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

Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):684-91. doi: 10.1016/j.ijrobp.2005.08.005. Epub 2005 Oct 21.

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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Amifostine / administration & dosage*
  • Amifostine / adverse effects
  • Antineoplastic Agents / adverse effects
  • Carboplatin / therapeutic use
  • Combined Modality Therapy
  • Disease Progression
  • Double-Blind Method
  • Female
  • Head and Neck Neoplasms / drug therapy*
  • Head and Neck Neoplasms / radiotherapy*
  • Humans
  • Injections, Intravenous
  • Male
  • Middle Aged
  • Radiation Injuries / prevention & control*
  • Radiation-Protective Agents / administration & dosage*
  • Radiation-Protective Agents / adverse effects
  • Stomatitis / etiology
  • Stomatitis / prevention & control*
  • Survival Rate
  • Xerostomia / etiology
  • Xerostomia / prevention & control*

Substances

  • Antineoplastic Agents
  • Radiation-Protective Agents
  • Carboplatin
  • Amifostine