New treatment option gives hope to victims of head and neck cancers

Oct 19 2006

More than 640,000 people worldwide are diagnosed with head and neck cancer each year, and more than 350,000 die from the disease annually.

In just this year alone more than 55,000 Americans will be diagnosed with the disease and 13,000 will die.

Head and neck cancer is a group of many related diseases that mostly begin in the cells that line the mucosal surfaces in the head and neck area such as the mouth, nose and throat.

This includes cancers of the oral cavity, salivary glands, paranasal sinuses and nasal cavity, pharynx, larynx, and lymph nodes in the upper part of the neck.

Survival rates for advanced head and neck cancer are historically low.

Most head and neck cancers begin in the squamous cells that line the mucosal surfaces in the head and neck and tobacco and alcohol use are the most important risk factors for the cancers.

Symptoms usually include a lump or sore (for example, in the mouth) that does not heal, a sore throat that does not go away, difficulty swallowing, and a change or hoarseness in the voice.

Survival rates for advanced head and neck cancer are historically low and treatment options are limited and depend on a number of factors, including the exact location of the tumor, the stage of the cancer, and the person’s age and general health.

The good news for victims is however that the Food and Drug Administration (FDA) in the U.S. has given approval for the drug Taxotere to be used to treat advanced squamous cell carcinomas of the head and neck (SCCHN) which are inoperable.

Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research says Taxotere will provide a new treatment option that has been shown to help slow the spread of the disease and prolong patients' survival.

Taxotere was approved following a trial of 358 patients with previously untreated, inoperable, locally advanced SCCHN.

The patients were divided into two groups; one received Taxotere in combination with the chemotherapy drugs cisplatin and fluorouracil, and the other received only cisplatin and fluorouracil. Chemotherapy was given prior to radiation therapy and surgery was allowed after chemotherapy, either before or after radiation therapy.

The patients in the Taxotere arm of the trial experienced a longer survival time (18.6 months versus 14.2 months) and a longer time to disease progression or death (11.4 months versus 8.3 months) than the group on cisplatin and fluorouracil alone.

The most frequent adverse reactions reported during the trial by the patients on Taxotere were decreases in white and red blood cells, loss of hair, inflammation of the mouth and esophagus, and nausea.

Compared to patients in the control arm, patients on Taxotere had greater hair loss, decreases in white blood cells, fever or infection with low white blood cells, fluid retention, diarrhea and neurosensory abnormalities.

Taxotere is manufactured by Sanofi-Aventis and is expected to also be given approval by the European authorities for the treatment of SCCHN.