Table 2.
Main first-line bevacizumab trials results.
| Trial (phase) | Line | Treatment arms (n.) | Primary endpoint | PFS | OS | ORR (%) |
|---|---|---|---|---|---|---|
| AVF2107g (III) [26] | 1st | ILF + bevacizumab (n.402) ILF + placebo (n.411) |
OS | 10.6 m 6.2 m [HR 0.54; p < 0.001]* |
20.3 m 15.6 m [HR 0.66; p < 0.001]* |
44.8 34.8 [p = 0.004] |
| BICC-C (III) | 1st | FOLFIRI + bevacizumab (n.57) FOLFIRI (n.60) |
PFS | 11.2 m 8.3 m [p = 0.28]** |
28.0 m 19.2 m [p = 0.037]** |
57.9 53.3 *** |
| NO16966 (III) [27] | 1st | XELOX + bevacizumab (n.350) FOLFOX4 + bevacizumab (n.349) XELOX + placebo (n.350) FOLFOX4 + placebo (n.351) |
PFS | 9.4 m 8.0 m [HR 0.83; 95% CI, 0.72–0.95; p = 0.0023] |
21.3 m 19.9 m [HR 0.89; 95% CI, 0.76–1.03; p = 0.0769] |
47 49 [p = 0.31] |
| TRIBE (III) [29,30] | 1st | FOLFOXIRI + bevacizumab (n.57) FOLFIRI + bevacizumab (n.57) |
PFS | 12.1 m 9.7 m [HR 0.75; 95% CI, 0.62–0.90; p = 0.003] |
31.0 m 21.8 m [HR 0.79; 95% CI, 0.63–1.00; p = 0.054] |
65 53 [p = 0.006] |
| AVEX (III) [35] | 1st | Capecitabine + bevacizumab (n.140) capecitabine (n.140) |
PFS | 9.1 m 5.1 m [HR 0.53; 95% CI, 0.41–0.69; p < 0.0001] |
20.7 m 16.8 m [HR 0.79; 95% CI, 0.57–1.09; p = 0.18] |
19 10 [p = 0.04] |
| CAIRO-3 (III) NCT00442637 [36] | 1st | Capecitabine + bevacizumab manteinance (n.279) observation (n.278) |
PFS2 | 11.7 m 8.5 m [HR 0.63; 95% CI, 0.53–0.77; p < 0.0001] |
21.6 m 18.1 m [HR 0.83; 95% CI, 0.68–1.01; p = 0.06] |
Not evaluated |
| FIRE-3 (III) NCT00433927 [38] | 1st | FOLFIRI + bevacizumab (n.295) FOLFIRI + cetuximab (n.297) |
ORR | 10.3 m 10.0 m [HR 1.06; 95% CI, 0.88–1.26; p = 0.55] |
25.0 m 28.7 m [HR 0.77; 95% CI, 0.62–0.96; p = 0.017] |
58 62 [p < 0.18] |
| PEAK (III) NCT00819780 [40] | 1st | FOLFOX + Bevacizumab (n.143) FOLFOX + Panitumumab (n.142) |
PFS | 10.1 m 10.9 m [HR 0.87; 95% CI, 0.65–1.17; p = 0.35] |
24.3 m 34.2 m [HR 0.62; 95% CI, 0.44–0.89; p = 0.009] |
53.5 57.8 *** |
| CALGB/SWOG 80,405 (III) NCT00265850 [41,42] | 1st | FOLFIRI/FOLFOX6 + bevacizumab (n.559) FOLFIRI/FOLFOX6 + cetuximumab (n.578) |
OS | 10.6 m 10.5 m [HR 0.95; 95% CI, 0.84 to 1.08; p = 0.45] |
29.0 m 30.0 m [HR 0.88; 95% CI, 0.77 to 1.01; p = 0.08] |
55.2 59.6 [p = 0.08] |
CI: confidence interval; HR: hazard ratio; m: months; n: number of patients; PFS: progression free survival; ORR: objective response rate; OS: overall survival.
*
95% CI = not reported.
**
HR = not reported.
***
p = not reported.