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Cetuximab with radiotherapy does not increase side effects for head and neck cancer patients

January 19, 2007

The addition of Cetuximab (brand name Erbitux) to radiation therapy treatments does not increase the rate or duration of some side effects in the treatment of advanced head and neck cancers, according to a study presented at the plenary session today at the Multidisciplinary Head and Neck Cancer Symposium, co-sponsored by the American Society for Therapeutic Radiology and Oncology, the American Society for Clinical Oncology and the American Head and Neck Society.

This study was an in-depth look at outcomes from a study published in the New England Journal of Medicine in 2006 that showed that patients with locally advanced head and neck cancer who were given Cetuximab in addition to radiation therapy, showed not only a survival benefit, but also that there was no increase in mucositis (reddening, swelling and pain of the mucous membrane) or dysphagia (difficulty or pain when swallowing) over patients who received radiation therapy alone. This study compared the duration of these normal tissue toxicities between the two arms from the NEJM study.

There were 424 patients involved in this study and the median follow-up time was 54 months. For the overall group, the median duration of any mucositis or dysphagia was three months. Of the patients with mucositis, 28 percent experienced this toxicity for three months. Of those with dysphagia, 31.5 percent experienced this toxicity for three months. Fewer than 10 percent suffered from these toxicities for more than 15 weeks. These findings were similar for the two treatment arms.

"These findings are important because they show that the addition of this monoclonal antibody therapy has lifesaving benefits without any additional length of suffering from the primary acute side effects," said James A. Bonner, M.D., lead author of the study and a radiation oncologist at the University of Alabama in Birmingham, Ala.

American Society for Therapeutic Radiology and Oncology

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