Toxicity
In the CO 17 study, there were no statistically significant differences between the cetuximab group and the supportive-care group in the incidence of grade 3 or higher adverse events, with the exception of rash (11.8% for cetuximab vs. 0.4% for supportive care, P<0.001), infection without neutropenia (12.8% vs. 5.5%, P=0.003), confusion (5.6% vs. 2.2%, P=0.05), and pain defined as "other" according to the NCI-CTC (14.9% vs. 7.3%, P=0.005).r
Haematological adverse events were uncommon, and there were no significant differences between the groups in grade 3 or higher serum chemical values or other laboratory measurements, with the exception of hypomagnesaemia, which was more common in the cetuximab group than in the group receiving supportive care alone (5.8% vs. 0.0%, P<0.001). Grade 3 or 4 infusion reactions (hypersensitivity) occurred in 4.5% of patients assigned to cetuximab.r
In the studies looking at the biweekly cetuximab combination regimens, there were no increased adverse events, including allergic reactions and skin toxicity associated with the double dose.r
Toxicity of cetuximab (weekly) plus best supportive care vs best supportive care aloner
© New England Journal of Medicine 2007