Toxicity
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 radiation therapy 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 radiation therapy 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
Toxicityr
Grade 3 to 5 |
Radiation therapy alone
(%) |
RT plus cetuximab
(%) |
p-value |
Mucositis |
52 |
56 |
0.44 |
Rash |
1 |
17 |
<0.001 |
Dermatitis |
18 |
23 |
0.27 |
Weight loss |
7 |
11 |
0.12 |
Xerostomia |
3 |
5 |
0.32 |
Dysphagia |
30 |
26 |
0.45 |
Asthenia |
5 |
4 |
0.64 |
Nausea |
2 |
2 |
1.00 |
Dehydration |
8 |
6 |
0.57 |
© New England Journal of Medicine 2006