The authors were interested in the use of cetuximab, an epidermal growth factor receptor inhibitor, to treat human papillomavirus (HPV)-positive oropharyngeal cancer and whether this will be less toxic than standard cisplatin treatment. They conducted an open-label, randomised controlled phase 3 trial in Ireland, the Netherlands and the UK in patients aged ≥18 years with HPV-positive low-risk oropharyngeal cancer (non-smokers or lifetime smokers with a smoking history of <10 pack-years). Patients were randomised (1:1) to receive, in addition to radiotherapy (70 Gy in 35 fractions), either IV cisplatin (100 mg/m2 on days 1, 22 and 43 of radiotherapy) or IV cetuximab (400 mg/m2 loading dose followed by seven weekly infusions of 250 mg/m2). The primary outcome was overall severe (grade 3-5) toxicity events at 24 months from the end of therapy. 334 patients were enrolled. Overall (acute and late) severe (grade 3-5) toxicity did not differ significantly between the two treatment groups at 24 months with the mean number of events per patient being 4·8 with cisplatin and 4·8 with cetuximab. At 24 months, overall all-grade toxicity also did not differ significantly with the mean number of events per patient being 29·2 with cisplatin and 30·1 with cetuximab). However, the authors did find a significant difference between cisplatin and cetuximab in 2-year overall survival (97·5% vs. 89·4%; hazard ratio [HR] 5·0, 95%CI 1·7-14·7) and 2-year recurrence (6·0% vs. 16·1%; HR 3·4, 1·6-7·2). Therefore, compared with the standard cisplatin regimen, cetuximab shows no benefit in terms of reduced toxicity and is actually less effective in terms of tumour control.
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