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| |  ASCO MEETING: Ethyol Reduces Radiation Side Effects In Head And Neck Cancer LOS ANGELES, CA -- May 19, 1998 -- Results of a 315-patient, multi-centre trial demonstrated that U.S. Bioscience, Inc.’s Ethyol(R) (amifostine) significantly reduced the incidence of chronic as well as acute xerostomia (dry mouth) and associated symptoms in patients undergoing radiotherapy for the treatment of head and neck cancer. The Phase III clinical trial results were reported during an oral presentation at the American Society of Clinical Oncology annual meeting by David Brizel, M.D., associate professor of radiation oncology at Duke University Medical Center and one of the principal investigators of the study. Xerostomia is a common, serious and often irreversible side effect of radiation therapy for the treatment of head and neck cancer. Patients with xerostomia may experience difficulty speaking and eating and are at increased risk for dental cavities, loss of teeth, and oral bone loss and infections. These symptoms can have a pronounced effect on patients' quality of life. In the Phase III study, patients were randomised to receive daily radiation therapy alone or daily radiation therapy plus 200 mg/m2 Ethyol administered 30 minutes prior to treatment. Radiation toxicities were measured using the Radiation Therapy Oncology Group (RTOG) Acute and Late Radiation Morbidity Scoring Criteria as well as a patient benefit questionnaire. The data showed that 78 percent of patients who were treated with radiation alone experienced moderate to severe xerostomia during and up to one month following radiation. This was reduced to 50 percent in patients who received Ethyol. Importantly, this benefit to salivary gland function was maintained. At one year following therapy, the data on approximately half the patients in the study showed that 60 percent of patients who received radiation alone had moderate to severe xerostomia, compared to 34 percent of patients who were pre-treated with Ethyol. The results of the patient benefit questionnaire correlated with the physicians' assessments. One year following therapy, patients treated with Ethyol reported significantly less mouth dryness and need for fluid supplementation and oral comfort aids than patients treated with radiation alone. At a median follow-up of 13 months for all patients, there was no difference between the treatment arms with respect to disease-free or overall survival. "It is important for radiation oncologists to ensure that in the process of attempting to cure our patients, we also try to preserve the quality of their lives," Dr. Brizel said. "The results of this trial are significant in demonstrating that Ethyol can reduce the incidence of xerostomia according to accepted medical criteria as well as according to patients who provided self-assessments of their symptoms." Ethyol is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin-based chemotherapy in patients with advanced ovarian or non-small cell lung cancer. More information on: Ethyol.
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