Buentzel, J., Micke, O., Adamietz, I.A., Monnier, A., Glatzel, M., & deVries, A. (2006). Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: A randomized placebo-controlled phase III study. International Journal of Radiation Oncology, Biology, Physics, 64, 684–691.

DOI Link

Study Purpose

To evaluate the efficacy and safety of IV amifostine during radiochemotherapy for head-and-neck cancer

Intervention Characteristics/Basic Study Process

Patients in the study group received 300 mg/m2 IV amifostine on the days in which they received carboplatin and radiation therapy (RT). On the days in which they received only RT, they were given 200 mg/m2 IV amifostine.

Sample Characteristics

  • The study reported on 132 patients (67 in the amifostine group and 65 in the placebo group).
  • The median age of patients in the amifostine group was 57 years and the median age of patients in the placebo group was 58 years. Patients' ages ranged from 23–78 years.
  • This was a randomized, double-blind, placebo-controlled, phase III, multicenter study.
  • Patients had been diagnosed with stage III or IV head and neck cancer and were receiving RT and 70 mg/m2 carboplatin.

Setting

The study was conducted between October 1996 and October 1999.

Measurement Instruments/Methods

  • Radiation Therapy Oncology Group (RTOG) scoring was used.
  • The Acute/Late Radiation Morbidity Scoring Criteria were used.

Results

  • Effectiveness not established; no statistical evidence was found to indicate that mucositis was improved with the use of amifostine versus placebo.
  • In the amifostine group, 39% of patients experienced grade 2 or higher xerostomia; in the placebo group, 35% of patients experienced grade 2 or higher xerostomia (p = 0.715).
  • In the amifostine group, 39% of patients experienced grade 3 or higher xerostomia; in the placebo group, 22% of patients experienced grade 3 or higher xerostomia (p = 0.055).
  • In the amifostine group, 47 patients completed the study; in the placebo group, 55 patients completed the study.
  • The most common reactions were nausea/vomiting, hypotension, allergic reaction, and rash.
  • In the amifostine group, 30% of patients discontinued treatment versus 11% in the placebo group.

Conclusions

The intervention was not found to be effective in the management of mucositis toxicity.

Limitations

This was the first randomized and placebo-controlled study of amifostine in the head and neck cancer population.