Combined cetuximab and radiotherapy improve disease control and survival for patients whose advanced head and neck tumor over-expresses epidermal growth factor receptor, according to a presentation at the Annual International Conference on Molecular Targets and Cancer Therapeutics.

The conference is coordinated by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC).

The current study, a Phase III trial, involved 424 patients with locoregionally advanced squamous cell carcinoma of the head and neck (disease restricted to the pharynx/larynx and cervical lymph nodes). Patients were randomized to radiation alone or radiation plus cetuximab, which was started at 400 mg/m2 followed by 250 mg/m2 for the duration of radiation treatment.

Median age was 57 years, and 80 percent were male. Patients were stratified according to Karnofsky performance status, tumor stage, nodal involvement, and radiotherapy treatment fractionation regimen.

Median survival was 49 months with cetuximab plus radiation compared with 29 months for radiation alone, coupled with a 26-percent reduction in mortality risk. The three-year survival rates for cetuximab plus radiation were 56 percent compared with 45 percent for radiation alone. The benefits were achieved with minimal increase in radiation-associated toxicity.

“We believe the combination of cetuximab and radiotherapy represents a unique therapeutic option for treating patients with locoregional squamous cell carcinoma of the head and neck,” said James Bonner, MD, a professor at the University of Alabama, Birmingham and lead investigator of the study. “These results will provide a much needed platform for additional efforts aimed at further improvements in outcomes.”