Table 1.
Baseline Demographic and Clinical Characteristics of the Patients Who Underwent Randomization.*
| Characteristic | IMDC Intermediate- and Poor-Risk Patients | Intention-to-Treat Population | ||
|---|---|---|---|---|
| Nivolumab plus Ipilimumab (N = 425) |
Sunitinib (N = 422) |
Nivolumab plus Ipilimumab (N = 550) |
Sunitinib (N = 546) |
|
|
| ||||
| Median age (range) — yr | 62 (26-85) | 61 (21-85) | 62 (26-85) | 62 (21-85) |
|
| ||||
| Sex — no. (%) | ||||
|
| ||||
| Male | 314(74) | 301 (71) | 413 (75) | 395 (72) |
|
| ||||
| Female | 111 (26) | 121 (29) | 137 (25) | 151 (28) |
|
| ||||
| IMDC prognostic risk — no. (%)† | ||||
|
| ||||
| Favorable | 0 | 0 | 125 (23) | 124 (23) |
|
| ||||
| Intermediate | 334 (79) | 333 (79) | 334 (61) | 333 (61) |
|
| ||||
| Poor | 91 (21) | 89 (21) | 91 (17) | 89 (16) |
|
| ||||
| Geographic region — no. (%) | ||||
|
| ||||
| United States | 112 (26) | 111 (26) | 154 (28) | 153 (28) |
|
| ||||
| Canada and Europe | 148 (35) | 146 (35) | 201 (37) | 199 (36) |
|
| ||||
| Rest of the world | 165 (39) | 165 (39) | 195 (35) | 194 (36) |
|
| ||||
| Quantifiable tumor PD-L1 expression — no./ total no. with evaluable data (%) | ||||
|
| ||||
| <1% | 284/384 (74) | 278/392 (71) | 386/499(77) | 376/503 (75) |
|
| ||||
| ≥1% | 100/384 (26) | 114/392 (29) | 113/499 (23) | 127/503 (25) |
|
| ||||
| Previous radiotherapy — no. (%) | 52 (12) | 52 (12) | 63 (11) | 70 (13) |
|
| ||||
| Previous nephrectomy — no. (%) | 341 (80) | 319 (76) | 453 (82) | 437 (80) |
|
| ||||
| No. of sites with target or nontarget lesions — no. (%)‡ | ||||
|
| ||||
| 1 | 90 (21) | 84 (20) | 123 (22) | 118 (22) |
|
| ||||
| ≥2 | 335 (79) | 337 (80) | 427 (78) | 427 (78) |
|
| ||||
| Most common sites of metastasis — no. (%) | ||||
|
| ||||
| Lung | 294 (69) | 296 (70) | 381 (69) | 373 (68) |
|
| ||||
| Lymph node | 190 (45) | 216 (51) | 246 (45) | 268 (49) |
|
| ||||
| Bone§ | 95 (22) | 97 (23) | 112 (20) | 119 (22) |
|
| ||||
| Liver | 88 (21) | 89 (21) | 99 (18) | 107 (20) |
Information shown in the table is based on data collected with the use of an interactive voice-response system. Percentages may not total 100 because of rounding. IMDC denotes International Metastatic Renal Cell Carcinoma Database Consortium, and PD-L1 programmed death ligand 1.
Patients with favorable risk had an IMDC score of 0, those with intermediate risk had a score of 1 or 2, and those with poor risk had a score of 3 to 6. IMDC risk scores are defined by the number of the following risk factors present: a Karnofsky performance-status score of 70 (on a scale from 0 to 100, with lower scores indicating greater disability; patients with a performance-status score of <70 were excluded from the trial), a time from initial diagnosis to randomization of less than 1 year, a hemoglobin level below the lower limit of the normal range, a corrected serum calcium concentration of more than 10 mg per deciliter (2.5 mmol per liter), an absolute neutrophil count above the upper limit of the normal range, and a platelet count above the upper limit of the normal range.
The number of target or nontarget lesions at baseline was not reported for one patient in the sunitinib group.
Shown are patients who had bone metastases with or without a soft-tissue component.