Table 1. Baseline characteristicsa.
| |
Axitinib |
Sorafenib |
|---|---|---|
| Variable | n=361 | n=362 |
| Age, years, median (range) |
61 (20–82) |
61 (22–80) |
|
Gender | ||
| Male | 265 (73) | 258 (71) |
| Female |
96 (27) |
104 (29) |
|
Race | ||
| White | 278 (77) | 269 (74) |
| Black | 1 (<1) | 4 (1) |
| Asian | 77 (21) | 81 (22) |
| Other |
5 (1) |
8 (2) |
|
ECOG performance status | ||
| 0 | 195 (54) | 200 (55) |
| 1 | 162 (45) | 160 (44) |
| >1 |
1 (<1)b |
0 |
|
MSKCC risk groupc (Motzer et al, 2004) | ||
| 0 (favourable) | 100 (28) | 101 (28) |
| 1–2 (intermediate) | 134 (37) | 130 (36) |
| ⩾3 (poor) | 118 (33) | 120 (33) |
| NA |
9 (2.5) |
11 (3.0) |
|
Heng
et al
risk factors (Heng et al, 2009) | ||
| 0 (favourable) | 66 (18) | 79 (22) |
| 1–2 (intermediate) | 236 (65) | 225 (62) |
| ⩾3 (poor) | 37 (10) | 34 (9) |
| N/A |
22 (6) |
24 (7) |
|
Prior systemic therapy | ||
| Sunitinib | 194 (54) | 195 (54) |
| Cytokines | 126 (35) | 125 (35) |
| Bevacizumab | 29 (8) | 30 (8) |
| Temsirolimus |
12 (3) |
12 (3) |
|
Baseline FKSI-15 score | ||
| N | 346 | 342 |
| Observed mean (s.d.) |
43.20 (8.42) |
43.34 (8.16) |
|
Baseline FKSI-DRS score | ||
| N | 346 | 341 |
| Observed mean (s.d.) | 28.87 (5.19) | 28.98 (5.19) |
Abbreviations: ECOG=Eastern Cooperative Oncology Group; FKSI=Functional Assessment of Cancer Therapy Kidney Symptom Index; FKSI-DRS=Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms; MSKCC=Memorial Sloan-Kettering Cancer Center; s.d.=standard deviation.
a
Values are n (%) unless otherwise noted.
b
Protocol violation.
c
MSKCC risk groups were derived using three risk factors: haemoglobin (⩽13 vs >13 g dl−1 for males and ⩽11.5 vs >11.5 g dl−1 for females), ‘corrected' calcium (<10 vs ⩾10 mg dl−1) and ECOG performance status (0 vs 1). Risk groups were defined as favourable (0 factors), intermediate (1 factor), or poor (2–3 factors).