Table 1.
Baseline patient and disease characteristics
| Characteristics | Patients |
|---|---|
| Population size n | 119 |
| Age years | |
| Median (range) | 69 (38-89) |
| Sex n (%) | |
| Female | 23 (19) |
| Male | 96 (81) |
| ECOG-PS n (%) | |
| 0 | 22 (18) |
| 1 | 77 (65) |
| 2 | 19 (16) |
| 3 | 1 (1) |
| Smoking status n (%) | |
| Never | 31 (26) |
| Ever | 84 (71) |
| Current | 16 (13) |
| Former | 68 (57) |
| Missing | 4 (3) |
| Body mass index n (%) | |
| <25 | 41 (34) |
| ≥25 | 78 (66) |
| Primary tumor site n (%) | |
| Bladder | 104 (87) |
| Renal pelvis | 9 (8) |
| Ureter | 6 (5) |
| Histology n (%) | |
| Usual urothelial carcinoma | 103 (87) |
| Urothelial carcinoma variants | 7 (7) |
| Micropapillary | 1 (1) |
| Plasmacytoid | 4 (4) |
| Clear cell | 1 (1) |
| Nested | 1 (1) |
| Mixed | 9 (8) |
| Urothelial carcinoma plus squamous | 5 (4) |
| Urothelial carcinoma plus squamous and adenocarcinoma | 1 (1) |
| Urothelial carcinoma plus squamous and sarcomatoid | 1 (1) |
| Urothelial carcinoma plus squamous and neuroendocrine | 1 (1) |
| Urothelial carcinoma plus adenocarcinoma | 1 (1) |
| Histological grade at diagnosis n (%) | |
| Low | 10 (8) |
| High | 107 (90) |
| Missing | 2 (2) |
| TNM stage at diagnosis n (%) | |
| 0a | 2 (2) |
| I | 20 (17) |
| II | 16 (13) |
| III | 30 (25) |
| IV | 49 (41) |
| Missing | 2 (2) |
| TNM stage IV at ICI initiation n (%) | 119 (100) |
| Site of metastases n (%) | |
| Liver | 21 (18) |
| Lung | 46 (39) |
| Bone | 37 (31) |
| Lymph node | 83 (70) |
| Peritoneum | 16 (13) |
| Brain | 2 (2) |
| Othera | 13 (11) |
| Number of metastatic sites n (%) | |
| 1 | 51 (43) |
| 2 | 41 (34) |
| 3 | 21 (18) |
| 4 | 6 (5) |
| Intravesical BCG administered n (%) | 100 (84) |
| Previous primary tumor resection n (%) | 72 (61) |
| Cystectomy | 59 (50) |
| Nephroureterectomy | 13 (11) |
| Cisplatin ineligibility n (%) | 62 (52) |
| Renal impairment | 44 (37) |
| Ischemic cardiomyopathy | 10 (8) |
| Peripheral arteriopathy | 3 (3) |
| ECOG-PS 2 | 8 (7) |
| Frailty | 3 (3) |
| Previous therapy with platinum-based regimen n (%) | 105 (88) |
| Cisplatin plus gemcitabine | 44 (37) |
| Carboplatin plus gemcitabine | 52 (44) |
| MVAC | 3 (3) |
| Carboplatin | 3 (3) |
| Carboplatin plus paclitaxel | 3 (3) |
| Number of previous systemic regimens in the metastatic setting n (%) | |
| 0 | 22 (18) |
| 1 | 86 (72) |
| 2 | 7 (6) |
| 3 | 3 (3) |
| 4 | 1 (1) |
| Immune checkpoint antibody n (%) | |
| Atezolizumab | 80 (67) |
| Pembrolizumab | 29 (24) |
| Nivolumab | 7 (6) |
| Durvalumab | 3 (3) |
| Radiotherapy n (%) | |
| Yes | 11 (9) |
| No | 108 (91) |
| Albumin n (%) | |
| <3.5 g/dl | 13 (11) |
| ≥3.5 g/dl | 102 (86) |
| Missing | 4 (3) |
| LDH n (%) | |
| ≤ULN | 83 (70) |
| >ULN | 35 (29) |
| Missing | 1 (1) |
| Hemoglobin n (%) | |
| <10 g/dl | 16 (13) |
| ≥10 g/dl | 103 (87) |
| Platelet count n (%) | |
| <400 000/μl | 106 (89) |
| ≥400 000/μl | 13 (11) |
| dNLR n (%) | |
| ≥3 | 23 (19) |
| <3 | 96 (81) |
| Antibiotic use n (%) | |
| Yes | 11 (9) |
| No | 108 (91) |
| Steroid usebn (%) | |
| Yes | 7 (6) |
| No | 112 (94) |
| PPI use n (%) | |
| Yes | 54 (45) |
| No | 65 (55) |
| Number of Bellmunt risk factors n (%) | |
| 0 | 19 (16) |
| 1 | 69 (58) |
| 2 | 30 (25) |
| 3 | 1 (1) |
BCG, Bacillus Calmette-Guérin; dNLR, derived neutrophil-lymphocyte ratio; ECOG-PS, Eastern Cooperative Oncology Group performance status; ICI, immune checkpoint inhibitor; LDH, lactate dehydrogenase; MVAC, methotrexate, vinblastine, adriamycin, and cisplatin; PPI, proton-pump inhibitors; TNM, tumor-node-metastasis; ULN, upper limit of normal.
a
Adrenal gland, pancreas, pericardium, soft tissue, ureter, and surgery site.
b
≥10 mg of prednisone or equivalent.