Drug Insight: Cetuximab in the Treatment of Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

Jacques Bernier


Nat Clin Pract Oncol. 2008;5(12):705-713. 

In This Article

Summary and Introduction


Patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) have a poor prognosis, particularly those whose disease has progressed on previous platinum-containing therapy. The epidermal growth factor receptor (EGFR) is expressed at very high levels in SCCHN and is associated with a poor prognosis. Several phase II–III studies have shown that the EGFR-targeting monoclonal antibody, cetuximab, offers clinical benefit for patients with SCCHN. Cetuximab monotherapy is active in patients whose cancer progresses on platinum-containing therapy. Tumor response and patient survival are in excess of what is achieved with commonly used therapies in this setting. Addition of a platinum regimen to cetuximab in patients with disease that progresses on platinum seems to confer no further benefit over cetuximab alone, either in terms of response rate or survival. In the first-line setting, cetuximab plus platinum and 5-fluorouracil significantly prolongs overall survival compared with platinum and 5-fluorouracil alone. The superior survival observed with cetuximab compared with platinum-based treatment demonstrates that cetuximab is the most active treatment for recurrent and/or metastatic SCCHN, and is of particular clinical significance.


The epidermal growth factor receptor (EGFR)-targeting IgG1 monoclonal antibody cetuximab is an example of the advantages offered by targeted therapy in the clinical setting. Cetuximab is the first targeted therapy to show a significant benefit in head and neck cancer, and received FDA regulatory approval for use in this setting. Approval of this agent for locally advanced squamous cell carcinoma of the head and neck (SCCHN) was based on the results of a landmark trial, in which the combination of cetuximab and radiotherapy led to significant improvements in median overall survival (49 months versus 29.3 months; hazard ratio for death 0.74, P = 0.03) and locoregional control (24.4 months versus 14.9 months; hazard ratio for locoregional progression or death 0.68, P = 0.005) compared with radiotherapy alone.[1] In addition to demonstrating the efficacy of cetuximab in this setting, the trial confirmed that the administration of cetuximab does not compromise the delivery of scheduled doses of radiotherapy: patient compliance with radiotherapy was balanced between the treatment arms. Cetuximab is now widely approved in European and non-European countries for use in combination with radiotherapy in locally advanced SCCHN, and in combination with irinotecan for the treatment of patients with EGFR-expressing, KRAS wild-type metastatic colorectal cancer (mCRC). In the US and countries in central and south America and Asia, single-agent cetuximab is approved for use in patients with recurrent and/or metastatic SCCHN progressing despite chemotherapy, in patients with mCRC with disease progression, and in those who are intolerant to irinotecan.


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