Table II.
AEs in panitumumab monotherapy trials31
| Van Cutsem et al. (2007) | Van Cutsem et al. (2008) | Berlin et al. (2006) | Hecht et al. (2008) | Hecht et al. (2007) | |
|---|---|---|---|---|---|
| 229 | 176 | 93 | 203 | 148 | |
| Any AE, n (%) | 79 (35) | 32 (18) | 23 (25) | 88 (42) | 18 (12) |
| Any skin toxicity (%) | 90% | NR | 96 | NR | 95 |
| Phase | III | II | II | II | II |
| Grade 3/4 AE, % | Acneiform rash, 7.4; abdominal pain, 7.4; erythema, 5.2; dyspnea, 4.8; fatigue, 4.4; anorexia, 3.5; asthenia, 3.1; constipation, 2.6; pruritus, 2.2; skin exfoliation, 2.2; vomiting, 2.2; hypomagnesemia, 3.0; back pain, 1.7; paronychia, 1.3; diarrhea, 1.3; nausea, 0.9; rash, 0.9; skin fissures, 0.9; edema, 0.9; cough 0.4 | Acne, 6.2; erythema, 5.1; rash, 4.5; other skin manifestations, 2.3; paronychia, 1.7; pruritus, 1.1; skin exfoliation, 0.6; diarrhea, 0.6; conjunctivitis, 0.6 | Acneiform rash, 9.9; erythema, 6.6; rash, 3.3; pruritus, 2.2; paronychia, 2.2; hypokalemia, 2.2; exfoliation, 1.1; skin fissures, 1.1; vomiting, 1.1; anorexia, 1.1; hypomagnesemia, 1.1 | Acneiform rash, 6; erythema, 5; pruritus, 3; rash, 3; exfoliation, 3; nausea/vomiting, 2; fatigue/asthenia, 2; diarrhea, 2; dyspnea, 1; infections, 6 | Rash, 3; fatigue, 3; vomiting, 1; pruritus, 1; nausea, 1; diarrhea, 1; dyspnea, 1 |
| Onset of skin toxicity | 12–15 days | NR | 6–13 days | NR | 9–14 days |
| Infusion reactions, type, n (%) | Infusion reaction, 0 (0); only one grade 2 reaction | Moderate hypersensitivity, 1 (0.6) | Infusion reaction, 1 (1) | Infusion reaction, grade 3 or 4, 7 (3) | Hypersensitivity reaction, 1 (0.7) |