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Data Show Ethyol(R) Reduces Radiation Therapy-Induced Dry Mouth
in Head and Neck Cancer Patients For 24 Months
NEW ORLEANS, June 6 /PRNewswire-FirstCall/ -- Data presented today from a
Phase 3 clinical trial involving 303 head and neck cancer patients showed that
Ethyol(R) (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
today 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 greater
than or equal to 2) xerostomia at each follow-up visit. At 24 months, only 20
percent of Ethyol patients had Grade greater than or equal to 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
http://www.medimmune.com/.
About MedImmune, Inc.
MedImmune is a leading biotechnology company focused on researching, developing
and commercializing products to prevent or treat infectious disease, autoimmune
disease and cancer. MedImmune actively markets four products, Synagis(R)
(palivizumab), Ethyol(R) (amifostine), FluMist(TM) (Influenza Virus Vaccine
Live, Intranasal), and CytoGam(R) (cytomegalovirus immune globulin intravenous
(human)), and has additional products in clinical testing. MedImmune employs
approximately 1,800 people, is headquartered in Gaithersburg, Maryland, and has
additional operations in Frederick, Maryland, as well as Pennsylvania,
California, the United Kingdom and the Netherlands. For more information on
MedImmune and its products, visit the company's website at
http://www.medimmune.com/.
DATASOURCE: MedImmune, Inc.
CONTACT: Media & Investors - Lori Weiman, Vice President, Corporate
Communications and Investor Relations of MedImmune, +1-301-398-4321, or Media
- Jeff Hoyak of MCS Public Relations, 1-800-477-9626
Web site: http://www.medimmune.com/