Table 4. Toxicities encountered during randomised studies evaluating EGFR antibodies in advanced colorectal cancer.
| Study | Treatment arms | Number of evaluable patients | Grade 3/4 diarrhoea (%) | Grade 3/4 nausea + vomiting (%) | Grade 3/4 hypo-magnesiumia (%) | Grades 2–4 skin reaction (%) | All grades infusion reaction (%) |
|---|---|---|---|---|---|---|---|
| CRYSTAL | FOLFIRI | 602 | 10.5 | 5.0 | 0.2a | 0.2 | 0 |
| FOLFIRI + cetuximab | 600 | 15.7 | 4.7 | 1.8a | 19.7 | 2.5 | |
| OPUS | FOLFOX | 168 | 7 | NR | 0 | 0.6 | 2 |
| FOLFOX + cetuximab | 170 | 8 | NR | 2 | 18 | 5 | |
| PACCE | FOLFOX/BEV | 397 | 13 | 7 | 0 | 1 | NR |
| FOLFOX/BEV/PAN | 407 | 24 | 13 | 4 | 36 | NR | |
| PACCE | FOLFIRI/BEV | 113 | 9 | 8 | 1 | 0 | NR |
| FOLFIRI/BEV/PAN | 111 | 28 | 13 | 5 | 38 | NR | |
| CAIRO2 | CAPOX/BEV | 366 | 19.1 | 16.7 | NR | 20.8 | 4.1 |
| CAPOX/BEV/cetuximab | 366 | 26 | 12.3 | NR | 39.1 | 4.9 | |
| EPIC | Irinotecan | 650 | 16.2 | 11.6 | 0.4 | 0.5 | 0.8 |
| Irinotecan + cetuximab | 648 | 28.8 | 11.7 | 3.3 | 8.2 | 1.4 | |
| BOND | Cetuximab | 115 | 1.7 | 4.3 | NR | 5.2 | 3.5 |
| Irinotecan + cetuximab | 212 | 21.2 | 7.1 | NR | 9.4 | 0 | |
| NCIC CO 17 | BSC | 274 | NR | 11 | 0 | 0.4 | 0 |
| BSC + cetuximab | 288 | NR | 11.2 | 5.8 | 11.8 | 4.5 | |
| PANITUMUMAB | BSC | 234 | 0 | 1 | 0 | 9 (all grades) | 0 |
| BSC + panitumumab | 239 | 1 | 3 | 3 | 90 (all grades) | 0 | |
| MABEL | Irinotecan + cetuximab | 1147 | 19.4 | 5.3 | NR | 13.3 | 12.7 |
a
Only 20% of patients had serum magnesium measurement.
FOLFOX=oxaliplatin/infused 5-FU/LV; BEV=bevacizumab; FOLFIRI=irinotecan/infused 5-FU/LV; BSC=best supportive care; PAN=panitumumab; NR=not reported.