Table 1.
Baseline characteristics of the entire cohort (n = 761) and comparative analysis by PD-L1 expression status.
| Variables | Total (n = 761) | Negative PD-L1 (<5%) (n = 548, 72%) | Positive PD-L1 (≥5%) (n = 213, 28%) | P-value |
|---|---|---|---|---|
| Clinical parameters | ||||
| Age at surgery, years, median (IQR) <70 ≥70 |
70 (62–77) 369 (48%) 392 (52%) |
258 (47%) 290 (52%) |
111 (52%) 102 (48%) |
0.23 |
| Sex, n (%) | ||||
| Male Female |
619 (81%) 142 (19%) |
440 (80 %) 108 (20%) |
179 (84%) 34 (16%) |
0.25 |
| Smoking status at diagnosis, n (%) | ||||
| No smoking history Smoking history (ex-or current) Missing |
318 (42%) 323 (42%) 120 (16%) |
246 (45%) 248 (45%) 53 (10%) |
72 (34%) 74 (34%) 67 (32%) |
<0.01 |
| Intravesical chemotherapy prior to VENTANA, n (%) | ||||
| No Yes |
705 (93%) 56 (7%) |
507 (93%) 41 (7%) |
198 (93.0%) 15 (7.0%) |
0.88 |
| Intravesical BCG prior to VENTANA, n (%) | ||||
| No Yes |
655 (86%) 106 (14%) |
463 (84%) 85 (16%) |
192 (90%) 21 (10%) |
0.04 |
| Systemic chemotherapy prior to VENTANA, n (%) | ||||
| No Yes |
646 (85%) 115 (15%) |
471 (86%) 77 (14%) |
175 (82%) 38 (18%) |
0.21 |
| Metastasis, n (%) | ||||
| No Lymph node only Distant (lung, liver, bone, colon, etc.) |
495 (65%) 127 (17%) 139 (18%) |
368 (67%) 81 (15%) 99 (18%) |
127 (59%) 46 (22%) 40 (19%) |
0.06 |
| VENTANA related parameters | ||||
| Specimen type, n (%) | ||||
| TUR (pre-BCG) TUR (post-BCG) Cystectomy (radical or partial) Nephroureterectomy or ureterectomy Biopsy for primary lesion Biopsy for metastatic lesion |
344 (45%) 72 (9%) 203 (27%) 100 (13%) 23 (3%) 19 (3%) |
274 (50%) 64 (12%) 97 (18%) 74 (13%) 23 (4%) 16 (3%) |
70 (33%) 8 (4%) 106 (50%) 26 (12%) 0 (0%) 3 (1%) |
<0.01 |
| Organ type, n (%) | ||||
| Lower tract (bladder or urethra) Upper tract (renal pelvis or ureter) Metastatic site |
633 (83%) 109 (14%) 19 (3%) |
449 (82%) 83 (15%) 16 (3%) |
184 (86%) 26 (12%) 3 (2%) |
0.27 |
| Operation type, n (%) | ||||
| TUR Cystectomy (radical or partial) Nephroureterectomy or ureterectomy Biopsy |
416 (55%) 203 (27%) 100 (13%) 42 (5%) |
338 (62%) 97 (18%) 74 (13%) 39 (7%) |
78 (37%) 106 (50%) 26 (12%) 3 (1%) |
<0.01 |
| Pathologic stage, n (%) | ||||
| Organ confined (stage I/II) Non-organ confined (stage III/IV) |
500 (66%) 261 (34%) |
384 (70%) 164 (30%) |
116 (55%) 97 (45%) |
<0.01 |
| Pathologic grade, n (%) | ||||
| Low grade High grade |
101 (13%) 660 (87%) |
94 (17%) 454 (83%) |
7 (3%) 206 (97%) |
<0.01 |
| Time from tissue acquisition to VENTANA, n (%) | ||||
| <1 month ≥1 month |
501 (66%) 260 (34%) |
364 (66%) 184 (34%) |
137 (64%) 76 (36%) |
0.61 |
PD-L1, programmed cell death-ligand 1; BCG, bacillus Calmette–Guerin; TUR, transurethral resection; IC, immune cells.