• 3/21/2005
  • National Cancer Institute Clinical Trial Results

As reported at the American Society of Clinical Oncology annual meeting, New Orleans, LA, 2004

Background:
Head and neck cancers account for three percent of all cancers in the United States. Most of these cancers begin in squamous cells found in the lining of structures in the head and neck. Initial treatment options for patients with advanced head and neck cancer include radiation therapy, chemotherapy combined with radiation treatment, or surgery followed by radiation and/or chemotherapy plus radiation for patients whose tumors can be surgically removed.

Many head and neck cancer cells overexpress (make too much of) a protein called the epidermal growth factor receptor (EGFR), which may help cancer cells to grow more aggressively. Cetuximab is a monoclonal antibody that attaches to and blocks EGFRs. Early studies suggested that treatment with cetuximab would boost the effectiveness of radiation therapy in patients with head and neck cancer.

The Study:
A total of 424 patients in the United States and Europe were enrolled in this study. All had tumors in their tonsils, tongue, or voicebox that may have involved lymph nodes, but had not spread to other parts of the body. Patients were randomly assigned to receive either radiation therapy alone or radiation plus weekly cetuximab. Patients were followed up for a median of just over three years. The study’s principal investigator was James A. Bonner, M.D., of the University of Alabama at Birmingham. (See the protocol summary.)

Results:
Median survival for patients treated with cetuximab was 54 months, compared with 28 months for patients who received radiation therapy alone. Fifty-seven percent of the cetuximab-treated patients survived for three years, compared with 44 percent of those in the radiation-only group.

Mucositis (inflammation in the mouth), causing pain and difficulty swallowing, is a common side effect of radiation therapy for head and neck cancer. In this study, patients in both groups suffered from this side effect in roughly equal numbers.

“It is particularly encouraging that the increase in survival achieved with cetuximab was attained with no worsening of radiation-induced adverse effects,” said Bonner. Patients treated with cetuximab suffered more frequently from a skin rash on the face and body, but this did not appear to reduce the effectiveness of treatment.

Comments:
The addition of chemotherapy to radiation has also previously been shown to improve outcomes in patients with locally advanced head and neck cancer, says Scott Saxman, M.D., of the National Cancer Institute’s Cancer Therapy Evaluation Program. Follow-up studies will be necessary to determine the relative benefit of cetuximab compared to chemotherapy, he adds, and to determine whether combining cetuximab with chemotherapy will provide even greater benefit.