Table 1.
Patient Demographic and Disease Characteristics
| Characteristic | Arm A (bevacizumab alone) No. (%) | Arm B (bevacizumab plus temsirolimus) No. (%) | Arm C (bevacizumab plus sorafenib) No. (%) | Arm D (sorafenib plus temsirolimus) No. (%) | Total No. (%) |
|---|---|---|---|---|---|
| No. of patients | 84 | 80 | 83 | 84 | 331 |
| Sex | |||||
| Male | 62 (74) | 55 (69) | 57 (69) | 67 (80) | 241 (73) |
| Female | 22 (26) | 25 (31) | 26 (31) | 17 (20) | 90 (27) |
| Race | |||||
| White | 79 (95) | 69 (90) | 75 (94) | 80 (96) | 303 (94) |
| African American | 2 (2) | 5 (7) | 4 (5) | 2 (2) | 13 (4) |
| Asian | 2 (2) | 1 (1) | 0 (0) | 1 (1) | 4 (1) |
| Native American | 0 (0) | 2 (3) | 1 (1) | 0 (0) | 3 (1) |
| Unknown/missing | 1 | 3 | 3 | 1 | 8 |
| Ethnicity | |||||
| Hispanic | 1 (1) | 3 (4) | 2 (3) | 0 (0) | 6 (2) |
| Non-Hispanic | 78 (99) | 74 (96) | 78 (98) | 75 (100) | 305 (98) |
| Unknown/missing | 5 | 3 | 3 | 9 | 20 |
| Age category, years | |||||
| ≤ 50 | 8 (10) | 12 (15) | 18 (22) | 14 (17) | 52 (16) |
| 50-59 | 27 (32) | 24 (30) | 20 (24) | 32 (38) | 103 (31) |
| 60-69 | 31 (37) | 30 (38) | 34 (41) | 27 (32) | 122 (37) |
| ≥ 70 | 18 (21) | 14 (18) | 11 (13) | 11 (13) | 54 (16) |
| Histology | |||||
| Clear cell | 80 (95) | 78 (98) | 77 (83) | 77 (92) | 312 (94) |
| Mixed | 4 (5) | 2 (3) | 6 (7) | 7 (8) | 19 (6) |
| Risk category as stratified | |||||
| Favorable | 29 (35) | 30 (38) | 28 (34) | 27 (32) | 114 (34) |
| Intermediate | 31 (37) | 27 (34) | 35 (42) | 32 (38) | 125 (38) |
| Poor | 24 (29) | 23 (29) | 20 (24) | 25 (30) | 92 (28) |
| Risk category | |||||
| Favorable | 26 (31) | 27 (34) | 25 (30) | 31 (37) | 109 (33) |
| Intermediate | 34 (41) | 31 (39) | 37 (45) | 31 (37) | 133 (40) |
| Poor | 24 (29) | 22 (28) | 21 (25) | 22 (26) | 89 (27) |
| Primary tumor ≤ 5 cm* | |||||
| No | 6 (55) | 7 (78) | 3 (38) | 7 (64) | 23 (59) |
| Yes | 5 (46) | 2 (22) | 5 (63) | 4 (36) | 16 (41) |
| Extensive liver involvement* | |||||
| No | 6 (55) | 8 (89) | 5 (63) | 8 (73) | 27 (69) |
| Yes | 5 (46) | 1 (11) | 3 (38) | 3 (27) | 12 (31) |
| Multiple (> five) bone metastases* | |||||
| No | 9 (82) | 7 (78) | 7 (88) | 7 (64) | 30 (77) |
| Yes | 2 (18) | 2 (22) | 1 (13) | 4 (36) | 9 (23) |
| T stage | |||||
| 0 | 2 (3) | 0 (0) | 0 (0) | 0 (0) | 2 (1) |
| 1A | 4 (5) | 5 (6) | 5 (6) | 1 (1) | 15 (5) |
| 1B | 7 (9) | 8 (10) | 11 (13) | 10 (12) | 36 (11) |
| 2 | 16 (20) | 16 (21) | 16 (20) | 19 (24) | 67 (21) |
| 3 | 1 (1) | 1 (1) | 0 (0) | 0 (0) | 2 (1) |
| 3A | 17 (21) | 24 (31) | 18 (22) | 19 (24) | 78 (24) |
| 3B | 20 (25) | 17 (22) | 21 (26) | 25 (31) | 83 (26) |
| 3C | 1 (1) | 1 (1) | 3 (4) | 1 (1) | 6 (2) |
| 4 | 11 (14) | 4 (5) | 3 (4) | 2 (3) | 20 (6) |
| X | 1 (1) | 2 (3) | 5 (6) | 4 (5) | 12 (4) |
| Unknown/missing | 4 | 2 | 1 | 3 | 10 |
| N stage | |||||
| 0 | 35 (46) | 34 (44) | 28 (36) | 30 (38) | 127 (41) |
| 1 | 5 (7) | 5 (6) | 4 (5) | 9 (11) | 23 (7) |
| 2 | 8 (10) | 9 (12) | 12 (16) | 9 (11) | 38 (12) |
| X | 29 (38) | 30 (39) | 33 (43) | 31 (39) | 123 (40) |
| Unknown/missing | 7 | 2 | 6 | 5 | 20 |
| M stage | |||||
| 0 | 27 (34) | 20 (25) | 24 (30) | 25 (31) | 96 (30) |
| 1 | 35 (44) | 37 (47) | 35 (43) | 40 (49) | 147 (46) |
| X | 17 (22) | 22 (28) | 22 (28) | 17 (21) | 78 (24) |
| Unknown/missing | 5 | 1 | 2 | 2 | 10 |
*
Among patients with no prior nephrectomy.