Table 1.
| Study | Disease | Treatment arms | N | Results (red indicates statistically significant result) | Toxicity/Notes |
|---|---|---|---|---|---|
| Alabama-Birmingham Bonner et al., 2006, 2010 Phase III |
Head and neck cancer All sites |
|
424 | 3 y locoregional control: 34% RT vs. 47% RT + cetuximab Median OS: 2.4 y RT vs. 4.1 y RT + cetuximab 5 y OS: 36% RT vs. 46% RT + cetuximab |
Grade 2+ rash: 61% with cetuximab No difference in QOL |
| RTOG 0522 Ang et al., 2014 Phase III |
Head and neck cancer All sites |
|
895 | 3 y OS: 73% chemoRT vs. 76% chemoRT + cetuximab 3 y PFS: 61% chemoRT vs. 59% chemoRT + cetuximab 3 y DM: 13% chemoRT vs. 10% chemoRT + cetuximab |
Grade 3–4 mucositis higher with cetuximab More skin toxicity with cetuximab |
| TREMPLIN Lefebvre et al., 2013 Randomized Phase II |
Head and neck cancer Larynx Hypopharynx |
Induction docetaxel/cisplatin, if response:
|
116 | 3 mo larynx preservation: 95% RT + cisplatin vs. 93% RT+ cetuximab 18 mo OS: 92% RT + cisplatin vs. 89% RT+ cetuximab |
Treatment compliance higher in cetuximab arm Similar results with induction chemo followed by RT alone |
| Italian Study Group Ghi et al. 2012, 2013 Randomized Phase II |
Head and neck cancer All sites |
2×2 factorial design
|
421 | Complete response: 36% chemoRT vs. 39% cetuximab-RT Median PFS: 21.6 mochemoRT vs. 20.7 mo cetuximab-RT Median OS: 44.7 mo chemoRT vs. 44.7 mo cetuximab-RT |
Primary endpoint was in field grade 3–4 toxicity: Mucositis 29% chemoRT vs. 23% cetuximab-RT Skin reaction: 11% chemoRT vs. 14% cetuximab-RT |
| CONCERT-1 Mesia et al., 2015 Randomized phase II |
Head and neck cancer All sites |
|
153 | 2 y locoregional control; 68% chemoRT vs. 61% chemoRT+ panitumumab |
Serious toxicity rate: 32% chemoRT vs. 43% chemoRT + panitumumab |
| CONCERT-2 Giralt et al., 2015 Randomized phase II |
Head and neck cancer All sites |
|
152 | 2 y locoregional control: 61% chemoRT vs. 51% panitumumab-RT | Serious toxicity rate: 40% chemoRT vs. 34% panitumumab-RT |
| RTOG 0324 Blumenschein et al., 2011 Phase II |
Nonsmall cell lung cancer | Radiation with carboplatin/paclitaxel + cetuximab | 93 | Response rate: 62% Median OS: 22.7 months 2 y OS: 49% |
Grade 4 hematological toxicity: 22% Grade 3 esophagitis :8%; G3-4 pneumonitis: 7% 5 treatment related deaths |
| CALGB 30407 Govindan et al., 2011 Randomized Phase II |
Nonsmall cell lung cancer |
|
101 | 18 mo OS: 58% chemoRT vs. 54% chemoRT + cetuximab | Grade 3+toxicity: 76% ChemoRT vs. 85% ChemoRT + cetuximab |
| Netherlands Van den Heuvel et al., 2014 Randomized Phase II |
Nonsmall cell lung cancer |
|
102 | Local control: 84% chemoRT vs. 92% chemoRT + cetuximab 1 y OS:82% chemoRT vs. 71% chemoRT + cetuximab |
Toxicity similar between groups |
| RTOG 0617 Bradley et al., 2015 Phase III |
Nonsmall cell lung cancer |
|
544 |
|
Grade 3+toxicity increased with cetuximab: 86% vs. 70% |
| StarPan/STAR-02 Pinto et al., 2011 Phase II |
Rectal cancer | Preoperative radiation with 5-FU/oxaliplatin + panitumumab | 55 | Pathological CR: 21% Pathological downstaging: 58% |
Grade 3–4 diarrhea: 39% |
| US Oncology McCollum et al., 2014 Randomized Phase II |
Rectal cancer |
|
139 | Pathologic CR: 28% chemoRT vs. 27% chemoRT + cetuximab 5 y RFS: 61% chemoRT vs. 64% chemoRT + cetuximab |
Higher grade 3–4 diarrhea with cetuximab: 16% vs. 22% |
| EXPERT-C Dewdney et al., 2012 Randomized Phase II |
Rectal cancer KRAS and BRAF wild-type |
Preoperative chemotherapy followed by:
|
90 |
|
In the entire study population of 160 patients there were no significant differences in all endpoints. Benefit was only seen in KRAS/BRAF wild type tumors. |
| ECOG 2205 Gibson et al., 2010 Phase II |
Esophageal cancer | Preoperative radiation with 5-FU/oxaliplatin + cetuximab followed by postoperative docetaxel and cetuximab | 22 | Pathologic CR: 32% | Four post-operative deaths |
| SWOG 0414 Tomblyn et al., 2012 Phase II |
Esophageal cancer | Definitive radiation with cisplatin/irinotecan + cetuximab | 21 | 2 y OS: 33% 2 y PFS: 24% Response rate: 18% |
Grade 3 toxicity: 48%; Grade 4 toxicity: 29% Two treatment related deaths Non-operative patients |
| HOG G05-92 Becerra et al., 2013 Phase II |
Esophageal cancer | Preoperative radiation + cetuximab | 39 | Pathological CR: 37% | Treatment well tolerated No chemotherapy |
| SCOPE1 Crosby et al., 2013 Randomized Phase II/III |
Esophageal cancer |
|
258 | Failure free at 24 weeks: 77% chemoRT vs. 64% chemoRT + cetuximab Median OS: 25 months chemoRT vs. 21 months chemoRT + cetuximab |
Increased grade 3–4 toxicity with cetuximab: 79% vs. 63% |
| RTOG 0436 Suntharalingam et al., 2014 Phase III |
Esophageal cancer |
|
344 | Clinical CR: 59% chemoRT vs. 56% chemoRT + cetuximab 2 y OS: 42% chemoRT vs. 44% chemoRT + cetuximab |
Grade 4+ toxicity higher with cetuximab: 26% vs. 18% |