Table 4.
Twelve‐week landmark multivariable Cox proportional‐hazards regression model for survival
| Variable | PFS | OS | ||
|---|---|---|---|---|
| HR (95% CI) | p value | HR (95% CI) | p value | |
| Age | ||||
| <60 yr | Reference | Reference | ||
| ≥60 yr | 1.2 (0.74–1.93) | .465 | 1.29 (0.76–2.17) | .340 |
| Sex | ||||
| Male | Reference | Reference | ||
| Female | 1.08 (0.68–1.71) | .746 | 0.92 (0.55–1.51) | .731 |
| LDH | ||||
| Normal | Reference | Reference | ||
| Elevated | 1.75 (1.1–2.79) | .019 | 2.34 (1.4–3.92) | .001 |
| BRAF status | ||||
| Normal | Reference | Reference | ||
| Mutant | 0.89 (0.51–1.56) | .690 | 0.53 (0.27–1.03) | .060 |
| ECOG | ||||
| 0 | Reference | Reference | ||
| 1 | 0.77 (0.45–1.3) | .324 | 0.84 (0.45–1.57) | .592 |
| 2+ | 0.85 (0.34–2.14) | .727 | 0.54 (0.16–1.84) | .323 |
| M stage | ||||
| 0/1a | Reference | Reference | ||
| 1b | 1.15 (0.59–2.25) | .674 | 2.38 (1.09–5.18) | .029 |
| 1c | 1.23 (0.68–2.21) | .501 | 1.71 (0.81–3.59) | .160 |
| 1d | 0.9 (0.45–1.8) | .773 | 1.15 (0.49–2.73) | .747 |
| Any irAE | ||||
| No | Reference | Reference | ||
| Yes | 0.75 (0.41–1.37) | .349 | 0.81 (0.42–1.56) | .524 |
| Grade ≥3 irAE | ||||
| No | Reference | Reference | ||
| Yes | 0.73 (0.31–1.74) | .477 | 0.29 (0.1–0.85) | .024 |
| Objective irAE only | ||||
| No | Reference | Reference | ||
| Yes | 0.75 (0.4–1.42) | .378 | 0.58 (0.27–1.23) | .153 |
| Immunomodulatory agent(s) to treat irAE | ||||
| No | Reference | Reference | ||
| Yes | 0.95 (0.46–1.98) | .899 | 1.5 (0.67–3.37) | .324 |
| Line of anti‐PD‐1 | ||||
| 1 | Reference | Reference | ||
| 2 | 0.62 (0.33–1.19) | .150 | 0.79 (0.4–1.55) | .487 |
| 3 | 0.45 (0.25–0.8) | .007 | 0.62 (0.34–1.14) | .125 |
| ≥4 | 0.3 (0.1–0.94) | .039 | 0.69 (0.19–2.47) | .566 |
| Each additional cycle | 0.96 (0.94–0.98) | <.001 | 0.94 (0.91–0.97) | <.001 |
aIncludes TNF‐a inhibitors, mycophenolate mofetil, azathioprine, interleukin‐6 inhibitors, methotrexate, or leflunomide.
Abbreviations: CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; HR, hazard ratio; irAE, immune‐related adverse event; LDH, lactate dehydrogenase; OS, overall survival; PD‐1, programmed cell death protein 1; PFS, progression‐free survival.