Table 1 -.
Patient baseline characteristics and study disposition.
| Characteristic | Age subgroups |
Age/ECOG PS2 subgroups |
||
|---|---|---|---|---|
| Age ≥65 yr (n = 302) | Age ≥75 yr (n = 179) | Age ≥65 yr + ECOG PS2 (n = 119) | Age ≥75 yr + ECOG PS2 (n = 78) | |
| Baseline characteristics | ||||
| Age (yr), median (range) | 76 (65–94) | 81 (75–94) | 78 (65–91) | 81 (75–91) |
| Sex (men), n (%) | 230 (76) | 137 (77) | 93 (78) | 57 (73) |
| ECOG PS, n (%) | ||||
| 0 or 1 | 183 (61) | 101 (56) | 0 | 0 |
| 2 | 119 (39) | 78 (44) | 119 (100) | 78 (100) |
| 3 | 0 | 0 | 0 | 0 |
| Upper tract primary tumora, n (%) | 57 (19) | 27 (15) | 23 (19) | 14 (18) |
| Metastasis locationb, n (%) | ||||
| Visceral disease | 257 (85) | 154 (86) | 98 (82) | 64 (82) |
| Lymph node disease only | 41 (14) | 21 (12) | 19 (16) | 12 (15) |
| Liver metastases, n (%) | 65 (22) | 43 (24) | 30 (25) | 22 (28) |
| Hemoglobin <10 g/dl, n (%) | 31 (10) | 21 (12) | 15 (13) | 11 (14) |
| Prior chemotherapy, n (%) | 54 (18) | 27 (15) | 22 (19) | 10 (13) |
| Reasons for cisplatin ineligibility, n (%) | ||||
| Renal dysfunction | 154 (51) | 90 (50) | 9 (8) | 7 (9) |
| ECOG PS2 | 87 (29) | 54 (30) | 81 (68) | 49 (63) |
| ECOG PS2 + renal dysfunction | 31 (10) | 22 (12) | 27 (23) | 20 (26) |
| Otherc | 30 (10) | 13 (7) | 2 (2) | 2 (3) |
| Study disposition | ||||
| Completed, n (%) | 34 (11) | 8 (5) | 12 (10) | 5 (6) |
| Discontinued, n (%) | 268 (89) | 171 (96) | 107 (90) | 73 (94) |
| Adverse event | 50 (17) | 34 (19) | 22 (19) | 15 (19) |
| Clinical progression | 36 (12) | 22 (12) | 15 (13) | 9 (12) |
| Complete response | 11 (4) | 7 (4) | 5 (4) | 4 (5) |
| Physician decision | 10 (3) | 8 (5) | 5 (4) | 4 (5) |
| Progressive disease | 142 (47) | 89 (50) | 51 (43) | 36 (46) |
| Withdrawal by patient | 18 (6) | 11 (6) | 8 (7) | 5 (6) |
| Noncompliance with study drug | 1 (<1) | 0 | 1 (1) | 0 |
| Treatment ongoing, n (%) | 0 | 0 | 0 | 0 |
ECOG PS = Eastern Cooperative Oncology Group performance status.
a
Unknown for one patient.
b
Unknown for four patients.
c
Other reasons include New York Heart Association Class III heart failure, grade ≥2 peripheral neuropathy, and grade ≥2 hearing loss.