Table 1. Patient characteristics in the chemotherapy cohorts.
| Neoadjuvant chemotherapy cohort, n=92 | First-line chemotherapy cohort, n=149 | |
|---|---|---|
|
Age | ||
| Median | 69 | 69 |
| Range | 48–84 | 34–92 |
| ⩽70 | 55 (59.8%) | 77 (51.7%) |
| >70 |
37 (40.2%) |
72 (48.3%) |
|
Sex | ||
| Male | 65 (70.7%) | 109 (73.2%) |
| Female |
27 (29.3%) |
40 (26.8%) |
|
ECOG PS | ||
| 0 or 1 | 84 (91.3%) | 106 (71.1%) |
| ⩾2 | 5 (5.4%) | 28 (18.8%) |
| Unknown |
3 (3.3%) |
15 (10.1%) |
|
Hb | ||
| Median (g l−1) | 135 | 125 |
| Range | 94–177 | 80–170 |
| ⩾LLN | 61 (66.3%) | 69 (46.3% |
| <LLN | 29 (31.5%) | 74 (49.7%) |
| Unknown |
2 (2.2%) |
6 (4.0%) |
|
ALP | ||
| Median (Ul−1) | 88 | 104 |
| Range | 36–342 | 38–1181 |
| ⩽ULN | 79 (85.9%) | 96 (64.4%) |
| >ULN | 9 (9.8%) | 43 (28.9%) |
| Unknown |
4 (4.3%) |
10 (6.7%) |
|
LDH | ||
| Median (IU l−1) | 429 | 439 |
| Range | 321–703 | 272–2115 |
| ⩽ULN | 21 (22.8%) | 42 (28.2%) |
| >ULN | 8 (8.7%) | 23 (15.4%) |
| Unknown |
63 (68.5%) |
84 (56.4%) |
|
Grade | ||
| 2 | 10 (10.9%) | 14 (9.4%) |
| 3 | 81 (88.0%) | 122 (81.9%) |
| Unknown |
1 (1.1%) |
13 (8.7%) |
|
Primary tumour site | ||
| Bladder | 92 (100%) | 111 (74.5%) |
| Renal pelvis | — | 22 (14.8%) |
| Ureteric | — | 13 (8.7%) |
| Urethral |
— |
3 (2.0%) |
|
T stage | ||
| ⩽2 | 44 (47.8%) | 40 (26.8% |
| 3 | 35 (38.0%) | 48 (32.2%) |
| 4 | 13 (14.1%) | 16 (10.7%) |
| X |
0 |
43 (28.9%) |
|
N stage | ||
| 0 | 92 (100%) | 70 (47.0%) |
| 1 | — | 24 (16.1%) |
| 2 | — | 54 (36.2%) |
| 3 |
— |
1 (0.7%) |
|
M stage | ||
| 0 | 92 (100%) | 62 (41.6%) |
| 1 |
— |
87 (58.4%) |
|
Visceral metastases | ||
| No | — | 95 (63.8%) |
| Yes |
— |
54 (36.2%) |
|
Bajorin risk factors (Bajorin et al, 1999) | ||
| 0 | — | 70 (47.0%) |
| 1 | — | 47 (31.5%) |
| 2 | — | 17 (11.4%) |
| Unknown |
— |
15 (10%) |
|
Chemotherapy regimen | ||
| GC | 83 (90.2%) | 76 (51.0%) |
| GCarbo | 9 (9.8%) | 50 (33.6%) |
| Other |
0 |
23 (15.4%) |
|
Prior chemotherapy | ||
| No | — | 127 (85.2%) |
| Yes |
— |
22 (14.8%) |
|
Radical local therapy | ||
| Surgery | 48 (52.2%) | 10 (3.4%) |
| Radiotherapy | 28 (30.4%) | 5 (6.7) |
| None | 14 (15.2%) | 134 (89.9%) |
| Unknown |
2 (2.2%) |
0 |
|
hCGβ
level before chemotherapy | ||
| <2 IU l−1 | 58 (63.0%) | 61 (40.9%) |
| ⩾2 IU l−1 | 27 (29.3%) | 77 (51.7%) |
| Unknown |
7 (7.6%) |
11 (7.4%) |
|
hCGβ
level on completion of chemotherapy | ||
| <2 IU l−1 | 28 (30.4%) | 56 (37.6%) |
| ⩾2 IU l−1 | 5 (5.4%) | 40 (26.8%) |
| Unknown | 59 (64.1%) | 53 (35.6%) |
Abbreviations: ALP=alkaline phosphatase; ECOG PS=Eastern Cooperative Oncology Group performance status; GC=gemcitabine/cisplatin; GCarbo=gemcitabine/carboplatin; Hb=haemoglobin; LDH=lactate dehydrogenase; LLN=lower limit of normal for the treating institution's reference range; ULN=upper limit of normal for the treating institution's reference range.