Table 1.
Patient demographics and baseline clinical characteristics in Japanese vs. non-Japanese patients
| Japanese n = 44 | Non-Japanese n = 169 | P value | |
|---|---|---|---|
| Age, median (range), years | 66 (42–81) | 61 (28–87) | 0.0231a |
| Sex, n (%) | |||
| Male | 30 (68) | 113 (67) | 1.0000b |
| Female | 14 (32) | 56 (33) | |
| Race, n (%) | |||
| White | 0 | 162 (96) | <0.0001b |
| Asian | 44 (100) | 2 (1) | |
| Black | 0 | 2 (1) | |
| Other | 0 | 3 (2) | |
| Height, mean (SD), cm | 162 (9) | 172 (10) | <0.0001a |
| Weight, mean (SD), kg | 61 (12) | 83 (18) | <0.0001a |
| ECOG PS, n (%)c | |||
| 0 | 37 (84) | 99 (59) | 0.0015b |
| ≥1 | 7 (16) | 70 (41) | |
| Prior nephrectomy, n (%) | |||
| Yes | 37 (84) | 146 (86) | 0.8077b |
| No | 7 (16) | 23 (14) | |
| No. of metastatic sites, n (%) | |||
| 1 | 17 (39) | 24 (14) | 0.0003d |
| 2 | 13 (30) | 44 (26) | |
| 3 | 6 (14) | 46 (27) | |
| ≥4 | 8 (18) | 55 (33) | |
| Metastatic sites (lung vs. lung + others), n (%) | |||
| Lung only | 9 (20) | 16 (9) | 0.0627b |
| Lung + others | 35 (80) | 153 (91) | |
| Metastatic sites (individual), n (%) | |||
| Lung | 30 (68) | 119 (70) | 0.8538b |
| Lymph node | 13 (30) | 86 (51) | 0.0169b |
| Kidney | 13 (30) | 37 (22) | 0.3194b |
| Liver | 6 (14) | 47 (28) | 0.0766b |
| Adrenal | 3 (7) | 46 (27) | 0.0042b |
| Bone | 7 (16) | 30 (18) | 1.0000b |
| Pancreas | 1 (2) | 4 (2) | 1.0000b |
| Time from histopathological diagnosis to treatment, median (range), weeks | 56 (0.1–952) | 23 (0.1–1338) | 0.9223e |
| Time from metastatic diagnosis to treatment, median (range), weeks | 7 (0.9–263) | 8 (0.7–456) | 0.4476e |
| Sum of longest diameter for target lesion, median (range), mm | 75 (10–376) | 99 (10–466) | 0.0013e |
| Presence of metastases (de novo) at initial diagnosis, n (%) | |||
| No | 25 (57) | 94 (56) | 1.0000b |
| Yes | 19 (43) | 75 (44) | |
ECOG PS, Eastern Cooperative Oncology Group performance status; SD, standard deviation.
aUsing t-test.
bUsing Fisher's exact test.
cPer case report forms and the last measure taken prior to dosing. One non-Japanese patient had ECOG PS 2.
dUsing Cochran-Armitage trend exact test.
eUsing Wilcoxon test.