Assessment and management of cutaneous reactions with amifostine administration: findings of the ethyol (amifostine) cutaneous treatment advisory panel (ECTAP).
OBJECTIVE
To review reports of severe skin reactions during amifostine treatment.


METHODS
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.
Boccia
Ralph
R
Medical Oncology, Center for Cancer and Blood Disorders, 6420 Rockledge Drive, No. 4100, Bethesda, MD 20817, USA. boccia@dnamail.com
Anné
Pramila Rani
PR
Bourhis
Jean
J
Brizel
David
D
Daly
Carrie
C
Holloway
Nathaniel
N
Hymes
Sharon
S
Koukourakis
Michael
M
Kozloff
Mark
M
Turner
Maria
M
Wasserman
Todd
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004999:Amifostine / Q000009:adverse effects*; D001768:Blister / Q000139:chemically induced / Q000453:epidemiology; D002648:Child; D002675:Child, Preschool; D003875:Drug Eruptions / Q000453:epidemiology / Q000209:etiology*; D004892:Erythema Multiforme / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011837:Radiation-Protective Agents / Q000009:adverse effects*; D013262:Stevens-Johnson Syndrome / Q000139:chemically induced / Q000453:epidemiology / Q000209:etiology
D011837:Radiation-Protective Agents; D004999:Amifostine