Author(s): Buentzel J, Micke O, Adamietz IA, Monnier A, Glatzel M,
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Abstract PURPOSE: Clinical trials demonstrated the efficacy and safety of intravenous (i.v.) or subcutaneous (s.c.) amifostine for reducing xerostomia and mucositis after radiotherapy or radiochemotherapy for head-and-neck cancer. This randomized, double-blinded, placebo-controlled, phase III study evaluated the efficacy and safety of i.v. amifostine during radiochemotherapy for head-and-neck cancer. METHODS AND MATERIALS: Patients from European and American study centers received i.v. amifostine 300 mg/m2 (n = 67) or placebo (n = 65) before carboplatin 70 mg/m2 and radiotherapy on Days 1 to 5 and 21 to 25, and i.v. amifostine 200 mg/m2 or placebo before radiotherapy on other days. RESULTS: Toxicity incidences were (amifostine, placebo, p value): Grade 2 or higher acute xerostomia (39\%, 34\%, 0.715), Grade 3 or higher acute mucositis (39\%, 22\%, 0.055), Grade 2 or higher late xerostomia (37\%, 24\%, 0.235), and Grade 3 or higher treatment-related adverse events (42\%, 20\%, 0.008). One-year rates of locoregional failure, progression-free survival, and overall survival were not significantly different between treatments. CONCLUSIONS: The used amifostine doses were not able to reduce the toxicity of simultaneous radiochemotherapy for head-and-neck cancer. The safety of amifostine and the lack of tumor protection were consistent with previous studies.
This article was published in Int J Radiat Oncol Biol Phys
and referenced in Atherosclerosis: Open Access