Table 4.
Baseline characteristics and efficacy of AVAGAST and AVATAR by region (intent to treat populations)
| AVAGAST study | AVATAR study | ToGA study | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Asia | Europe | Pan-America | China | China subgroup | ||||||
| BEV (n = 188) |
Placebo (n = 188) |
BEV (n = 125) |
Placebo (n = 124) |
BEV (n = 74) |
Placebo (n = 75) |
BEV (n = 100) |
Placebo (n = 102) |
Trastuzumab (n = 36) |
Placebo (n = 48) |
|
| Male (%) | 68 | 67 | 66 | 67 | 64 | 65 | 68 | 73 | 78 | 81 |
| Median age (years) | 58.5 | 59.0 | 59.0 | 59.0 | 53.5 | 56.0 | 56 | 59 | 58.7 | 58.2 |
| ECOG PS (%) | ||||||||||
| 0/1 | 98 | 95 | 89 | 93 | 95 | 97 | 95 | 95 | 81 | 81 |
| 2 | 2 | 5 | 11 | 7 | 5 | 3 | 5 | 5 | 19 | 19 |
| Primary tumor site GEJ (%) | 7 | 5 | 23 | 22 | 15 | 17 | 15 | 20 | 19 | 21 |
| Measurable disease (%) | 76 | 70 | 87 | 89 | 81 | 73 | 81 | 84 | 89 | 90 |
| Liver metastases (%) | 29 | 26 | 35 | 38 | 42 | 41 | 39 | 39 | 53* | 44a |
| Prior gastrectomy (%) | 32 | 31 | 22 | 25 | 31 | 23 | 24 | 20 | 14 | 6 |
| Further treatment (%) | 59 | 67 | 24 | 29 | 24 | 15 | 11 | 15 | 11 | 10 |
| Median overall survival (months) | 13.9 | 12.1 | 11.1 | 8.6 | 11.5 | 6.8 | 10.5 | 11.4 | 12.6 | 9.7 |
| HR (95 % CI) | 0.97 (0.75–1.25) | 0.85 (0.63–1.14) | 0.63 (0.43–0.94) | 1.11 (0.79–1.56) | 0.72 (0.40–1.29) | |||||
| Median progression-free survival (months) | 6.7 | 5.6 | 6.9 | 4.4 | 5.9 | 4.4 | 6.3 | 6.0 | 6.8 | 5.5 |
| HR (95 % CI) | 0.92 (0.74–1.14) | 0.71 (0.54–0.93) | 0.65 (0.46–0.93) | 0.89 (0.66–1.21) | 0.69 (0.41–1.15) | |||||
| ORR (%) | 47.9 | 45.5 | 41.3 | 28.2 | 50.0 | 36.4 | 40.7 | 33.7 | 36.1 | 33.3 |
| OR (95 % CI) | 1.10 (0.69–1.77) | 1.79 (1.02–3.15) | 1.75 (0.83–3.69) | 1.19 (0.65–2.20) | 1.13 (0.46–2.80) | |||||
BEV bevacizumab, CI confidence interval, ECOG Eastern Cooperative Oncology Group, GEJ gastroesophageal junction, HR hazard ratio, ORR overall response rate, OR odds ratio, PS performance status
aOrgan (lung or liver) with metastases