Table 1.
Baseline characteristics in the biomarker subset and the intent-to-treat population, by treatment arm
| Biomarker subset (N = 63) |
Intent-to-treat population (N = 750) |
|||
|---|---|---|---|---|
| Sunitinib (N = 33) |
IFN-α (N = 30) |
Sunitinib (N = 375) |
IFN-α (N = 375) |
|
| Gender, n (%) | ||||
| Male | 21 (64) | 24 (80) | 267 (71) | 269 (72) |
| Female | 12 (36) | 6 (20) | 108 (29) | 106 (28) |
| Race, n (%) | ||||
| White | 32 (97) | 25 (83) | 354 (94) | 340 (91) |
| Black | 0 | 1 (3) | 4 (1) | 9 (2) |
| Asian | 1 (3) | 2 (7) | 7 (2) | 12 (3) |
| Not listed | 0 | 2 (7) | 9 (2) | 13 (3) |
| Not allowed to aska | 0 | 0 | 1 (<1) | 1 (<1) |
| Median age (range), years | 64 (40–87) | 62 (42–85) | 62 (27–87) | 59 (34–85) |
| ECOG performance status, n (%) | ||||
| 0 | 25 (76) | 20 (67) | 231 (62) | 229 (61) |
| 1 | 8 (24) | 10 (33) | 144 (38) | 146 (39) |
| Prior nephrectomy, n (%) | 29 (88) | 27 (90) | 337 (90) | 336 (90) |
| Sites of metastasis, n (%) | ||||
| Lung | 26 (79) | 24 (80) | 292 (78) | 297 (79) |
| Liver | 10 (30) | 12 (40) | 99 (26) | 90 (24) |
| Bone | 5 (15) | 7 (23) | 113 (30) | 112 (30) |
| Lymph node | 20 (61) | 16 (53) | 218 (58) | 198 (53) |
| Number of disease sites, n (%) | ||||
| 1 | 6 (18) | 9 (30) | 54 (14) | 73 (19) |
| 2 | 12 (36) | 8 (27) | 107 (29) | 111 (30) |
| ≥3 | 15 (45) | 13 (43) | 214 (57) | 191 (51) |
| Risk factors based on published MSKCC data,b n (%) | ||||
| 0 (favorable) | 11 (33) | 12 (41) | 143 (38) | 121 (34) |
| 1–2 (intermediate) | 22 (67) | 17 (59) | 209 (56) | 212 (59) |
| ≥3 (poor) | 0 | 0 | 23 (6) | 25 (7) |
ECOG Eastern Cooperative Oncology Group, IFN-α interferon-alpha, MSKCC Memorial Sloan-Kettering Cancer Center
aBy local regulation
bData were missing for 17 patients in the IFN-α group (including one patient in the biomarker subset). Includes low serum hemoglobin level; elevated corrected serum calcium level; elevated serum lactate dehydrogenase level; poor performance status; and interval of <1 year between diagnosis and treatment [8]