Table 1.
Cetuximab – Bio-Radiotherapy Phase III Trials.
| Trials | Study years |
Study arms |
Chemo therapy |
HPV positive a | Median F/U (years) |
Progression free survival | Overall survival | Comment |
|---|---|---|---|---|---|---|---|---|
| IMCL 9815 | 1999–02 | RT + CET RT |
– | 41% | 4.5 | – | 55% v/s 45%b,e | Cetuximab is better |
| RTOG 0522 | 2005–09 | RT + CIS + CET RT + CIS |
3 weekly Cisplatin |
70% | 3.8 | 59% v/s 61%c,e | 76% v/s 72%c,e | No benefit More toxicity |
| GORTEC 2007–01 | 2008–14 | RT + CT + CET RT + CET |
Carboplatin +5 FU |
21% | 4.4 | 53% v/s 40%b,e | 61% v/s 55%c,e | No OS benefit CT - different |
| GORTEC 2007–02 | 2009–13 | TPF → RT + CET RT + CT |
Carboplatin +5 FU |
21% | 2.8 | 32% v/s 32%c,e | 38% v/s 42%c,e | No benefit More toxicity |
| RTOG 1016 | 2011–14 | RT + CET RT + CIS |
3 weekly Cisplatin |
100% | 4.5 | 67% v/s 79%b,f | 78% v/s 85%b,f | Cetuximab is Detrimental |
| DE-ESCALATE | 2012–16 | RT + CET RT + CIS |
3 weekly Cisplatin |
100% | 2.1 | – | 89% v/s 97%b,d | Cetuximab is Detrimental |
| ARTSCAN III | 2013–18 | RT + CET RT + CIS |
Weekly Cisplatin (40 mg/m2) |
90% | 3.1 | 67% v/s 88%b,e | 78% v/s 88%c,e | No benefit of Cetuximab |
| TROG 12.01 | 2013–18 | RT + CET RT + CIS |
Weekly Cisplatin (40 mg/m2) |
100% | 4.1 | 80% v/s 93% b,e | – | Cetuximab is Detrimental |
CET – Cetuximab; CIS – Cisplatin; CT – Chemotherapy; TPF – Docetaxel, Cisplatin and 5-Fluoro Uracil.
a = among oropharyngeal primary; b = p value significant; c = p value not significant; d = 2Y; e = 3Y, f = 5Y.