Table 1.
Demographics and baseline characteristics
| Rilotumumab plus epirubicin, cisplatin, and capecitabine (n=304) |
Placebo plus epirubicin, cisplatin, and capecitabine (n=305) |
|
|---|---|---|
| Age (years) | 61 (28–84) | 59 (26–81) |
| >65 years | 111 (37%) | 94 (31%) |
|
| ||
| Sex | ||
| Male | 205 (67%) | 220 (72%) |
| Female | 99 (33%) | 85 (28%) |
|
| ||
| Ethnicity | ||
| Hispanic or Latino | 23 (8%) | 24 (8%) |
| Other | 281 (92%) | 281 (92%) |
|
| ||
| Race | ||
| White | 290 (95%) | 288 (94%) |
| Asian | 4 (1%) | 2 (<1%) |
| Black or African American | 3 (1%) | 5 (2%) |
| Native Hawaiian or other Pacific Islander | 1 (<1%) | 0 |
| Other | 6 (2%) | 10 (3%) |
|
| ||
| Region | ||
| Western Europe, South Africa, Australia | 121 (40%) | 129 (42%) |
| Eastern Europe (including Turkey) | 141 (46%) | 130 (43%) |
| North America | 26 (9%) | 27 (9%) |
| South America | 16 (5%) | 19 (6%) |
|
| ||
| ECOG performance score | ||
| 0 | 117 (39%) | 115 (38%) |
| 1 | 187 (62%) | 189 (62%) |
| 2 | 0 | 1 (<1%)* |
|
| ||
| Primary tumour location | ||
| Distal oesophageal | 24 (8%) | 39 (13%) |
| Gastro-oesophageal junction | 53 (17%) | 71 (23%) |
| Gastric | 227 (75%) | 195 (64%) |
|
| ||
| Histological type (WHO classification) | ||
| Tubular adenocarcinoma | 22 (7%) | 22 (7%) |
| Mucinous adenocarcinoma | 8 (3%) | 11 (4%) |
| Papillary adenocarcinoma | 2 (<1%) | 1 (<1%) |
| Signet-ring carcinoma | 36 (12%) | 36 (12%) |
| Adenocarcinoma | 236 (78%) | 235 (77%) |
|
| ||
| Metastatic disease | 284 (93%) | 283 (93%) |
|
| ||
| Liver metastases | 118 (39%) | 136 (45%) |
|
| ||
| Disease stage at initial diagnosis | ||
| I | 11 (4%) | 3 (1%) |
| II | 18 (6%) | 17 (6%) |
| III | 42 (14%) | 42 (14%) |
| IV | 230 (76%) | 240 (79%) |
| Missing | 3 (1%) | 3 (1%) |
|
| ||
| Previous surgery† | 48 (16%) | 48 (16%) |
|
| ||
| Previous chemotherapy‡ | 24 (8%) | 31 (10%) |
|
| ||
| Previous radiotherapy | 15 (5%) | 27 (9%) |
|
| ||
| H score§ | 96 (56) | 93 (56) |
Data are median (range), n (%), or mean (SD). ECOG=Eastern Cooperative Oncology Group.
*
This patient was enrolled in error.
†
Surgery included previous gastrectomy or oesophagectomy.
‡
Chemotherapy included previous adjuvant or neoadjuvant chemotherapy.
§
Histology score (calculated as 1×[% cells 1+] + 2×[% cells 2+]+ 3×[% cells 3+]). The biomarker analyses only included patients who had received at least one dose of study treatment and had evaluable biomarker data (rilotumumab, n=298; placebo, n=299; overall, n=597).