Table 2.
Clinical trials with anti-EGFR monoclonal antibodies in first-line treatment.
| Study | No. of patients | Design | Treatment | Primary end point | Results | p |
|---|---|---|---|---|---|---|
| CRYSTAL [27] | 1198 | Phase 3, open-label, RCT | FOLFIRI versus C-mab + FOLFIRI | PFS | HR, 0.85; 95% CI, 0.72–0.99 | 0.048 |
|
| ||||||
| OPUS [28] | 337 | Phase 2, open-label, RCT | FOLFOX4 versus C-mab + FOLFOX4 | ORR | 37% versus 61%∗ | 0.011 |
|
| ||||||
| MRC COIN [29] | 1630 | Phase III, open-label, RCT | FOLFOX versus C-mab + FOLFOX | OS | HR, 1.04; 95% CI, 0.87–1.23∗ | 0.67 |
| CapeOx CapeOx | ||||||
|
| ||||||
| NORDIC VII [30] | 571 | Phase III, open-label, RCT | Nordic FLOX versus C-mab + FLOX versus C-mab + intermittent FLOX | PFS | HR, 0.89; 95% CI, 0.72–1.11 | 0.31 |
|
| ||||||
| PRIME [31] | 1183 | Phase III, open-label, RCT | FOLFOX4 versus P-mab + FOLFOX4 | PFS | HR, 0.8; 95% CI, 0.66–0.97∗ | 0.02 |
∗Results were analyzed with tumors harboring wild-type exon 2 KRAS
EGFR: epidermal growth factor receptor; No., number; RCT: randomized controlled trial; C-mab: cetuximab; PFS: progression-free survival; HR: hazard ratio; ORR: objective response rate; OS: overall survival; CapeOx: capecitabine plus oxaliplatin; P-mab: panitumumab.