Subcutaneous Amifostine May Be as Effective as Intravenous Administration

February 1, 2002

Data from a phase II study of subcutaneous amifostine (Ethyol) presented at the 43rd annual meeting of the American Society for Therapeutic Radiology and Oncology suggested that subcutaneously administered amifostine may provide the same protective effects against radiation therapy-induced xerostomia as intravenous administration.

Data from a phase II study of subcutaneous amifostine(Ethyol) presented at the 43rd annual meeting of the American Society forTherapeutic Radiology and Oncology suggested that subcutaneously administeredamifostine may provide the same protective effects against radiation therapy-inducedxerostomia as intravenous administration.

"We are pleased with the growing popularity of amifostine amongradiation oncologists to prevent xerostomia in patients receiving radiotherapyfor head and neck cancers," said Robert Hirsch, phd, vice president ofmedical affairs at MedImmune, Inc (manufacturer of Ethyol). "While the drugis effective when administered intravenously, we believe a subcutaneousformulation would make it significantly more convenient for both patients andradiation oncologists. We are planning to study subcutaneous administration ofamifostine through additional clinical testing in early 2002."

Adverse Effects Similar With IV Administration

In the study, 54 patients were treated with subcutaneous injections ofamifostine 60 minutes prior to receiving radiation therapy. Following treatment,acute xerostomia was observed in 56% of these patients, a rate comparable to the51% of patients experiencing acute xerostomia after receiving intravenousamifostine during the drug’s pivotal phase III trial. Moreover, there were noreports of grade 3 hypotension or nausea/vomiting following subcutaneousamifostine (3% and 7%, respectively). Cutaneous toxicity was the mostsignificant side effect, with grade 3 cutaneous toxicity occurring in 13% ofpatients.