Table 1. Baseline patient characteristics.
| Characteristic | Second-line, Schedule 4/2 phase II trial (Motzer et al, 2006a) (n=63) | Second-line, Schedule 4/2 phase II trial (Motzer et al, 2006b) (n=106) | First-line, Schedule 4/2 phase III trial (Motzer et al, 2009) (n=375)a | First-line, Schedule CDD phase II trial (Barrios et al, 2012) (n=119) | Second-line, Schedule CDD phase II trial (Escudier et al, 2009) (n=107) |
|---|---|---|---|---|---|
| Median (range) age, years | 60 (24–87) | 56 (32–79) | 62 (27–87) | 58b (24–78) | 59 (29–80) |
| Male/female, n (%) | 68/32 | 63/37 | 71/29 | 76/24 | 82/18 |
|
ECOG PS, n (%) | |||||
| 0 | 34 (54) | 58 (55) | 231 (62) | 63 (53) | 61 (57) |
| 1 | 29 (46) | 48 (45) | 144 (38) | 56 (47) | 45 (42) |
| ⩾2 | 0 | 0 | 0 | 0 | 1 (1) |
|
Histology, n (%) | |||||
| Clear cell | 55 (87) | 105 (99) | 375 (100) | 119 (100) | 104 (97) |
| Other | 8 (13) | 1 (1) | 0 | 0 | 3 (3) |
| Prior nephrectomy, n (%) | 58 (92) | 106 (100) | 340 (91) | 112 (94) | 100 (93) |
| Prior cytokine therapy, n (%) | 63 (100) | 106 (100) | 0 | 0 | 107 (100) |
| Prior radiation therapy, n (%) | 25 (40) | 20 (19) | 53 (14) | 15 (13) | NA |
|
No. of disease sites, n (%) | |||||
| 1 | 8 (13) | 13 (12) | 55 (15) | 30 (25) | 12 (11) |
| ⩾2 | 55 (87) | 93 (88) | 320 (85) | 87 (73)c | 95 (89) |
Abbreviations: CDD=continuous daily dosing; ECOG PS=Eastern Cooperative Oncology Group performance status; NA=not available.
a
The 375 patients cited in the table are those who received sunitinib in this trial.
b
Mean value presented.
c
Data missing for two patients.