The availability of subcutaneously (SC) administered
amifostine may present an advantage for radioprotectant
therapy in
head and neck cancer patients. In a randomized phase II trial comparing SC
amifostine versus no
amifostine in 140 patients undergoing
radiation therapy for head and neck, thoracic, or
pelvic cancers,
amifostine treatment was associated with reductions in mucosal toxicity and delays in
radiation therapy among the 19 patients with
head and neck cancer, as well as in the thoracic and
pelvic cancer groups. A phase II trial of SC
amifostine in
head and neck cancer was performed in a patient population (n = 54) similar to that studied in a phase III trial of intravenous
amifostine to allow comparisons of outcomes. Acute
xerostomia grade 2 occurred in 56% with SC
amifostine and 51% with intravenous
amifostine (78% in the no-
amifostine group in phase III trial), with median time to onset being 40 days and 45 days, respectively (30 days with no
amifostine), and cumulative radiation dose to onset being 58 Gy and 60 Gy (42 Gy with no
amifostine), respectively.
Amifostine SC was well tolerated, with three quarters of patients receiving > or =75% of the planned dose.
Nausea,
vomiting, and
hypotension were less severe with SC
amifostine, but cutaneous toxicity was more frequent. The reduction in
radiation therapy-induced acute
xerostomia with SC
amifostine is similar to that with intravenous
amifostine in patients with
head and neck cancer. If cutaneous toxicity is judged an acceptable risk, SC
amifostine may represent a second, more convenient option for treating physicians.