PURPOSE: To review reports of severe skin reactions during amifostine treatment.
METHODS AND MATERIAL: The expert panel reviewed postmarketing reports of skin reactions and discussed strategies for evaluation and management.
RESULTS: Between 1994 and April 2002, 35 events were classified as severe skin reactions worldwide: erythema multiforme (8), Stevens-Johnson syndrome (10), toxic epidermal necrolysis (11), toxicoderma (3), and bullae (3). Unadjusted incidences were 6-9 per 10,000 radiotherapy patients and 0.8-1 per 10,000 chemotherapy patients. In 10 patients (29%) amifostine was continued after cutaneous signs and symptoms appeared.
CONCLUSIONS: Practical recommendations for practicing clinicians were developed. Cutaneous evaluation for rash, ulceration, or lesions-particularly on lips/mucosa, palmar/plantar surfaces, and the trunk-should be performed before amifostine administration. Reactions can be classified as local injection site/radiation port reactions or non-injection site reactions; and non-injection site reactions with associated fever or constitutional symptoms must be differentiated from radiation-induced dermatitis or cutaneous reaction with another etiology. Amifostine should be permanently discontinued for severe skin reactions or reactions associated with constitutional symptoms not known to be due to any other etiology. Increased physician awareness, proper patient management, monitoring before administration, and early intervention/discontinuation for non-injection site reactions may reduce the incidence of cutaneous reactions and enhance amifostine safety.