Ethyol® Can Be Administered Subcutaneously to Prevent Xerostomia

Ethyol® Can Be Administered Subcutaneously to Prevent Xerostomia

According to an article recently published in the International Journal of Radiation, Oncology, Biology and Physics, Ethyol® (amifostine) can be administered subcutaneously (injection under the skin) for prevention of xerostomia (dry mouth) caused by radiation in the treatment of head and neck cancer.

Head and neck cancers originate in the throat, larynx (voice box), pharynx, salivary glands, or oral cavity (lip, mouth, tongue). Most head and neck cancers involve squamous cells, which are cells that line the mouth, throat, or other structures.

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.

For head and neck cancer patients treated with radiation therapy, xerostomia is a potential side effect of treatment. 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 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, drugs called radiation protectors have been tested in laboratories 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. Although Ethyol can be administered intravenously, offering the option of subcutaneous administration of this agent may increase its use.

Researchers recently conducted a clinical trial to evaluate the subcutaneous administration of Ethyol among 54 patients with head and neck cancer who were treated with radiation therapy. These results were compared to findings from a previous trial that compared intravenous Ethyol to placebo (inactive substitute) among patients with head and neck cancer who were also treated with radiation therapy.

  • Grades 2 or greater xerostomia occurred in 56% of patients.
  • Delayed xerostomia, which occurs at a later time following therapy, occurred in 45% of patients.
  • With subcutaneous administration of Ethyol, the incidence and severity of xerostomia was comparable to that observed with intravenous administration of Ethyol in the previous study.
  • Rates of cancer recurrences and survival with subcutaneous administration of Ethyol were consistent with predicated outcomes.

The researchers concluded that the subcutaneous administration of Ethyol appears to provide similar results to intravenous administration of Ethyol in preventing xerostomia among patients receiving radiation therapy for head and neck cancer. Because subcutaneous administration is easier than intravenous administration, this may ultimately increase the use of Ethyol in this patient population.

Reference: Anne PR, Machtay M, Rosenthal DI, et al. A Phase II trial of subcutaneous amifostine and radiation therapy in patients with head and neck cancer. International Journal of Radiation Oncology Biology Physics. 2007;67:445-452.

Related News: Additional Evidence that Ethyol® Reduces Dry Mouth in Patients with Head and Neck Cancer (7/31/2006)

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