Objective: To review the pharmacology, pharmacokinetics, clinical evidence, and safety, as well as the potential directions for use, of the epidermal growth factor receptor (EGFR) monoclonal antibody cetuximab.
Data sources: A MEDLINE search (1966-December 2005) was conducted using the following terms: cetuximab, Erbitux, C225, epidermal growth factor receptor, and EGFR. Additional information was obtained via meeting abstracts, bibliographies from relevant articles, national guidelines, and the manufacturer.
Study selection and data extraction: Preclinical and clinical trials utilizing cetuximab in the treatment of solid tumors were selected from the data sources. All published, randomized clinical trials involving cetuximab in treatment of metastatic colorectal cancer and studies providing a description of the pharmacology, pharmacokinetics, safety, or efficacy were included in this review.
Data synthesis: Many solid tumors overexpress EGFR, making it an ideal target for anticancer agents. Cetuximab is the only EGFR monoclonal antibody commercially available and is approved for the treatment of EGFR-expressing, metastatic colorectal cancer in patients refractory or intolerant to irinotecan. Data on patients with other solid tumors are encouraging with cetuximab used as monotherapy or in combination with chemotherapy, radiation, or other targeted agents. Common adverse effects include dermatologic and hypersensitivity reactions.
Conclusions: Further clinical data are necessary to clearly define the role of cetuximab in the treatment of patients with solid malignancies, with emphasis on survival and quality-of-life benefits relative to its cost.