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Objectives: Cetuximab-induced mucositis has been poorly reported in the literature. The aim of this pilot study was to determine the severity and incidence of oral mucositis in patients treated with radiotherapy plus cetuximab. Materials and methods: Patients treated for a head and neck squamous cell carcinoma (HNSCC) by radiotherapy plus cetuximab (C+) were included. The incidence and severity of mucositis, dysphagia and use of analgesic drugs were reported. Results: 25 patients treated with radiotherapy plus cetuximab were included. The absolute risk of developing severe mucositis was 0.40. Treatment interruption was necessary in 16% of patients, and hospitalization due to side effects was necessary in 12% of patients. Conclusions: Despite the small number of patients, incidence of severe mucositis seems to be higher in patients treated with radiotherapy plus cetuximab. An increased use of morphine appears to be correlated with the severity of mucositis. Pain resulting from oral mucositis is predictive of oral functional impairment. This pilot study highlights the lack of knowledge on cetuximab-induced mucositis, in association with radiotherapy. A prospective multicenter study should be conducted to more precisely evaluate the incidence and severity of mucositis, the time of occurrence, and the impact on quality of life and treatment interruption of patients.

Incidence of mucositis in patients with head and neck squamous cell carcinoma treated with radiotherapy plus cetuximab: a pilot study