The addition of the targeted agent Erbitux® (cetuximab) to radiation therapy significantly improves survival compared with radiation therapy only. These results were recently presented at the 2008 annual meeting of the American Society of Therapeutic Radiation and Oncology (ASTRO).
Head and neck cancers originate in the throat, larynx (voice box), pharynx, salivary glands, or oral cavity (lip, mouth, tongue). Most head and neck cancers involve squamous cells, which are cells that line the mouth, throat, or other structures.
Erbitux is a type of targeted therapy called a monoclonal antibody. It works by binding to a protein receptor located on many cancer cells called the epidermal growth factor receptor (EGFR). EGFR is involved in cellular growth and replication, and by targeting EGFR, the spread of cancer can be reduced or delayed. The majority of squamous cell head and neck cancers have some type of mutation within EGFR.
Researchers conducted an international Phase III clinical trial (phase prior to FDA review) that compared Erbitux plus radiation therapy with radiation therapy only among patients with head and neck cancer that had spread from the site of origin but not to distant sites in the body. The trial included 424 patients who had not received prior therapy. Patients were followed for five years.
- Median overall survival was 49 months for patients treated with Erbitux/radiation compared with only 29.3 months for those treated with radiation only.
- At five years, survival was 45% for those treated with Erbitux/radiation compared with only 36% for those treated with radiation therapy only.
- Skin rash and reactions at the site of infusion were the only side effects associated with the addition of Erbitux.
The researchers concluded that the addition of Erbitux to radiation therapy significantly improves overall survival compared with radiation therapy alone in the treatment of head and neck cancers.
Reference: Imclone Systems, Inc. Erbitux® five-year data show significant improvement in overall survival for patients with locally or regionally advanced head and neck cancer. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=97689&p=irol-newsArticle&ID=1199509&highlight=. Accessed September 2008.