Table 1.
Baseline Demographic and Clinical Characteristics of the Patients Who Underwent Randomization.*
| Characteristic | Patients with PD-L1–Positive Tumors | Overall Population | ||
|---|---|---|---|---|
| Avelumab plus Axitinib (N = 270) |
Sunitinib (N = 290) |
Avelumab plus Axitinib (N = 442) |
Sunitinib (N = 444) |
|
| Median age (range) — yr | 62.0 (29.0–83.0) | 60.5 (27.0–88.0) | 62.0 (29.0–83.0) | 61.0 (27.0–88.0) |
| Sex — no. (%) | ||||
| Male | 203 (75.2) | 224 (77.2) | 316 (71.5) | 344 (77.5) |
| Female | 67 (24.8) | 66 (22.8) | 126 (28.5) | 100 (22.5) |
| MSKCC prognostic risk group — no. (%)† | ||||
| Favorable | 52 (19.3) | 60 (20.7) | 96 (21.7) | 100 (22.5) |
| Intermediate | 180 (66.7) | 201 (69.3) | 283 (64.0) | 293 (66.0) |
| Poor | 33 (12.2) | 24 (8.3) | 51 (11.5) | 45 (10.1) |
| Not reported | 5 (1.9) | 5 (1.7) | 12 (2.7) | 6 (1.4) |
| IMDC prognostic risk group — no. (%)‡ | ||||
| Favorable | 52 (19.3) | 59 (20.3) | 94 (21.3) | 96 (21.6) |
| Intermediate | 173 (64.1) | 191 (65.9) | 271 (61.3) | 276 (62.2) |
| Poor | 44 (16.3) | 39 (13.4) | 72 (16.3) | 71 (16.0) |
| Not reported | 1 (0.4) | 1 (0.3) | 5 (1.1) | 1 (0.2) |
| Geographic region — no. (%) | ||||
| United States | 75 (27.8) | 82 (28.3) | 128 (29.0) | 130 (29.3) |
| Canada and Western Europe | 80 (29.6) | 81 (27.9) | 128 (29.0) | 128 (28.8) |
| Rest of the world | 115 (42.6) | 127 (43.8) | 186 (42.1) | 186 (41.9) |
| Previous nephrectomy — no. (%) | ||||
| Yes | 233 (86.3) | 252 (86.9) | 352 (79.6) | 355 (80.0) |
| No | 37 (13.7) | 38 (13.1) | 90 (20.4) | 89 (20.0) |
| RECIST-defined tumor sites at baseline, according to independent review — no. (%) | ||||
| 0 | 8 (3.0) | 11 (3.8) | 11 (2.5) | 16 (3.6) |
| 1 | 120 (44.4) | 118 (40.7) | 181 (41.0) | 174 (39.2) |
| 2 | 85 (31.5) | 101 (34.8) | 148 (33.5) | 151 (34.0) |
| 3 | 40 (14.8) | 50 (17.2) | 67 (15.2) | 79 (17.8) |
| ≥4 | 17 (6.3) | 10 (3.4) | 35 (7.9) | 24 (5.4) |
Percentages may not total 100 because of rounding. RECIST denotes Response Evaluation Criteria in Solid Tumors.
Patients with favorable risk had a Memorial Sloan Kettering Cancer Center (MSKCC) score of 0, those with intermediate risk had a score of 1 or 2, and those with poor risk had a score of 3 or more. MSKCC risk scores are defined according to the number of the following risk factors present: a Karnofsky performance-status score of less than 80 (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), less than 1 year from the time of initial diagnosis to the start of therapy, a hemoglobin level below the lower limit of the normal range, a lactate dehydrogenase level more than 1.5 times the upper limit of the normal range, and a corrected serum calcium concentration of more than 10 mg per deciliter (2.5 mmol per liter).
Patients with favorable risk had an International Metastatic Renal Cell Carcinoma Database Consortium (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 according to the number of the following risk factors present: a Karnofsky performance-status score of less than 80, time from initial diagnosis to randomization of less than 1 year, hemoglobin level below the lower limit of the normal range, corrected serum calcium level above the upper limit of the normal range, absolute neutrophil count above the upper limit of the normal range, and platelet count above the upper limit of the normal range.