Table 1.
Randomized Phase III trials with cetuximab in SCCHN
| Author | Treatment | N | LRC (months) | OS (months) | PFS (months) | ORR |
|---|---|---|---|---|---|---|
| Locoregionally advanced disease | ||||||
| Bonner et al27,28 | RT | 213 | 14.9* | 29.3 | 64% | |
| RT + cetuximab | 211 | 24.4* | 49 | 74% | ||
| P-value | 0.005 | 0.018 | 0.006 | 0.02 | ||
| Ang et al45 | CRT | 448 | 79.7‡ | 64.3*,† | ||
| CRT + cetuximab | 447 | 82.6‡ | 63.4*,† | |||
| P-value | 0.17 | 0.67 | ||||
| Recurrent/metastatic disease | ||||||
| Vermorken et al68 | Platinum/5-FU | 220 | 7.4* | 3.3 | 20% | |
| Platinum/5-FU + cetuximab | 222 | 10.7* | 5.6 | 36% | ||
| P-value | 0.04 | <0.001 | <0.001 | |||
| Burtness et al67 | Cisplatin + placebo | 60 | 8 | 2.7* | 10% | |
| Cisplatin + cetuximab | 57 | 9.2 | 4.2* | 26% | ||
| P-value | 0.21 | 0.09 | 0.03 | |||
Notes:
*
Primary endpoint;
†
2-year PFS rate;
‡
2-year OS rate.
Platinum/5-FU: cisplatin (100 mg/m2) or carboplatin (AUC 5) on day 1, followed by 5-FU 1000 mg/m2/day as a continuous infusion day 1–4.
Abbreviations: RT, radiotherapy; CRT, chemoradiation; N, number of patients; LRC, locoregional control; OS, overall survival; PFS, progression-free survival; ORR, overall response rate.