Ethyol® Improves Dry Mouth Without Affecting Survival in Head and Neck Cancer

Ethyol® Improves Dry Mouth Without Affecting Survival in Head and Neck Cancer Patients

According to a recent article published in the International Journal of Radiation Oncology, Biology and Physics, the agent Ethyol® (amifostine) protects against xerostomia (abnormally dry mouth) while not affecting long-term outcomes in patients with head and neck cancer who undergo radiation therapy.

Approximately 40,000 people in the U.S. are diagnosed with head and neck cancer every year. Cancers of the head and neck include cancers of the nasal cavity, and sinuses, mouth, and throat. According to the American Cancer Society, 11,000 people died from head and neck cancer in 2004.

Standard treatment for head and neck cancer is largely determined by the stage (extent to which the cancer has spread) and by the specific locations within the head or neck area where the cancer has spread. Radiation therapy and chemotherapy tend to be commonly used.

Unfortunately, side effects caused by radiation therapy (ulcers, dry mouth, burning of the tissue at the site where radiation is aimed) are common. In addition to drastically reducing the quality of life of patients, these side effects often cause a delay or cancellation of administration of chemotherapy or additional radiation therapy. Postponing of missing just one dose of therapy may result in compromised outcomes, including a worsening of overall survival. Therefore, complete prevention of these side effects is crucial in providing optimal outcomes.

Xerostomia refers to a condition of an abnormally dry mouth. Patients with severe xerostomia have very limited or virtually no saliva production. This results in difficulty eating, speaking, and swallowing. These symptoms make xerostomia is extremely uncomfortable, and patients who suffer from the condition have a drastically reduced quality of life. Xerostomia can last long after treatment is completed.

Over the past 50 years, many drugs called radiation protectors have been tested in the laboratory for prevention of radiation damage to normal cells and tissues. In order for such drugs to effectively treat cancer, they must protect only normal cells-not the cancer cells-from radiation. Ethyol is a radiation protector and the only drug that has been approved by the U.S. Food and Drug Administration (FDA) for use in patients receiving radiation therapy for cancers of the head and neck. There has been worry, however, that the use of Ethyol may result in worse outcomes for patients.

Researchers recently conducted a clinical trial to directly compare the long-term outcomes of patients with head and neck cancer who received Ethyol to those who did not receive Ethyol. This trial included over 300 patients who underwent radiation therapy for treatment of head and neck cancer. Approximately half of the patients received a dose of Ethyol administered 1530 minutes prior to radiation therapy, while the other half underwent radiation only and did not receive Ethyol.

Overall, dry mouth was improved and long-term outcomes were not compromised with the use of Ethyol:

  • At over 2 years follow-up, use of Ethyol resulted in a significantly reduced incidence of xerostomia.
  • Overall survival, progression-free survival, and control of the cancer at or near the site of origin (local control) were similar between the patients who received Ethyol and those who did not receive Ethyol.

The researchers concluded that Ethyol significantly improves xerostomia in patients with head and neck cancer who are treated with radiation therapy. Furthermore, Ethyol does not compromise outcomes in these patients, as overall survival, progression-free survival, and local control was similar to patients who did not receive Ethyol in this trial. Patients diagnosed with head and neck cancer may wish to speak with their physician regarding their individual risks and benefits of receiving treatment with Ethyol.

Reference: Wasserman T, Brizel D, Henke M, et al. Influence of intravenous amifostine on xerostomia, tumor control, and survival after radiotherapy for head-and- neck cancer: 2-year follow-up of a prospective, randomized, phase III trial. International Journal of Radiation Oncology, Biology and Physics. 2005; 63: 985-990.

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