Table 1.
Summary of efficacy in phase II and III studies of bevacizumab in advanced gastric and gastroesophageal junction cancer
| Author | Trial design/Setting | No. of patients | Treatment | Primary endpoint | OS | PFS/TTP | ORR |
|---|---|---|---|---|---|---|---|
| Shah et al. [13] | Phase II, single-arm/1st-line | 44 | Bevacizumab+docetaxel/cisplatin/5-FU | PFS | 16.8 mo | 12 mo | 67% |
| 95% CI 12.1-26.1 | 95% CI 8.8-18.2 | 95% CI 50-81 | |||||
| Shah et al. [14] | Phase II, single-arm/1st-line | 47 | Bevacizumab+cisplatin/irinotecan | TTP | 12.3 mo | NR | 65% |
| 95% CI 11.3-17.2 | 95% CI 46-80 | ||||||
| Enzinger et al. [15] | Phase II, single-arm/1st- and 2nd-line | 35 | Bevacizumab+docetaxel/cisplatin/irinotecan | ORR | 26.9 mo | 13.9 mo | 77% |
| 95% CI 11.31-36.36 | 95% CI 8.5-22.33 | 95% CI 0.59-0.88 | |||||
| El-Rayes et al. [16] | Phase II, single-arm/1st-line | 38 | Bevacizumab+docetaxel/oxaliplatin | PFS | 11.1 mo | 6.6 mo | 42% |
| 95% CI 8.2-15.3 | 95% CI 4.4-10.5 | 95% CI 28-58 | |||||
| Uronis et al. [17] | Phase II, single-arm/1st-line | 37 | Bevacizumab+capecitabine/oxaliplatin | PFS | 10.8 mo | 7.2 mo | 51% |
| 95% CI 8.7-14.5 | 95% CI 5.4-8.5 | 95% CI 35.5-67.1 | |||||
| Ohstu et al. (AVAGAST) [18] | Phase III, randomized, double-blind, placebo-controlled/1st-line | 774 | Bevacizumab+fluoropyrimidine/cisplatin vs. placebo+fluoropyrimidine/cisplatin | OS | Bevacizumab+fluoropyrimidine/cisplatin 12.1 mo vs. placebo+fluoropyrimidine/cisplatin 10.1 mo: | Bevacizumab+fluoropyrimidine/cisplatin 6.7 mo vs. placebo+fluoropyrimidine/cisplatin 5.3 mo: | Bevacizumab+fluoropyrimidine/cisplatin 46% vs. placebo+fluoropyrimidine/cisplatin 37%: |
| HR 0.87 | HR 0.80 | p=0.0315 | |||||
| 95% CI 0.73-1.03 | 95% CI 0.68-0.93 | ||||||
| p=0.1002 | p=0.0037 | ||||||
| Shen et al. (AVATAR) [19] | Phase III, randomized, double-blind, placebo-controlled/1st-line | 202 | Bevacizumab+capecitabine/cisplatin vs. placebo+capecitabine/cisplatin | OS | Bevacizumab+capecitabine/cisplatin 10.5 mo vs. placebo+capecitabine/cisplatin 11.4 mo: | Bevacizumab+capecitabine/cisplatin 6.3 mo vs. placebo+capecitabine/cisplatin 6.0 mo: | Bevacizumab+capecitabine/cisplatin 41% vs. placebo+capecitabine/cisplatin 34%: |
| HR 1.11 | HR 0.89 | p=0.3480 | |||||
| 95% CI 0.79-1.56 | 95% CI 0.66-1.21 | ||||||
| p=0.5567 | p=0.4709 | ||||||
| Cunningham et al. (ST03) [20] | Phase II/III, randomized, open-label, placebo-controlled/1st-line | 1,063 | Bevacizumab+epirubicin/capecitabine/cisplatin vs. placebo+epirubicin/capecitabine/cisplatin | OS | HR 1.067 | HR 1.026 | Bevacizumab+ECX 30% vs. placebo+ECX 32% |
| 95% CI 0.891-1.280 | 95% CI 0.867-1.214 | ||||||
| p=0.478 | p=0.768 |
OS, overall survival (median); PFS, progression-free survival (median); TTP, time to progression (median); ORR, objective response rate; 5-FU, 5-fluorouracil; CI, confidence interval; NR, not reported; HR, hazard ratio; ECX, epirubicin, cisplatin, and capecitabine.