Table 1.
Patient characteristics at baseline in CheckMate 214.
| Patients with IMDC intermediate- and poor-risk RCC | Total (N = 847) |
|---|---|
| Age, median (range), years | 61 (21-85) |
| Age category | |
| <65 years | 524 (61.9) |
| ≥65 years | 323 (38.1) |
| Sex, n (%) | |
| Male | 615 (72.6) |
| Female | 232 (27.4) |
| Geographic region, n (%) | |
| United States | 223 (26.3) |
| Canada and Europe | 294 (34.7) |
| Rest of the world | 330 (39.0) |
| IMDC prognostic risk, n (%) | |
| Intermediate | 667 (79) |
| Poor | 180 (21) |
| Quantifiable tumor PD-L1 expression | |
| <1% | 562 (66.4) |
| ≥1% | 214 (25.3) |
| Not reported | 71 (8.4) |
| Karnofsky performance status | |
| ≥90 | 581 (68.6) |
| <90 | 266 (31.4) |
| LDH level | |
| ≤1.5 × ULN | 787 (92.9) |
| >1.5 × ULN | 45 (5.3) |
| Not reported | 15 (1.8) |
| Prior radiotherapy | |
| Yes | 104 (12.3) |
| No | 743 (87.7) |
| Prior nephrectomy | |
| Yes | 660 (77.9) |
| No | 187 (22.1) |
| Time from initial diagnosis to randomization | |
| <1 year | 590 (69.7) |
| ≥1 year | 257 (30.3) |
| FKSI-19 scores | |
| Total score (n = 813) | 59.6 |
| FKSI-19 DRS (n = 814) | 30.4 |
| FKSI-19 DRS-P (n = 815) | 38.6 |
| FKSI-19 FWB (n = 814) | 7.6 |
Abbreviations: DRS, disease-related symptoms; DRS-P, disease-related symptoms-physical; FKSI-19, Functional Assessment of Cancer Therapy-Kidney Symptom Index-19; FWB, function/well-being; IMDC, International Metastatic Renal Cell Carcinoma Database Consortium; LDH, lactate dehydrogenase; PD-L1, programmed cell death ligand 1; RCC, renal cell carcinoma; ULN, upper limit of normal.