Table I.
AEs in cetuximab monotherapy trials31
| Saltz et al. (2004) | Cunningham et al. (2004) | Lenz et al. (2006) | Jonker et al. (2007) | Wierzbicki et al. (2008) | |
|---|---|---|---|---|---|
| n of patients | 57 | 115 | 346 | 287 | 85 |
| Any AE, n (%) | NR | 50 (43.5) | NR | 226 (78.5) | 81 (95.3) |
| Any skin toxicity (%) | 88 | 80 | 82.9 | 88.6 | NR |
| Phase | II | II/III | II | III | II |
| Grade 3/4 AEs, % | Acne, 16; asthenia, 4; atrial fibrillation, 2; hypokalemia, 2; rash, 2; vomiting, 2; confusion, 2; diarrhea, 2; headache, 2 | Dyspnea, 13.0; asthenia, 10.4; acne-like rash, 5.2; abdominal pain, 5.2; nausea/vomiting, 4.3; anemia, 2.6; diarrhea, 1.7; thrombocytopenia, 0.9; stomatitis, 0.9 | Acne, 4.9; asthenia, 2.0; headache, 1.2; diarrhea, 1.2; nausea, 0.6; dry skin, 0.6; fever, 0.3 | Fatigue, 33.0; dyspnea, 16.3; abdominal pain, 13.2; pain–other, 14.9; infection without neutropenia, 12.8: rash or desquamation, 11.8; hypomagnesemia, 5.8; edema, 5.2; anorexia, 8.3; constipation, 3.5; nausea, 5.6; vomiting, 5.6; confusion, 5.6 | Dermatitis, 4.7; hypomagnesemia, 4.7; dyspnea 2.4; headache, 1.2 |
| Onset of skin toxicity | 1–3 wks | 1–3 wks | 8–19 days | NR | NR |
| Infusion reactions, type, n (%) n of patients | Allergic reactions, 3 (5) | Hypersensitivity reaction, 4 (3.5) | Hypersensitivity reaction, 26 (7.5) | Hypersensitivity reaction, 13 (4.5) | Infusion reaction grade ≥3, (3.5) |