Table 1.
Patient baseline characteristics
| Characteristic | Pembrolizumab N = 30 |
Chemotherapy N = 22 |
|---|---|---|
| Age (years), median (range) | 72 (51–83) | 70.5 (56–84) |
| Sex, n (%) | ||
| Male | 24 (80.0) | 16 (72.7) |
| Geographic location of disease, n (%) | ||
| Upper tract | 12 (40.0) | 5 (22.7) |
| Lower tract | 18 (60.0) | 17 (77.3) |
| ECOG PS, n (%) | ||
| 0 | 23 (76.7) | 14 (63.6) |
| 1 | 7 (23.3) | 7 (31.8) |
| 2 | 0 (0) | 1 (4.5) |
| Visceral disease, n (%) | 25 (83.3) | 14 (63.6) |
| Disease in lymph node only, n (%) | 5 (17.7) | 8 (36.4) |
| Liver metastases, n (%) | 7 (23.3) | 4 (18.2) |
| Hemoglobin < 10 g/dL,an (%) | 8 (26.7) | 4 (18.2) |
| Time since completion of most recent prior therapy, n (%) | ||
| ≥ 3 months | 17 (56.7) | 10 (45.5) |
| < 3 months | 13 (43.3) | 12 (54.5) |
| Setting of most recent prior therapy, n (%) | ||
| Neoadjuvant | 1 (3.3) | 2 (9.1) |
| Adjuvant | 1 (3.3) | 4 (18.2) |
| First line | 24 (80.0) | 12 (54.5) |
| Second line | 4 (13.3) | 4 (18.2) |
| Prior platinum-based therapy, n (%) | ||
| Cisplatin | 24 (80.0) | 18 (81.8) |
| Carboplatin | 6 (20.0) | 2 (9.1) |
| Otherb | 0 (0) | 2 (9.1) |
| Smoking status, n (%) | ||
| Never | 13 (43.3) | 8 (36.4) |
| Former | 15 (50.0) | 12 (54.5) |
| Current | 2 (6.7) | 2 (9.1) |
| PD-L1 CPS ≥ 10, n (%) | 4 (13.3) | 8 (36.4) |
| Risk factors,cn (%) | ||
| 0 | 8 (26.7) | 4 (18.2) |
| 1 | 13 (43.3) | 10 (45.5) |
| 2 | 5 (16.7) | 6 (27.3) |
| 3 or 4 | 4 (13.3) | 2 (9.1) |
| EORTC QLQ-C30 global health status/QOL score | 57.8 (25.4) | 54.9 (27.4) |
CPS combined positive score, ECOG PS Eastern Cooperative Oncology Group performance status, EORTC QLQ-C30 European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30, PD-L1 programmed death ligand-1, QOL quality of life
aLatest hemoglobin test value before or on randomization date
bOxaliplatin, nedaplatin
cBellmunt risk factors of ECOG PS > 0, hemoglobin level < 10 g/dL, and liver metastases [31] + time from prior chemotherapy < 3 months [32]