Table 2.
Demographics and baseline characteristics in Japanese versus non‐Japanese patients in the non‐randomized arm
| Japanese | Non‐Japanese | P‐value | |
|---|---|---|---|
| n = 32 | n = 59 | ||
| Age, median (range), years | 63 (43–79) | 63 (47–87) | 0.7777† |
| Sex, n (%) | |||
| Male | 19 (59) | 36 (61) | 1.0000‡ |
| Female | 13 (41) | 23 (39) | |
| Race, n (%) | |||
| White | 0 | 55 (93) | <0.0001‡ |
| Asian | 32 (100) | 1 (2) | |
| Black | 0 | 2 (3) | |
| Other | 0 | 1 (2) | |
| Height, mean (SD), cm | 161 (9) | 171 (10) | <0.0001† |
| Weight, mean (SD), kg | 61 (13) | 87 (18) | <0.0001† |
| ECOG PS, n (%)¶ | |||
| 0 | 27 (84) | 36 (61) | 0.0313‡ |
| ≥1 | 5 (16) | 23 (39) | |
| Prior nephrectomy, n (%) | |||
| Yes | 28 (88) | 53 (90) | 0.7367‡ |
| No | 4 (13) | 6 (10) | |
| Number of metastatic sites, n (%) | |||
| 1 | 13 (41) | 9 (15) | 0.0045§ |
| 2 | 10 (31) | 14 (24) | |
| 3 | 3 (9) | 18 (31) | |
| ≥4 | 6 (19) | 18 (31) | |
| Metastatic sites (lung versus lung + others), n (%) | |||
| Lung only | 7 (22) | 8 (14) | 0.3781‡ |
| Lung + others | 25 (78) | 51 (86) | |
| Metastatic sites (individual), n (%) | |||
| Lung | 20 (63) | 47 (80) | 0.0869‡ |
| Lymph node | 7 (22) | 29 (49) | 0.0137‡ |
| Kidney | 9 (28) | 10 (17) | 0.2806‡ |
| Liver | 5 (16) | 14 (24) | 0.4281‡ |
| Adrenal | 2 (6) | 15 (25) | 0.0267‡ |
| Bone | 4 (13) | 9 (15) | 1.0000‡ |
| Pancreas | 1 (3) | 2 (3) | 1.0000‡ |
| Time from histopathological diagnosis to treatment, median (range), weeks | |||
| 56 (0.1–952) | 42 (0.1–1338) | 0.8127†† | |
| Time from metastatic diagnosis to treatment, median (range), weeks | |||
| 7 (1.3–263) | 9 (1.3–325) | 0.2854†† | |
| Sum of longest diameter for target lesion, median (range), mm | |||
| 65 (11–376) | 89 (10–379) | 0.0218†† | |
| Presence of metastases (de novo) at initial diagnosis, n (%) | |||
| No | 19 (59) | 34 (58) | 1.0000‡ |
| Yes | 13 (41) | 25 (42) | |
†Using Student's t‐test. ‡Using Fisher's exact test. ¶Per case report forms and the last measure taken prior to dosing. One non‐Japanese patient had ECOG PS 2. §Using Cochran–Armitage trend exact test. ††Using Wilcoxon test. ECOG PS, Eastern Cooperative Oncology Group performance status; SD, standard deviation.