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ASCO: Ethyol (Amifostine) Reduces Radiation Therapy-Induced Dry Mouth In Head And Neck Cancer Patients NEW ORLEANS, LA -- June 23, 2004 -- Data presented from a Phase 3 clinical trial involving 303 head and neck cancer patients showed that Ethyol® (amifostine) reduced the incidence of moderate-to-severe dry mouth (xerostomia) in patients receiving radiation therapy for their disease. The data also showed that two years after treatment, patients treated with Ethyol retained the ability to produce saliva. Further, the data showed no evidence of tumor protection for the 24-month period of the study. The data were presented at the American Society of Clinical Oncology's (ASCO) 40th Annual Meeting. "We found that two years after treatment, amifostine continues to diminish xerostomia induced by radiation therapy for head and neck cancer without evidence of any compromise in the efficacy of the radiotherapy," said David M. Brizel, MD, Professor of Radiation Oncology, Duke University Medical Center and principal investigator of the study. Xerostomia is the medical term for chronic and severe dry mouth. It is a debilitating and sometimes permanent condition caused by a reduction in salivary gland function, commonly caused by radiation therapy to treat cancer of the head and neck region. The salivary glands are very sensitive to radiation and may be exposed during treatment resulting in a reduction in the production of stimulated and unstimulated saliva in the mouth. About the Clinical Trial The Phase 3 clinical trial was conducted at 40 centers in North America and Europe. Patients were randomized to one of two groups: group 1 (the control group) received 1.8 to 2.0 gamma rays (Gy) of radiation to treat their cancer; group 2 were given the same dose of radiation, but also received Ethyol by intravenous infusion 15 to 30 minutes prior to each of their radiation treatments. Both groups received treatment for five to seven weeks for a total dose of 50-70 Gy. The Ethyol group received the drug at 200 milligrams per meter squared (mg/m2). Xerostomia was assessed at 12, 18 and 24 months after radiotherapy by Radiation Therapy Oncology Group (RTOG) criteria. Radiotherapy efficacy was assessed by locoregional tumor control, progression-free survival and overall survival. In addition, quality of life was assessed by a patient benefit questionnaire with eight questions scored from 1 (severe negative impact) to 10 (no impact). Ethyol significantly reduced the incidence of moderate-to-severe (Grade€2) xerostomia at each follow-up visit. At 24 months, only 20 percent of Ethyol patients had Grade€2 xerostomia versus 36 percent in the control group (p=0.002). Ethyol also significantly increased the percentage of patients who could produce meaningful quantities of saliva (>0.1 grams) at 24 months (76 percent in the Ethyol group versus 56 percent in the control group (p=0.01)). In the study, tumor control, progression-free survival and overall survival at each follow-up visit were not significantly different between treatment groups. At 24 months, overall survival was 72 percent in the Ethyol group versus 67 percent in the control group (p=0.184). Mean overall scores for the patient benefit questionnaire tended to improve with Ethyol. At 24 months, patients in the Ethyol group scored their quality of life at 7.24 versus 6.87 in the control group (p=0.229). About Ethyol Ethyol is a cytoprotective agent used to reduce some toxicities associated with cancer chemotherapy and radiotherapy. Specifically, this drug is an intravenous organic thiophosphate agent indicated to reduce the incidence of moderate-to-severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. Ethyol is also indicated for the reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer or non-small cell lung cancer (NSCLC). For full prescribing information, visit www.medImmune.com. SOURCE: MCS Public Relations E-mail this page to a friend or colleague! To print, use this version