.044-0.779 | 0.021a | 0.252 | 0.085-1.092 | 0.065 |
| IrAEs number | 0.450 | 0.288-0.705 | <0.001a | 0.529 | 0.326-0.857 | 0.01a |
| IrAEs grade | 0.514 | 0.293-0.903 | 0.021a | 0.641 | 0.357-1.151 | 0.136 |
Abbreviations: irAEs, immune-related adverse events; PFS, progression-free survival; OS, overall survival; HR, hazard ratio, CI, confidence interval
a P value < 0.05
b Covariables included metastasis stage (yes versus no), LDH levels (≤UNL versus>UNL), and liver metastases (yes versus no).