Table 1.
Baseline patient characteristics
| All | Prior Anti-PD-(L)1 therapy; Avelumab group | Prior Anti-PD-(L)1 therapy; Pembrolizumab group | p-value | |
|---|---|---|---|---|
| Number of patients | 100 | 21 | 79 | |
| Age, years (Mean, SD) | 73.6 ± 8.6 | 74.3 ± 6.7 | 73.5 ± 9.1 | 0.69 |
| Age ≥ 75 years, no. (%) | 49 (49%) | 10 (47.6%) | 39 (49.3%) | 1.0 |
| Male sex | 67 (67%) | 9 (42.8%) | 58 (73.4%) | 0.016 |
| ECOG | 0.34 | |||
| 0–1 | 82 (82%) | 19 (90.4%) | 63 (79.7%) | |
| ≥ 2 | 18 (18%) | 2 (9.5%) | 16 (20.2%) | |
| Tobacco use, no. (%) | 0.23 | |||
| Former user | 50 (50%) | 8 (38%) | 42 (53.1%) | |
| Current user | 4 (4%) | 0 | 4 (5%) | |
| Never user | 46 (46%) | 13 (61.9%) | 33 (41.7%) | |
| Primary tumor site | 0.62 | |||
| Bladder | 57 (57%) | 11 (52.3%) | 46 (58.2%) | |
| Upper urinary tract | 42 (42%) | 10 (47.6%) | 32 (40.5%) | |
| Missing | 1 (1%) | 0 | 1 (1.2%) | |
| Histologic type | 0.83 | |||
| Urothelial carcinoma | 78 (78%) | 17 (76.1%) | 61 (77.2%) | |
| Urothelial carcinoma with variant histology | 5 (5%) | 0 | 5 (6.3%) | |
| Other | 9 (9%) | 2 (9.5%) | 7 (8.8%) | |
| Missing | 8 (8%) | 2 (9.5%) | 6 (7.5%) | |
| Symptomatic disease | 60 (60%) | 11 (52.3%) | 49 (62%) | 0.61 |
| Missing | 1 (1%) | 1 (4.7%) | 0 | |
| Prior surgery or radiation | 0.52 | |||
| Surgery | 58 (58%) | 10 (47.6%) | 48 (60.7%) | |
| Radiation | 8 (8%) | 2 (9.5%) | 6 (7.5%) | |
| Surgery + Radiation | 3 (3%) | 0 | 3 (3.7%) | |
| None | 31 (31%) | 9 (42.8%) | 22 (27.8%) | |
| Previous chemotherapy | 0.26 | |||
| Cisplatin | 67 (67%) | 17 (80.9%) | 50 (63.2%) | |
| Carboplatin | 23 (23%) | 4 (19%) | 19 (24%) | |
| Other | 8 (8%) | 0 | 8 (10.1%) | |
| NA | 2 (2%) | 0 | 2 (2.5%) | |
| Metastatic disease | ||||
| Visceral metastasis | 64 (64%) | 11 (52.3%) | 53 (67%) | 0.30 |
| Liver | 17 (17%) | 4 (19%) | 13 (16.4%) | 0.75 |
| Lung | 49 (49%) | 6 (28.5%) | 43 (54.4%) | 0.049 |
| Bone | 28 (28%) | 6 (28.5%) | 22 (27.8%) | 1.0 |
| Lymph node | 65 (65%) | 13 (61.9%) | 52 (65.8%) | 0.79 |
| Number of metastasis sites (mean, standard deviation) | 1.9 ± 1.0 | 1.7 ± 1.3 | 2.0 ± 0.91 | 0.31 |
| Number of visceral metastasis sites (mean, standard deviation) | 0.8 ± 0.68 | 0.61 ± 0.66 | 0.84 ± 0.68 | 0.17 |
| Perioperative therapy | 0.84 | |||
| Neoadjuvant chemotherapy | 6 (6%) | 1 (4.7%) | 5 (6.3%) | |
| Adjuvant chemotherapy | 6 (6%) | 2 (9.5%) | 4 (5%) | |
| Salvage chemotherapy | 86 (86%) | 18 (85.7%) | 68 (86%) | |
| Best response among patients who previously received chemotherapy | 0.0035 | |||
| CR | 6 (6%) | 1 (4.7%) | 5 (6.3%) | |
| PR | 26 (26%) | 10 (47.6%) | 16 20.2%) | |
| SD | 30 (30%) | 9 (42.8%) | 21 (26.5%) | |
| PD | 31 (31%) | 1 (4.7%) | 30 (37.9%) | |
| NA | 7 (7%) | 0 | 7 (8.8%) | |
| Best response among patients | 0.97 | |||
| who previously received ICIs | ||||
| CR | 4 (4%) | 0 | 4 (5%) | |
| PR | 15 (15%) | 3 (14.2%) | 12 (15.1%) | |
| SD | 19 (19%) | 4 (19%) | 15 (18.9%) | |
| PD | 60 (60%) | 13 (61.9%) | 47 (59.4%) | |
| Follow-up period, months (Median, range) | 6.7 (0.4–16.6) | 7.6 (0.97–15.5) | 6.4 (0.4–16.6) | 0.35 |
PD-(L)1 programmed death-1 receptor/programmed death ligand-1; ECOG Eastern Cooperative Oncology Group; ICIs immune checkpoint inhibitors; CR complete response; PR partial response; SD stable disease; PD progressive disease; NA not applicable