Table 3. Toxicities encountered during selected studies evaluating bevacizumab in advanced colorectal cancer.
| Study | Treatment arms | Number of evaluable patients | Grade 3/4 hypertension (%) | Venous thrombosis (%) | Arterial thrombosis (%) | Grade 3/4 bleeding (%) | Grade 2-4 proteinuria (%) | GI perforation (%) |
|---|---|---|---|---|---|---|---|---|
| Kabbinavar et al (2003) | 5-FU/LV | 35 | 0 | 6 | 3 | 0 | NR | NR |
| 5-FU/LV/BEV (5 mg kg−1) | 35 | 9 | 26 | 0 | 0 | NR | NR | |
| 5-FU/LV/BEV (10 mg kg−1) | 32 | 25 | 6 | 6 | 9 | NR | NR | |
| Hurwitz et al (2004) | IFL | 397 | 2 | 11.4 | 1 | 2.5 | 6.6 | 0 |
| AVF 2107 | IFL/BEV | 393 | 11 | 12.5 | 3.3 | 3.1 | 3.9 | 1.5 |
| 5-FU/LV/BEV | 109 | 6.4 | 9.2 | 4.6 | 6.4 | 1.8a | 0 | |
| Kabbinavar et al (2005b) | 5-FU/LV | 104 | 3 | 11 | 5 | 3 | 4 | 0 |
| 5-FU/LV/BEV | 100 | 16 | 9 | 10 | 5 | 8 | 2 | |
| Kabbinavar et al (2005a) | 5-FU/LV or IFL | 237 | 3 | 9 | 3 | 2 | 4 | 0 |
| 5-FU/LV/BEV | 244 | 16 | 10 | 5 | 5 | 9 | 1 | |
| Giantonio et al (2007) | FOLFOX | 285 | 1.8 | 2.5 | 0.4 | 0.4 | 0 | 0 |
| ECOG E3200 | FOLFOX/BEV (10 mg kg−1) | 287 | 6.2 | 3.4 | 0.9 | 3.4 | 0.7 | 1 |
| BEV (10 mg kg−1) | 234 | 7.3 | 0.4 | 0.4 | 2.1 | 0 | 1.3 | |
| Saltz et al (2007) | FOLFOX or CAPOX | 675 | 1 | 5 | 1 | 1 | NR | <1 |
| XELOX-1/NO16966 | FOLFOX or CAPOX/BEV | 694 | 4 | 8 | 2 | 2 | <1 | <1 |
| Hecht et al (2009) | FOLFOX + BEV | 397 | 5 | 12 | NR | NR | NR | 0 |
| PACCE | FOLFOX + BEV + panitumumab | 407 | 4 | 13 | NR | NR | NR | 0 |
| Hecht et al (2009) | FOLFIRI + BEV | 113 | 2 | 11 | NR | NR | NR | NR |
| PACCE | FOLFIRI + BEV + panitumumab | 111 | 3 | 24 | NR | NR | NR | NR |
| Tol et al (2009) | CAPOX + BEV | 366 | 14.8 | 6.8 | 3.3 | 1.6 | NR | 0.3 |
| CAIRO 2 | CAPOX + BEV + cetuximab | 366 | 9.3 | 8.2 | 2.2 | 0.5 | NR | 1.6 |
| Berry et al (2008) BEAT | Chemotherapy + BEV | 1914 | 5.3 | NR | 1.5 | 3.4 | 1.1 | 1.8 |
| Grothey et al (2007) BriTE | Chemotherapy + BEV | 1953 | NR | NR | 1.8 | 2.4 | NR | 1.8 |
a
Only grade 3 toxicity was reported.
LV=leucovorin; FOLFOX=oxaliplatin/infused 5-FU/LV; BEV=bevacizumab; CAPOX=capecitabine/oxaliplatin; IFL=irinotecan/bolus 5-FU/LV; NR=not reported.