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
"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).
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
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.
SOURCE 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 /
CO: MedImmune, Inc.
IN: MTC HEA BIO
SU: SVY TDS
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8577 06/06/2004 14:00 EDT http://www.prnewswire.com