Table 2.
Patient characteristics
| Characteristic | Efficacy cohort (N = 336) |
Toxicity cohort (N = 374) |
|---|---|---|
| Age | ||
| Median | 61 | 61 |
| Percentiles (25th, 75th) | 55, 69 | 54, 68 |
| BSA | ||
| Median | 1.98 | 1.96 |
| Percentiles (25th, 75th) | 1.82, 2.13 | 1.82, 2.12 |
| Race | ||
| White | 324 (96 %) | 358 (96 %) |
| Asian | 3 (0.89 %) | 3 (0.80 %) |
| Black | 5 (1.5 %) | 8 (2.1 %) |
| Arabian | 3 (0.89 %) | 4 (1.0 %) |
| Latin American | 1 (0.30 %) | 1 (0.27 %) |
| Gender | ||
| Male | 229 (68 %) | 258 (69 %) |
| Female | 107 (32 %) | 116 (31 %) |
| Clinical response | ||
| PR + CR | 143 (43 %) | 149 (40 %) |
| SD | 130 (39 %) | 149 (40 %) |
| PD | 43 (13 %) | 55 (15 %) |
| Unknown | 20 (6.0 %) | 21 (5.6 %) |
| Heng prognostic risk groupa | ||
| Good (0 risk factor) | 64 (19 %) | 68 (18 %) |
| Intermediate (1–2 risk factors) | 182 (54 %) | 197 (53 %) |
| Poor (3–6 risk factors) | 90 (27 %) | 108 (29 %) |
| Metastatic sites | ||
| 1 | 91 (27 %) | 105 (28 %) |
| 2 | 137 (41 %) | 149 (40 %) |
| ≥3 | 104 (31 %) | 116 (31 %) |
| Prior nephrectomy | ||
| No | 49 (15 %) | 63 (17 %) |
| Yes | 283 (85 %) | 307 (82 %) |
| Prior treatment | ||
| No | 254 (76 %) | 276 (74 %) |
| Yes | 82 (24 %) | 98 (26 %) |
BSA body surface area, CR complete response, PR partial response, SD stable disease, PD progressive disease
aPatients are classified according to the six Heng risk criteria: poor WHO performance status (≥2), low haemoglobin (<lower limit of normal), high calcium (>upper limit of normal) and time from initial diagnosis to treatment with sunitinib (<1 year), neutrophil count (>upper limit of normal) and thrombocytes (>upper limit of normal)