Addition of cetuximab to radiotherapy improves duration of control and survival

The addition of cetuximab to radiotherapy significantly improves locoregional control and survial without increasing the common toxic effects of radiotherapy alone, in patients with locoregionally advanced squamous-cell carcinoma of the head and neck.The addition of chemotherapy to radiotherapy markedly increases toxicity, including mucositis and swallowing dysfunction. High levels of expression of the epidermal growth factor receptor (EGFR) are associated with poor outcomes. Radiotherapy increases expression of EGFR and blockage leads to increased cytotoxicity of radiotherapy. Cetuximab is a monoclonal antibody against the epidermal growth factor receptor. This multinational, randomised study compared radiotherapy and cetuximab with radiotherapy alone in patients with locoregionally advanced squamous-cell carcinoma of the head and neck. A total of 213 patients were randomised to high-dose radiotherapy alone and 211 to high-dose radiotherapy plus weekly cetuximab. The primary end point was the duration of control of locoregional disease.Results showed that the median duration of locoregional control was 24.4 months in the cetuximab group and 14.9 months in those given radiotherapy alone (hazard ratio for locoregional progression or death, 0.68; p=0.005). At a median follow-up of 54.0 months, the median duration of overall survival was 49.0 months in the combined group and 29.3 months in the radiotherapy alone group (hazard ratio for death, 0.74; p=0.03). Two-year survival was 62% and 55% and three-year survival was 55% and 45% respectively (p=0.05).The addition of cetuximab significantly increased progression-free survival (hazard ratio for disease progression or death, 0.70, p=0.006). The incidence of grade 3 or greater toxic effects was similar in the two groups, except that Grade 3 and above acneiform rash occurred in 17% of the combined group and 1% of the radiotherapy group and infusion reactions in 3% in the combined group only. Anaemia was higher in the radiotherapy group (1% vs 6%). The authors concluded that the addition of cetuximab significantly improved locoregional control and reduced mortality without increasing the common toxic effects of radiotherapy alone. Well designed trial are needed to compare this combination with chemoradiotherapy.Reference...