KOLOA, HAWAII — Topical 5% 5-fluorouracil cream is a highly effective yet underutilized treatment option for superficial basal cell carcinomas, Dr. Leon H. Kircik said at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.
It makes particularly strong sense in two patient subgroups in which surgery is not a good option: the frail elderly, and young appearance-oriented patients likely to go ballistic at the sight of the keloidal hypertrophic scar that so often occurs following excision of a skin cancer on the chest, shoulders, or upper back, said Dr. Kircik, a dermatologist in private practice in Louisville.
Topical 5% 5-fluorouracil (5-FU) earned Food and Drug Administration approval for treatment of basal cell carcinoma (BCC) more than 3 decades ago at the same time it received an indication for actinic keratosis. The pivotal clinical trial demonstrated a 93% histologic cure rate in 113 biopsy-proven superficial basal cell carcinomas.
Dr. Kircik recently conducted a confirmatory trial of his own. It involved 29 patients with 31 biopsy-proven BCCs treated with topical 5% 5-FU b.i.d. for up to 12 weeks. Patients were followed via office visits at 3-week intervals.
Histologic cure was documented in 90% of the lesions. The average time to cure was 10.5 weeks. Four BCCs were cured by week 6, 5 by week 9, and 19 by week 12. At each office visit, most patients said they had no pain at all; the rest characterized the pain as mild. Dr. Kircik rated hypopigmentation and scarring as none to minimal at each visit and erythema as mild to moderate. The most impressive measure of patient satisfaction was that nearly everyone indicated a willingness to repeat the therapy in the future. “That's a pretty good sign,” the dermatologist said.
The 90% cure rate with 5-FU in his study is similar to the 93% rate in the older trial. It's comparable as well to the 93% and 90% cure rates with curettage and excision, respectively, reported in large patient series. “The 75%–80% success rate quoted in the package labeling for imiquimod 5% cream is not even close,” Dr. Kircik noted. He characterized frail elderly patients with superficial BCC as “perfect” candidates for a topical therapy with a high cure rate.
“I myself as a Mohs micrographic surgeon know the difficulty of taking these patients from the wheelchair and putting them into the surgical chair. Some of them are on Coumadin, some have pacemakers. And it can be very difficult in these patients to use lidocaine with epinephrine,” he said.
In the past, the expense of several months of topical therapy was prohibitive for many elderly patients. Under the new Medicare Part D, however, the cost of a course of Efudex is covered, with only minimal out-of-pocket expense to the patient.
The other setting in which Dr. Kircik always considers Efudex is in young people leery of scarring. “These are the sort of patients I sometimes send to the plastic surgeon because I don't want to be the one who's going to be giving them that scar. When you have a nonscarring topical treatment with a 90%–93% cure rate, I think that's a good indication.”
Dr. Kircik is a consultant to Valeant Pharmaceuticals International, which markets Efudex.
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