Baseline clinical and demographic characteristics by CrCl and histology status
| Baseline characteristics | All treated patients (n=214) | Baseline CrCl, mL/min* | Histology type | ||||
| <30 (n=13) | 30–45 (n=37) | 45–60 (n=52) | ≥60 (n=111) | UC (n=190) | UC with MVH (n=24) | ||
| Median age, years | 69 | 74 | 76 | 69 | 67 | 69 | 67 |
| Range | 42–92 | 50–92 | 61–91 | 55–83 | 42–81 | 44–92 | 42–88 |
| Age group, n (%) | |||||||
| <65 years | 68 (32) | 2 (15) | 3 (8.1) | 15 (29) | 48 (43) | 60 (32) | 8 (33) |
| 65–79 years | 117 (55) | 8 (62) | 21 (57) | 28 (54) | 59 (53) | 102 (54) | 15 (63) |
| ≥80 years | 29 (14) | 3 (23) | 13 (35) | 9 (17) | 4 (3.6) | 28 (15) | 1 (4.2) |
| Male, n (%) | 162 (76) | 8 (62) | 21 (57) | 41 (79) | 91 (82) | 146 (77) | 16 (67) |
| Race, n (%) | |||||||
| Asian | 8 (3.7) | 1 (7.7) | 0 | 4 (7.7) | 3 (2.7) | 8 (4.2) | 0 |
| Black or African American | 10 (4.7) | 1 (7.7) | 1 (2.7) | 4 (7.7) | 4 (3.6) | 8 (4.2) | 2 (8.3) |
| White | 192 (90) | 11 (85) | 34 (92) | 44 (85) | 102 (92) | 170 (89) | 22 (92) |
| Unknown | 4 (1.9) | 0 | 2 (5.4) | 0 | 2 (1.8) | 4 (2.1) | 0 |
| Tobacco use history, n (%) | |||||||
| Current | 20 (9.3) | 2 (15) | 1 (2.7) | 3 (5.8) | 14 (13) | 19 (10) | 1 (4.2) |
| Former | 121 (57) | 5 (38) | 21 (57) | 31 (60) | 64 (58) | 102 (54) | 19 (79) |
| Never | 73 (34.1) | 6 (46) | 15 (41) | 18 (35) | 33 (30) | 69 (36) | 4 (17) |
| ECOG PS, n (%) | |||||||
| 0 | 91 (43) | 4 (31) | 17 (46) | 27 (52) | 42 (38) | 84 (44) | 7 (29) |
| 1 | 103 (48) | 8 (62) | 16 (43) | 21 (40) | 58 (52) | 89 (47) | 14 (58) |
| 2 | 18 (8.4) | 1 (7.7) | 4 (10.8) | 4 (7.7) | 9 (8.1) | 15 (7.9) | 3 (13) |
| 3 | 2 (0.9) | 0 | 0 | 0 | 2 (1.8) | 2 (1.1) | 0 |
| PD-L1 status, n† | 73 | 5 | 16 | 17 | 35 | 65 | 8 |
| PD-L1 IC0/1, n (%) | 34 (47) | 0 | 8 (50) | 9 (53) | 17 (49) | 31 (48) | 3 (38) |
| PD-L1 IC2/3, n (%) | 37 (51) | 5 (100) | 8 (50) | 8 (47) | 16 (46) | 33 (51) | 4 (50) |
*One patient had missing CrCl status.
†"PD-L1 status was not evaluable in 2.7% of these patients (n = 2; both patients had ≥60 mL/min CrCl, and 1 each had UC and MVH). Percent PD-L1 expression on IC per central evaluation using the VENTANA SP142 immunohistochemistry assay: IC0/1 (<5%), IC2/3 (≥5%).
CrCl, creatinine clearance; ECOG PS, Eastern Cooperative Oncology Group performance status; IC, immune cell; MVH, mixed variant histology; PD-L1, programmed death ligand 1.