Table 1. Baseline demographics and disease characteristics.
| Dovitinib (n = 284) | Sorafenib (n = 286) | |
|---|---|---|
| Age, years, median (range) | 61 (29–89) | 62 (18–81) |
| Age ≥ 65 years, n (%) | 97 (34) | 121 (42) |
| Sex, n (%) | ||
| Male | 213 (75) | 219 (77) |
| Female | 71 (25) | 67 (23) |
| Race, n (%) | ||
| White | 233 (82) | 232 (81) |
| Asian | 42 (15) | 40 (14) |
| Black | 3 (1) | 5 (2) |
| Other/unknown | 6 (2) | 9 (3) |
| Region, n (%) | ||
| Europe and Middle East | 171 (60) | 170 (59) |
| America | 66 (23) | 67 (23) |
| Asia (excluding Japan) | 28 (10) | 28 (10) |
| Japan | 19 (7) | 21 (7) |
| Karnofsky performance score, n (%) | ||
| 100 | 83 (29) | 73 (26) |
| 90 | 93 (33) | 101 (35) |
| 80 | 73 (26) | 83 (29) |
| 70 | 35 (12) | 29 (10) |
| MSKCC risk group, n (%)21 | ||
| Favorable | 58 (20) | 59 (21) |
| Intermediate | 164 (58) | 162 (57) |
| Poor | 62 (22) | 65 (23) |
| Metastatic site of cancer, n (%) | ||
| Lung | 224 (79) | 216 (76) |
| Lymph nodes | 144 (51) | 147 (51) |
| Bone | 99 (35) | 119 (42) |
| Liver | 94 (33) | 94 (33) |
| Prior therapy, n (%) | ||
| Prior nephrectomy | 272 (96) | 260 (91) |
| Radiotherapy | 66 (23) | 91 (32) |
| Cytokines | 20 (7) | 23 (8) |
| Targeted therapy | ||
| VEGF targeted | 284 (100) | 286 (100) |
| Sunitinib | 260 (92) | 253 (88) |
| Bevacizumab | 10 (4) | 11 (4) |
| Axitinib | 3 (1) | 6 (2) |
| Pazopanib | 10 (4) | 11 (4) |
| Other investigational agent | 1 (< 1) | 5 (2) |
| mTOR inhibitor | 284 (100) | 286 (100) |
| Everolimus | 247 (87) | 247 (86) |
| Temsirolimus | 35 (12) | 39 (14) |
| Other investigational agent | 2 (1) | 0 |
| Number of prior treatment regimens, n (%) | ||
| 2 | 264 (93) | 259 (91) |
| 3 | 16 (6) | 25 (9) |
| ≥ 4 | 4 (1) | 2 (1) |
| Best response to last VEGF-targeted agent, n (%) | ||
| Complete response | 7 (2) | 5 (2) |
| Partial response | 76 (27) | 72 (25) |
| Stable disease | 121 (43) | 120 (42) |
| Disease progression | 50 (18) | 42 (15) |
| Unknown/not applicable | 29 (10) | 42 (15) |
| Best response to last mTOR inhibitor, n (%) | ||
| Complete response | 0 | 1 (< 1) |
| Partial response | 19 (7) | 18 (6) |
| Stable disease | 123 (43) | 105 (37) |
| Disease progression | 108 (38) | 116 (41) |
| Unknown/not applicable | 32 (11) | 46 (16) |
MSKCC, Memorial Sloan-Kettering Cancer Center; mTOR, mammalian target of rapamycin; VEGF, vascular endothelial growth factor.