The epidermal growth factor receptor (EGFR) inhibitor cetuximab is active in recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). The activity of cetuximab was compared with that of commonly used treatments in this setting.

All patients had recurrent and/or metastatic SCCHN and had progressed on cisplatin‐ or carboplatin‐based chemotherapy. Efficacy data from 3 prospective studies (n = 278 patients) that administered cetuximab as a single agent (n = 103 patients) or combined with either cisplatin/carboplatin (n = 96 patients) or cisplatin (n = 79 patients) were compared with the results from a retrospective study of patients who received various second‐line treatments (all treatments including best supportive care only, n = 151 patients; chemotherapy, n = 43 patients). Safety data considered were only those from the cetuximab studies.

Over the 3 cetuximab trials, overall response rates from 10% to 13% and disease control rates from 46% to 56% were observed. The median time to disease progression ranged between 2.2 months and 2.8 months, and the median overall survival ranged between 5.2 months and 6.1 months. No patients who progressed on cetuximab alone responded to additional platinum. These survival data compared favorably with those from the retrospective study (median survival, 3.4 months [n = 151 patients] and 3.6 months [n = 43 patients]). Cetuximab‐based treatments generally were tolerated well, and cetuximab did not increase the side effects associated with platinum therapy.

Cetuximab has the potential to prolong survival in patients with recurrent and/or metastatic SCCHN who fail on platinum therapy compared with various second‐line therapies. Cetuximab did not increase the toxicities associated with chemotherapy. The results obtained by treatment with cetuximab alone after platinum failure did not appear to differ from the results obtained by reintroducing platinum in combination with cetuximab. Cancer 2008. © 2008 American Cancer Society.