Table 1.
Characteristics of the patients at baseline
| Intention-to-treat population | ||
|---|---|---|
| Atezolizumab (n = 406) |
Observation (n = 403) |
|
| Median age (interquartile range), years | 67 (60-72) | 66 (60-73) |
| Race | ||
| White | 320 (79%) | 307 (76%) |
| Asian | 64 (16%) | 68 (17%) |
| Black or African American | 3 (1%) | 3 (1%) |
| American Indian or Alaska Native | 1 (< 1%) | 0 |
| Other/Unknown | 18 (4%) | 25 (6%) |
| Male | 322 (79%) | 316 (78%) |
| Region | ||
| North America | 115 (28%) | 126 (31%) |
| Europe | 227 (56%) | 210 (52%) |
| Asia | 61 (15%) | 64 (16%) |
| Australia | 3 (1%) | 3 (1%) |
| Primary tumour site | ||
| Bladder | 377 (93%) | 378 (94%) |
| Upper tract (ureter, renal pelvis) | 29 (7%) | 25 (6%) |
| Pathologic tumour stage* | ||
| ≤ pT2 | 104 (26%) | 101 (25%) |
| pT3/4 | 302 (74%) | 302 (75%) |
| Pathologic nodal status* | ||
| Positive | 212 (52%) | 208 (52%) |
| Negative | 194 (48%) | 195 (48%) |
| Tumour stage and N0 nodal status† | ||
| pT2N0 | 34 (8%) | 39 (10%) |
| pT3N0 | 124 (31%) | 119 (30%) |
| pT4N0 | 32 (8%) | 33 (8%) |
| No. of lymph nodes resected* | ||
| < 10 | 95 (23%) | 94 (23%) |
| ≥ 10 | 311 (77%) | 309 (77%) |
| Eastern Cooperative Oncology Group performance status | ||
| 0 | 248 (61%) | 259 (64%) |
| 1 | 142 (35%) | 130 (32%) |
| 2 | 16 (4%) | 14 (3%) |
| Age-adjusted Charlson Comorbidity Index‡ | ||
| 0-1 | 55 (14%) | 61 (15%) |
| 2-3 | 135 (34%) | 150 (37%) |
| ≥ 4 | 210 (53%) | 190 (47%) |
| PD-L1 IHC status*,§ | ||
| IC0/1 | 210 (52%) | 207 (51%) |
| IC2/3 | 196 (48%) | 196 (49%) |
| Prior neoadjuvant chemotherapy* | ||
| Yes | 196 (48%) | 189 (47%) |
| No | 210 (52%) | 214 (53%) |
Data are n (%) unless otherwise stated. Percentages may not add to 100% due to rounding.
Per interactive voice/web response system.
Per electronic case report form.
Percentages based on 400 patients in the atezolizumab arm and 401 patients in the observation arm.
Archival and/or fresh pre-treatment formalin-fixed paraffin-embedded tumour tissue from all patients (surgical resection or lymph node dissection) were prospectively tested for PD-L1 status per a central laboratory and used as a stratification factor. A total of 119 patients were enrolled under a protocol using IC2/3 selection; 690 patients were enrolled under an “all-comer” protocol that enrolled 273 patients with IC2/3 tumours (40%) and 417 patients with IC0/1 tumours (60%).