Cetuximab (Erbitux), a monoclonal antibody targeting the epidermal growth factor receptor, has proven effective in treating several kinds of head and neck cancer. It was approved last year by the FDA for initial treatment of advanced squamous cell carcinoma of the head and neck (SCCHN). Researchers at last week's ASCO meeting reported the results of the European EXTREME trial, and added to accumulating evidence that cetuximab also has a role in treating the disease when it recurs or metastasizes.

Lead author Dr. Jan B. Vermorken from the University of Antwerp in Belgium called the survival benefit - a 21-percent risk reduction with cetuximab patients surviving 10.1 months, 2.7 months longer than those receiving standard care - "among the longest ever seen in a large clinical trial among these patients." For more than two decades, progress in this setting had plateaued. Patients with recurrent or metastatic SCCHN usually receive platinum-based, palliative chemotherapy, sometimes with an intent to cure, but most do not survive beyond 6 to 7 months.

All 442 patients received standard care: up to six cycles of chemotherapy with 5-fluorouracil plus either carboplatin or cisplatin. The experimental group also received cetuximab, until the disease progressed or unacceptable toxicity levels were reached. The most common side effect associated with cetuximab was a controllable rash.