Table 2.
Selected Phase II and III trials of cetuximab in R/M HNSCC
| Phase | Sample size | Treatment regimen | Primary endpoint(s) | RR | Median PFS (months) | Median OS (months) |
|---|---|---|---|---|---|---|
| First-line | ||||||
| Randomized III41 | 117 | Arm A: cetuximab + cisplatin | PFS | A: 26% | A: 4.2 | A: 9.2 |
| Arm B: cisplatin + placebo (crossover to Arm A allowed after October 2000 for patients with PD) | B: 10% (P=0.03) | B: 2.7 | B: 8.0 | |||
| Randomized III42 | 442 | Arm A: cetuximab + cisplatin/5-FU | OS | A: 36% | A: 5.6 | A: 10.1 |
| Arm B: cisplatin/5-FU alone | B: 20% (OR, 2.33; 95% CI, 1.50–3.60; P<0.001) | B: 3.3 (HR, 0.54; 95% CI, 0.43–0.67; P<0.001) | B: 7.4 (HR, 0.80; 95% CI, 0.64–0.99; P=0.04) | |||
| Nonrandomized II107 | 54 | Cetuximab + cisplatin + docetaxel | RR | 54% | 7.1 | 15.3 |
| Nonrandomized II108 | 46 | Cetuximab + paclitaxel | RR | 54% | 4.2 | 8.1 |
| Platinum-resistant | ||||||
| Nonrandomized II109 | 96 | Cetuximab + platinum-based chemotherapy | RR | 10% | NR | 183 days |
| Nonrandomized II110 | 84 | Cetuximab + docetaxel | RR | 11% | 3.1 | 6.7 |
| Nonrandomized II111 | 66 | Cetuximab + cisplatin + pemetrexed | PFS | 29.3% | 4.4 | 9.7 |
| Nonrandomized II112 | 130 | Platinum + 5-FU or taxane ×2 cycles If SD or PD → then: platinum + cetuximab | RR | SD: 18% PD1: 20% PD2a: 6% |
SD: 4.9 PD1: 3 PD2a: 2 |
SD: 11.7 PD1: 6.1 PD2a: 4.3 |
| Randomized II113 | 61 | Arm A: cetuximab 500 mg/m2 every 2 weeks | RR | A: 11% | A: 2.2 | A: 7.4 |
| Arm B: cetuximab 750 mg/m2 every 2 weeks (closed early due to lack of efficacy) | B: 8% | B: 2.0 | B: 9.4 | |||
| Nonrandomized II114 | 103 | Cetuximab monotherapy | RR | 13% | NR | 178 days |
Notes:
a
PD2 corresponds to patients who failed platinum-based therapy within 90 days of receipt of treatment.
Abbreviations: R/M, recurrent or metastatic; HNSCC, head and neck squamous cell carcinoma; RR, response rate; PFS, progression-free survival; OS, overall survival; PD, progressive disease; 5-FU, 5-fluorouracil; OR, odds ratio; CI, confidence interval; HR, hazard ratio; SD, stable disease; NR, not reported.