Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: a randomized placebo-controlled phase III study.

Author(s): Buentzel J, Micke O, Adamietz IA, Monnier A, Glatzel M, de Vries A

Affiliation(s): Department of Otolaryngology, Head & Neck Surgery, Suedharzkrankenhaus Nodhausen, Nordhausen, Germany. jens.buentzel@shk-ndh.de

Publication date & source: 2006-03-01, Int J Radiat Oncol Biol Phys., 64(3):684-91. Epub 2005 Oct 21.

Publication type: Clinical Trial, Phase III; Multicenter Study; Randomized Controlled Trial

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.