A Phase II Trial of Subcutaneous Amifostine and Radiation Therapy in Patients with Head and Neck Cancer (WR-B060)

Diana Stripp, MD
University of Pennsylvania Cancer Center
Last Modified: November 7, 2001

Presenter: P. Anne
Presenter's Affiliation: Radiation Oncology, Thomas Jefferson University Hospital, Philadelphia, PA
Type of Session: Scientific


  • Amifostine is an organic thiophosphate that protects normal tissues from the cytotoxic effects of radiation therapy (RT) and has been shown, in a Phase III trial of RT ± amifostine in head and neck cancer patients, pretreatment with intravenous (IV) amifostine significantly reduced the incidence of > Grade 2 acute/late xerostomia. Brizel, JCO 2000.
  • Preclinical data has suggested subcutaneous (SC) amifostine protects against RT-induced xerostomia and ameliorates side effects known to occur with IV amifostine, such as nausea, vomiting and hypotension.

    Materials and Methods

  • Two 250mg SC amifostine injections were given 60 minutes prior to RT (1.8-2.0 Gy/day for 25-35 fractions).
  • Xerostomia was graded according to RTOG criteria.
  • 54/55 enrolled patients were evaluable for xerostomia and results compared to the Phase III trial with IV amifostine.


  • The acute xerostomia in this trial with SC amifostine was the same level as that observed in the Phase III trial of IV amifostine
  • No Grade 3 hypotension or Grade 3 nausea/vomiting following SC amifostine were seen (3% and 7%, respectively with IV).
  • Grade 3 generalized cutaneous toxicity occurred in 13% of patients (3% with IV).

    Author's Conclusions

  • Findings suggest SC amifostine provides comparable protective effects against RT-induced acute xerostomia, and reduces the amifostine-related side effects of nausea, vomiting and hypotension.
  • The cutaneous reactions reported in this trial are being investigated in further programs using prophylactic measures.

    Clinical/Scientific Implications
    Protection against RT induced acute xerostomia is comparable between SC and IV amifostine. However, the side effect profiles are different. Effort is being made for using prophylaxis to decrease the cutaneous side effect of SC amifostine which overall provides a better and easier route of administration and less of systemic side effects as compared to IV amifostine.

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