Table 1.
Baseline characteristics by region (placebo plus chemotherapy arm)
| Characteristic | USA/western Europe (n = 81) | Eastern Europe/South America (n = 118) | Korea and other Asia (n = 94) | Japan (n = 94) | |
|---|---|---|---|---|---|
| Sex | Male | 52 (64) | 80 (68) | 63 (67) | 63 (67) |
| Female | 29 (36) | 38 (32) | 31 (33) | 31 (33) | |
| Age (years) | < 65 | 49 (60) | 92 (78) | 75 (80) | 62 (66) |
| ≥ 65 | 32 (40) | 26 (22) | 19 (20) | 32 (34) | |
| ECOG performance status | 0 | 42 (52) | 28 (24) | 36 (38) | 62 (66) |
| ≥ 1 | 39 (48) | 90 (76) | 58 (62) | 32 (34) | |
| Primary site | Stomach | 52 (64) | 107 (91) | 91 (97) | 88 (94) |
| Gastroesophageal junction | 29 (36) | 11 (9) | 3 (3) | 6 (6) | |
| Disease status | Locally advanced | 4 (5) | 4 (3) | 0 | 1 (1) |
| Metastatic | 77 (95) | 114 (97) | 94 (100) | 93 (99) | |
| Liver metastasis | Yes | 27 (34) | 51 (43) | 25 (27) | 23 (24) |
| No | 53 (66) | 67 (57) | 69 (73) | 71 (76) | |
| Number of metastatic sites | > 1 | 45 (57) | 80 (70) | 63 (67) | 59 (63) |
| ≤ 1 | 34 (43) | 35 (30) | 31 (33) | 35 (37) | |
| Histological typea | Intestinal | 39 (48) | 46 (39) | 28 (30) | 22 (23) |
| Diffuse/mixed | 40 (49) | 68 (58) | 52 (55) | 72 (77) | |
| Prior gastrectomy | Yes | 16 (20) | 32 (27) | 28 (30) | 31 (33) |
| No | 65 (80) | 86 (73) | 66 (70) | 63 (67) | |
| Prior (neo)adjuvant chemotherapy | Yes | 9 (11) | 3 (3) | 10 (11) | 8 (9) |
| No | 72 (89) | 115 (97) | 84 (89) | 86 (91) | |
| Disease measurability (tumor size)b | Not measurable | 16 (20) | 18 (15) | 27 (29) | 29 (31) |
| Measurable (< 40 mm) | 39 (49) | 47 (40) | 48 (51) | 47 (50) | |
| Measurable (≥ 40 mm) | 25 (31) | 53 (45) | 19 (20) | 18 (19) | |
| Peritoneal metastasis | Yes | 24 (30) | 47 (40) | 49 (52) | 52 (55) |
| No | 57 (70) | 71 (60) | 45 (48) | 42 (45) | |
| Bone metastasis | Present | 4 (5) | 4 (3) | 3 (3) | 5 (5) |
| Not present | 76 (95) | 114 (97) | 91 (97) | 89 (95) | |
Data are expressed as n (%)
ECOG Eastern Cooperative Oncology Group
aPatients with unknown histological type are excluded
bOne patient from USA/western Europe had a measurable tumour of unknown size