Four patients discontinued cetuximab due to hypersensitivity reactions after the test dose or first dose. Eight other patients discontinued due to grade 3 rash, <5% of patients required a dose reduction, 14% required a dose delay by at least 4 days due to a rash. Cetuximab did not appear to exacerbate the common radiotherapy side effects experience by the patients.
Severe late effects associated with radiation was reported in 20% of patients in each group, most commonly affected sites were oesophagus, salivary glands, larynx mucous membranes, subcutaneous tissues, bone and skin. Twelve patients in the radiotherapy group and 11 patients in the combined group died within 60 days of the last treatment, no death was known to be related to cetuximab.r
Some studies have reported an increased severity of toxicities.r
Grade 3 to 5
|RT plus cetuximab
© New England Journal of Medicine 2006
There is currently no high level evidence comparing cetuximab with chemotherapy in this patient setting. The RTOG 0522 trial, now close to accrual, is a phase III randomised control trial comparing chemoradiotherapy (2 doses of 3 weekly cisplatin) with chemoradiotherapy plus cetuximab in patients with squamous cell carcinoma of the oropharynx, hypopharynx, or larynx; selected stage III-IV disease (T2N2-3M0, T3-4 any N M0). The primary endpoint is disease free survival.r Initial results reported at ASCO 2011,r show that the addition of cetuximab did not improve progression-free or overall survival and was associated with higher rates of mucositis and cetuximab-induced skin reactions.