Table 1.
Completed clinical trials with cetuximab in SCCHN
| Trial | N. patients | Phase | Design | Endpoints | Results | Setting |
|---|---|---|---|---|---|---|
| Burtness et al10 | 117 | III | CDDP-cetuximaba | OS | Not significant | First-line |
| vs | PFS | Not significant | Recurrent/metastatic | |||
| CDDP | ORR | Significant (p = 0.03) | ||||
| Bourhis et al11 | 53 | II | CDDP-5FU-cetuximab | ORR | 36% | First-line |
| Recurrent/metastatic | ||||||
| Vermorken et al12 | 442 | III | CDDP-5FU-cetuximaba | OS | Significant (p = 0.04) | First-line |
| vs | PFS | Significant (p = 0.001) | Recurrent/metastatic | |||
| CDDP-5FU | ORR | Significant (p = 0.001) | ||||
| Herbst et al13 | 132 | II | CDDP-cetuximab | ORR | 12,8% | Second-line (Platinum-refractory) |
| Recurrent/metastatic | ||||||
| Baselga et al14 | 96 | II | CDDP-cetuximab | ORR | 10% | Second-line (Platinum-refractory) |
| Recurrent/metastatic | ||||||
| Vermorken et al15 | 96 | II | Cetuximab | ORR | 13% | Second-line (Platinum-refractory) |
| Recurrent/metastatic | ||||||
| Bonner et al26 | 424 | III | Radiotherapy-cetuximaba | PFS | Significant (p = 0.005) | Locally advanced disease |
| vs | OS | Significant (p = 0.003) | ||||
| Radiotherapy | ORR | Significant (p = 0.02) | ||||
| Pfister et al28 | 21 | II | Radiotherapy-CDDP + cetuximaba | ORR | 94% | Locally advanced disease |
| vs | ||||||
| Radiotherapy-CDDP |
Notes:
a
Experimental arm.
Abbreviations: OS, overall survival; PFS, progression free survival; ORR, overall response rate.