Table 2.
Effect of cetuximab in phase II/III studies in patients with metastatic colorectal cancer
| Study | Treatment | Phase | Regimen | Patients (n) | Overall response | Median PFS (mo) | Median OS (mo) |
| Cunnigham et al[22], | Refractory to irinotecan | 2 | Irinotecan+ | 218 | 22.90% | 4.1 | 8.6 |
| BOND study, | cetuximab | ||||||
| 2004 | vs | ||||||
| cetuximab alone | 211 | 10.80% | 1.5 | 1.5 | |||
| P = 0.0074 | P < 0.0001 | P = 0.48 | |||||
| Van Cutsem et al[28], | First-line | 3 | FOLFIRI + cetuximab | 105 | 36.20% | 7.6 | 17.5 |
| CRYSTAL trial, | vs | ||||||
| 2009 | placebo | 87 | 40.20% | 8.1 | 17.7 | ||
| (K-Ras mutant) | OR = 0.80 | HR = 1.07 | HR = 1.03 | ||||
| P = 0.75 | |||||||
| FOLFIRI + cetuximab | 172 | 59.30% | 9.9 | 24.9 | |||
| vs | |||||||
| placebo | 176 | 43.20% | 8.7 | 21.0 | |||
| (K-Ras wild-type) | OR = 1.91 | HR = 0.68 | HR = 0.84 | ||||
| P = 0.004 | P = 0.048 | ||||||
| Bokemeyer et al[29,30], | First-line | 2 | FOLFOX + cetuximab | 52 | 33% | 8.6 | NR |
| OPUS trial, | vs | ||||||
| 2008 | placebo | 47 | 49% | 5.5 | NR | ||
| (K-Ras mutant) | OR = 0.507 | HR = 1.83 | |||||
| P = 0.106 | P = 0.0192 | ||||||
| FOLFOX + cetuximab | 61 | 61% | 7.7 | NR | |||
| vs | |||||||
| placebo | 73 | 37% | 7.2 | NR | |||
| (K-Ras wild-type) | OR = 2.54 | HR = 0.57 | |||||
| P = 0.011 | P = 0.016 | ||||||
| Heinemann et al[31], | First line | 3 | FOLFIRI + cetuximab | 297 | 62% | 10.3 | 28.7 |
| FIRE-3, | FOLFIRI + bevacizumab | 295 | 57% | 10.4 | 25.0 | ||
| 2013 | OR = 1.249 | HR = 1.04 | HR = 0.77 | ||||
| P = 0.18 | P = 0.69 | P = 0.017 |
PFS: Progression free survival; OS: Overall survival; NR: Not reported.