Background The current approach to advanced head and neck squamous cell carcinoma (AHNSCC) is based on the combination of radiotherapy (RT) and chemotherapy. Recent introduction of monoclonal antibody cetuximab as a radiosensitiser agent has made a significant advance in the treatment of this pathology.

Purpose To evaluate the efficacy and safety of cetuximab in combination with RT in the treatment of AHNSCC and compare our results with those reported in the pivotal trial.

Materials and methods Observational, descriptive and retrospective study. It was followed in patients with AHNSCC who started treatment with cetuximab from 2007 to 2010 in our centre.

Results The authors reviewed 36 patients, 27 men (75%) and 9 women (25%), with an average age at baseline of 66 years (range 35-85). The most common tumour localisations were: 12 oral cavity (33.3%), 9 tongue (25%) and 7 larynx (19.4%). Of all patients, 20 (55.5%) underwent surgery prior to treatment. Patients received a median of 5 administrations (range 1-10) for 38 days (range 1-77). In 25 patients (69.4%) the tumour was stable and in 11 (30.6%) it progressed with a median TTP of 5.1 months. Respect to the toxicity associated with cetuximab-RT, 25 patients (69%) developed some adverse events. Skin toxicity was the most frequent with 16 patients affected (44%), followed by 14 patients with mucositis (39%). 7 (19%) patients The authors had to discontinue treatment and 3 (8%) required hospitalisation.

Conclusions The results obtained are similar to those of the pivotal trial. In our case The authors got worse results in TTP. This may be because the ideal conditions of clinical trials differ from clinical practice. Likewise, the median cycles which received cetuximab in the pivotal trial were over, which could also influence the therapeutic efficacy. The percentage of patients with side effects is high, but it was only necessary to discontinue treatment in a small number of them.