Preliminary findings show that the addition of cetuximab (Erbitux) to radiation therapy and chemotherapy may help some patients with head and neck cancer live longer, according to a study presented at the plenary session of the recent Multidisciplinary Head and Neck Cancer Symposium, held in Rancho Mirage, Calif, and cosponsored by the American Society for Therapeutic Radiology and Oncology, the American Society for Clinical Oncology, and the American Head and Neck Society. Researchers are recommending a larger trial to prove definitively if cetuximab combined with radiation helps improve survival for these patients.
Researchers at the University of Maryland Medical Center in Baltimore designed the study to evaluate the efficacy of the addition of cetuximab with concurrent chemotherapy and radiation in patients with locally advanced squamous cell carcinoma of the head and neck in order to improve locoregional control and overall survival. Patients received an initial dose of cetuximab followed by weekly doses of the drug, along with daily radiation therapy treatments and weekly doses of chemotherapy.
Of 21 patients enrolled, 18 have completed all therapy and were available for analysis of toxicity and response. No grade 4 toxicities were reported. However, 89% reported mouth pain and 11% reported skin problems. Other toxicities included difficulty swallowing, fever, and a drop in white blood cell count. Seventy-two percent achieved a complete response 2 months after completion of therapy. Ultimately, 95% were disease-free after all therapy.
Side Effects Evaluation
Another study presented at the symposium showed that the addition of cetuximab to radiation therapy treatments does not increase the rate or duration of some side effects in the treatment of advanced head and neck cancers. This study was an in-depth look at outcomes from a study published in the New England Journal of Medicine in 2006, which showed that patients with locally advanced head and neck cancer who were given cetuximab in addition to radiation therapy not only experienced a survival benefit, but also had no increase in mucositis or dysphagia compared with 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 3 months. Of the patients with mucositis, 28% experienced this toxicity for 3 months. Of those with dysphagia, 31.5% experienced this toxicity for 3 months. Fewer than 10% suffered from these toxicities for more than 15 weeks. These findings were similar for the two treatment arms.