Table 2.
Cox proportional hazards regression results
| Univariate | Multivariable | |||||||
| PFS | OS | PFS | OS | |||||
| HR (95% CI) | P value | HR (95% CI) | P value | HR (95% CI) | P value | HR (95% CI) | P value | |
| ≥20% ICI infusions prior to noon | 0.67 (0.48 to 0.94) | 0.020 | 0.57 (0.34 to 0.95) | 0.033 | 0.70 (0.50 to 0.98) | 0.040 | 0.57 (0.33 to 0.98) | 0.043 |
| Age (per year) | 1.00 (0.99 to 1.02) | 0.543 | 1.00 (0.98 to 1.02) | 0.910 | 1.01 (0.99 to 1.02) | 0.339 | 1.01 (0.98 to 1.03) | 0.651 |
| Male (vs female) | 0.82 (0.57 to 1.19) | 0.300 | 0.97 (0.55 to 1.72) | 0.928 | 0.85 (0.58 to 1.26) | 0.421 | 1.00 (0.55 to 1.83) | 0.990 |
| ECOG≥2 (vs <2) | 1.98 (1.30 to 3.03) | 0.002 | 2.91 (1.54 to 5.50) | 0.001 | 1.43 (0.88 to 2.34) | 0.153 | 1.93 (0.92 to 4.02) | 0.081 |
| Statin use | 0.88 (0.62 to 1.25) | 0.475 | 0.91 (0.53 to 1.56) | 0.721 | ||||
| Elevated LDH | 1.89 (1.17 to 3.05) | 0.009 | 3.82 (2.03 to 7.22) | <0.001 | 1.31 (0.77 to 2.22) | 0.327 | 2.28 (1.10 to 4.69) | 0.026 |
| IMDC score (per unit increase) | 1.33 (1.16 to 1.51) | <0.001 | 1.51 (1.22 to 1.86) | <0.001 | 1.26 (1.09 to 1.47) | 0.002 | 1.33 (1.06 to 1.67) | 0.016 |
| Histology | ||||||||
| Clear cell | 0.76 (0.53 to 1.10) | 0.141 | 0.50 (0.29 to 0.86) | 0.012 | 1.03 (0.69 to 1.54) | 0.876 | 0.67 (0.37 to 1.21) | 0.182 |
| Any chromophobe features | 0.73 (0.18 to 2.94) | 0.654 | 1.08 (0.15 to 7.82) | 0.939 | ||||
| Any sarcomatoid features | 1.04 (0.42 to 2.54) | 0.938 | 1.70 (0.52 to 5.48) | 0.378 | ||||
| Bone metastasis | 1.17 (0.82 to 1.68) | 0.384 | 1.31 (0.76 to 2.23) | 0.329 | 1.01 (0.69 to 1.48) | 0.953 | 1.13 (0.63 to 2.06) | 0.677 |
| Brain metastasis | 1.13 (0.67 to 1.91) | 0.647 | 0.68 (0.27 to 1.70) | 0.408 | 0.97 (0.56 to 1.68) | 0.908 | 0.60 (0.23 to 1.55) | 0.290 |
| Liver metastasis | 1.42 (0.98 to 2.06) | 0.064 | 2.19 (1.28 to 3.75) | 0.004 | 1.41 (0.96 to 2.08) | 0.078 | 1.92 (1.08 to 3.41) | 0.027 |
| First-line therapy included ICI | 0.82 (0.57 to 1.17) | 0.279 | 0.64 (0.35 to 1.15) | 0.136 | ||||
| Initial ICI regimen | ||||||||
| Dual ipi/nivo | (Reference) | |||||||
| Nivolumab | 1.01 (0.70 to 1.47) | 0.954 | 1.30 (0.71 to 2.38) | 0.397 | ||||
| Nivolumab+TKI | 0.68 (0.34 to 1.34) | 0.262 | 1.21 (0.45 to 3.29) | 0.706 | ||||
| Pembrolizumab | 0.76 (0.27 to 2.12) | 0.603 | 0.73 (0.10 to 5.47) | 0.757 | ||||
| Pembrolizumab+TKI | 1.01 (0.43 to 2.36) | 0.986 | 2.29 (0.67 to 7.84) | 0.188 | ||||
| Ever received | ||||||||
| Nivolumab | 0.97 (0.69 to 1.37) | 0.856 | 1.20 (0.70 to 2.09) | 0.506 | ||||
| Pembrolizumab | 0.78 (0.46 to 1.34) | 0.377 | 0.84 (0.36 to 1.97) | 0.693 | ||||
| Dual ipi/nivo | 1.07 (0.75 to 1.52) | 0.724 | 0.74 (0.42 to 1.32) | 0.314 | ||||
| Cabozantinib | 1.31 (0.93 to 1.84) | 0.119 | 1.37 (0.81 to 2.32) | 0.241 | ||||
| Pazopanib | 1.15 (0.81 to 1.65) | 0.435 | 0.94 (0.54 to 1.64) | 0.827 | ||||
| Sunitinib | 0.93 (0.59 to 1.47) | 0.752 | 1.16 (0.61 to 2.23) | 0.647 | ||||
| Everolimus | 1.32 (0.87 to 2.00) | 0.191 | 1.43 (0.79 to 2.59) | 0.232 | ||||
| Lenvatinib | 1.25 (0.77 to 2.03) | 0.368 | 0.89 (0.42 to 1.88) | 0.758 | ||||
| Axitinib | 1.56 (0.89 to 2.72) | 0.118 | 0.67 (0.21 to 2.14) | 0.495 | ||||
ECOG, Eastern Cooperative Oncology Group performance status; ICI, immune checkpoint inhibitor; IMDC, International Metastatic renal cell carcinoma Database Consortium; ipi, ipilimumab; LDH, lactate dehydrogenase; nivo, nivolumab; OS, overall survival; PFS, progression-free survival; TKI, tyrosine kinase inhibitor.