Cetuximab prolongs survival in metastatic head and neck SCC

A European randomised study (EXTREME) in 422 patients has shown that the addition of cetuximab to platinum based chemotherapy in metastatic or recurrent squamous cell carcinoma of the head and neck region increases median survival from 7.4 to 10.1 months.This study was presented by Dr Jan Vermorken. He summarised the role of over expression of the epidermal growth factor receptor (EGFR) in head and neck cancer, the mechanism of action of cetuximab and the results of two earlier studies. This was a multicentre study involving 80 sites in 17 European countries. There was no screening for EGFR overexpression. Patients were randomised to receive standard therapy of carboplatin or cisplatin and 5FU every 3 weeks. The experimental arm received the same chemotherapy and a loading dose of cetuximab followed by weekly. A maximum of 6 cycles were given. The experimental arm received maintenance cetuximab. Treatment was continued until disease progression or unacceptable toxicity.The primary endpoint was overall survival with duration of response, time to progression, response rate, quality of life and safety as secondary endpoints. The presentation concentrated on the primary endpoint as the other data had not been completely analysed.The main inclusion criteria were recurrent or metastatic head and neck cancer unsuitable for curative therapy and KPS ? 70. Nasopharyngeal cancer was excluded. The median age was 56 with 54% having locoregional recurrence. Pretreatment characteristics were well balanced. Approximately 80% had had prior radiotherapy and 40% chemotherapy.Toxicity was acceptable similar between the two arms except for rash and infusion reaction. The median survival in the experimental arm was increased from 7.4 to 10.1 months (HR 0.80). The one year survival was 39 v 31%. No differential effect was seen on subgroup analysis.He stated that this was the first systemic treatment to show any advantage over platinum based chemotherapy in the last 25 years....