TABLE 1.
Patient Demographics and Baseline Characteristics
| Characteristic | Cohort 3 (N = 41) |
|---|---|
| Age, years, median (range) | 67 (46-86) |
| ≥65, No. (%) | 26 (63) |
| Male, No. (%) | 34 (83) |
| Race, No. (%) | |
| White | 22 (54) |
| Other | 1 (2) |
| Not reported | 18 (44) |
| ECOG PS score, No. (%) | |
| 0 | 16 (39) |
| 1 | 25 (61) |
| Type of disease, No. (%) | |
| Metastatic urothelial cancer | 32 (78) |
| Locally advanced unresectable | 9 (22) |
| Visceral metastases, No. (%) | 32 (78) |
| Lung/pleura | 22 (54) |
| Liver | 12 (29) |
| Other | 8 (20) |
| Time since initial diagnosis, months, median (range) | 13.5 (2.3-98.1) |
| Prior anticancer regimens, No. (%) | |
| 1 | 32 (78) |
| 2 | 9 (22) |
| Duration of last anticancer regimen, months, median (range) | 2.7 (0-13) |
| Prior platinum-based chemotherapy, No. (%) | |
| Cisplatin | 29 (71) |
| Carboplatin | 12 (29) |
| Setting of last prior systemic therapy, No. (%) | |
| (Neo)adjuvant | 17 (41) |
| Metastatic | 24 (59) |
| Time since the end of last prior systemic therapy, months, median (range) | |
| (Neo)adjuvant | 7.2 (2.5-12.8) |
| Metastatic | 2.0 (0.3-60.6) |
| Best response to prior systemic platinum therapy with metastatic intent, No. | 24 |
| CR, No. (%) | 1 (4) |
| PR, No. (%) | 2 (8) |
| SD, No. (%) | 13 (54) |
| PD, No. (%) | 6 (25) |
| Not reported/NA, No. (%) | 2 (8) |
| Bellmunt risk factors | |
| 0, No. (%) | 10 (24) |
| 1, No. (%) | 20 (49) |
| 2, No. (%) | 11 (27) |
| 3, No. | 0 |
| UGT1A1 status, No. | 35 |
| Wild type *1/*1, No. (%) | 13 (37) |
| Heterozygous *1/*28, No. (%) | 15 (43) |
| Homozygous *28/*28, No. (%) | 7 (20) |
| Missing, No. | 6 |
Abbreviations: CR, complete response; ECOG PS, Eastern Cooperative Oncology Group performance status; NA, not available; PD, progressive disease; PR, partial response; SD, stable disease.