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Predictive testing with 5‐fluorouracil

Allergic contact dermatitis to topical fluorouracil has been reported (e.g. see Goette & Odom 1977 a,b). Five of six patients had received two courses of fluorouracil treatment. To assess the sens1t1zmg capacity of fluorouracil in "predictive" assays, guinea pig and human predictive allergy testing was performed. The guinea pig maximization test (Magnusson & Kligman 1970) using 2.5 % concentration of fluorouracil for both intradermal and topical induction and elicitation gave negative results in eight of eight animals. Intradermal challenge with fluorouracil 1 % in saline/buffer was also negative. In 200 human volunteers, a modified Draize test (Marzulli & Maibach 1973) using a 1 % fluorouracil cream was negative. Thus, 5fluorouracil was a weak sensitizer in these tests. The correlation of these experiments to the clinical epidemiology is difficult. Do the two publications (Goette & Odom 1977 a,b) represent a peculiar cluster in an otherwise rare occurrence? Does allergic contact dermatitis to fluorouracil flourish in the abnormal skin in which the drug is used? Are these cases, in fact, photoallergic, rather than allergic? Did our predictive assay yield a false negative result because of failure to utilize intradermal challenge in man, or should we have utilized ultraviolet light in both the assays? Was the test concentration in man too low? Further study is required to settle these issues.