Table 1.
Patient demographics and baseline characteristics
| n (%)a | Axitinib |
Placebo |
||
|---|---|---|---|---|
| Asian n = 262 | Non-Asian n = 101 | Asian n = 264 | Non-Asian n = 97 | |
| Age, years | ||||
| <65 | 188 (71.7) | 67 (66.3) | 177 (67.0) | 70 (72.2) |
| ≥65 | 74 (28.2) | 34 (33.7) | 87 (33.0) | 27 (27.8) |
| Mean (SD) | 58.1 (10.38) | 57.4 (11.84) | 58.5 (11.70) | 57.1 (10.27) |
| Median (range) | 58.0 (25-82) | 60.0 (21-84) | 59.0 (21-85) | 56.0 (31-79) |
| Sex | ||||
| Male | 201 (76.7) | 79 (78.2) | 179 (67.8) | 71 (73.2) |
| Female | 61 (23.3) | 22 (21.8) | 85 (32.2) | 26 (26.8) |
| Race | ||||
| Asianb | 262 (100) | 2 (2.0) | 264 (100) | 3 (3.1) |
| White | — | 91 (90.1) | — | 90 (92.8) |
| Black | — | 3 (2.8) | — | 1 (1.0) |
| Other | — | 5 (5.0) | — | 3 (3.1) |
| Body mass index, kg/m2 | ||||
| Normal weight (≥18.5, <25) | 168 (64.1) | 19 (18.9) | 154 (58.3) | 19 (19.6) |
| Overweight (≥25, <30) | 74 (28.2) | 41 (40.6) | 87 (33.0) | 37 (38.1) |
| Obese (≥30) | 12 (4.6) | 38 (37.6) | 11 (4.2) | 40 (41.2) |
| Underweight (<18.5) | 6 (2.3) | 1 (1.0) | 12 (4.5) | — |
| Duration since histopathic diagnosis | ||||
| Mean (SD) | 8.57 (1.92) | 10.92 (7.32) | 8.51 (2.06) | 9.75 (2.00) |
| Median (range) | 8.7 (4.0-16.3) | 10.3 (4.1-79.3) | 8.6 (3.3-16.0) | 10.0 (3.9-13.6) |
| Body site of disease at diagnosis | ||||
| Right kidney | 125 (47.7) | 58 (57.4) | 132 (50.0) | 49 (50.5) |
| Left kidney | 137 (52.3) | 43 (42.6) | 130 (49.2) | 48 (49.5) |
| Both kidneys | — | — | 2 (0.8) | — |
| Fuhrman grade | ||||
| 1 | 9 (3.4) | 1 (1.0) | 13 (4.9) | 3 (3.1) |
| 2 | 87 (33.2) | 27 (26.7) | 91 (34.4) | 31 (32.0) |
| 3 | 114 (43.5) | 48 (47.5) | 105 (39.8) | 35 (36.1) |
| 4 | 42 (16.0) | 25 (24.8) | 39 (14.8) | 28 (28.9) |
| Missing | 10 (3.8) | — | 16 (6.1) | — |
| Risk group,cn (%) | ||||
| (a) pT2, pN0 or pNx, M0 and ECOG PS 0-1 | 39 (14.9) | 4 (4.0) | 36 (13.6) | 1 (1.0) |
| (b) pT3, pN0 or pNx, M0 and ECOG PS 0-1 | 205 (78.2) | 91 (90.1) | 206 (78.0) | 91 (93.8) |
| (c) pT4, pN0 or pNx, M0 and ECOG PS 0-1 | 5 (1.9) | 2 (2.0) | 7 (2.7) | 1 (1.0) |
| (d) Any pT, pN1, M0 and ECOG PS 0-1 | 13 (5.0) | 4 (4.0) | 15 (5.7) | 4 (4.1) |
| Highest risk (b with Fuhrman grade 3 or 4) + c + d | 136 (51.9) | 73 (72.3) | 136 (51.5) | 64 (66.0) |
| Lower risk [a + (b with Fuhrman grade 1 or 2)] | 118 (45.0) | 28 (27.7) | 116 (43.9) | 33 (34.0) |
ECOG PS, Eastern Cooperative Oncology Group performance score; M0, no spread of tumour to distant lymph nodes or other organs; SD, standard deviation; TNM, tumour, nodes, and metastasis.
a
Unless otherwise indicated.
b
Patient classification of Asian is based on country of enrolment.
c
TNM staging. pT2, primary tumour stage 2; pN0, primary tumour has not spread to lymph nodes; pNx, regional lymph nodes cannot be assessed; pT3, primary tumour stage 3; pT4, primary tumour stage 4; pN1, primary tumour has spread to nearby lymph nodes.