FDA gives greenlight for new treatment of head and neck cancer

Mar 5 2006

The U.S. Food and Drug Administration has approved colon cancer drug Erbitux to treat head and neck cancer after results of a large clinical trial showed the drug prolonged survival by 20 months.

Erbitux is designed for use in combination with radiation therapy for the treatment of squamous cell cancer of the head and neck, which cannot be removed by surgery.

Approximately 40,000 people in the U.S. are diagnosed with head and neck cancer every year.

Cancers of the head and neck comprise several types of cancer; these include the nasal cavity and sinuses, oral cavity, nasopharynx, oropharynx, and other sites throughout the head and neck area.

Squamous cell carcinoma of the head and neck is the most common type of head and neck cancer.

Head and neck cancers are more common in men and in people over age 50.

Tobacco and alcohol are factors that increase the risk of these cancers which affect the mouth, nose, sinuses, and throat.

Standard treatment is largely determined by the extent to which the cancer has spread and by the specific locations within the head or neck area where the cancer is located.

The patient’s overall medical condition is a deciding factor and treatment usually consists of radiation therapy, chemotherapy with surgery, or surgery alone.

Once head and neck cancer has spread from its original site, long-term outcomes are generally poor and treatment often results in a compromised quality of life.

This is the first new therapy for head and neck cancer since the 1950s.

Unlike many chemotherapy drugs that work by poisoning cancer cells, Erbitux is an antibody and blocks the effect of a major growth factor that is responsible for causing cancers to grow.

Erbitux was previously approved by the FDA to be used in combination with Camptosar (irinotecan) for the treatment of colorectal cancer that no longer responds to chemotherapy.

The drug is also approved as a single agent in patients who are not able to tolerate treatment with irinotecan.

Erbitux is also being evaluated in clinical trials for the treatment of various other types of cancers.

The multi-national clinical trial that prompted FDA approval of Erbitux was originally set up to evaluate the addition of Erbitux to radiation therapy in the treatment of head and neck cancer which had spread from site of origin but not to distant sites in the body.

The trial included 424 patients and while half were treated with Erbitux plus high-dose radiation therapy, the other half received high-dose radiation therapy alone.

It was found in an average follow-up of 54 months, that the patients treated with the addition of Erbitux to radiation therapy had improved outcomes compared to those treated with radiation therapy alone.

The period of remission for the patients treated with the Erbitux/radiation therapy was 24.4 months, compared to only 14.9 months for those treated with radiation therapy alone.

Overall survival time was 49 months for those treated with Erbitux/radiation therapy, compared to only 29.3 months for those treated with radiation therapy alone.

Progression-free survival was also significantly improved for patients treated with Erbitux/radiation therapy.

Rash and reactions at the site of infusions were the most common side effects experienced by patients treated with Erbitux, along with fatigue and nausea.

The researchers concluded that the addition of Erbitux to radiation therapy is well tolerated and improves overall survival compared to radiation therapy alone in the treatment of patients with head and neck cancer.

Patients diagnosed with head and neck cancer should speak with their physician regarding their individual risks and benefits of treatment with Erbitux.