SCOTTSDALE, ARIZ. — Although 5% 5-fluorouracil cream received Food and Drug Administration approval for treatment of superficial basal cell carcinoma nearly 4 decades ago, the cream is underused for that indication today, even though it is very well tolerated and is particularly beneficial as an alternative to surgery for many patients, Leon H. Kircik, M.D., said at a meeting sponsored by the Skin Disease Education Foundation.
The cream was first approved by the FDA based on a study showing a 93% cure rate among 54 patients with 113 superficial basal cell carcinoma lesions after an average treatment period of about 6 weeks.
To take a fresh look at the treatment, Dr. Kircik, a dermatologist in Louisville, Ky., conducted a study treating 25 patients with 27 lesions with the 5-FU brand Efudex and found remarkably similar results.
The study showed a cure rate that was just the same—93%, with the average cure time in Dr. Kircik's study of about 10 weeks. Four lesions were cured by week 6, 5 lesions were cured by week 9, and 16 were cured by week 12.
Just as remarkable, however, were findings on patient-reported tolerability, pain, and satisfaction. On a tolerability scale of 1-4, with 1 being “very painful” and 4 being “not painful” at all, the ratings were consistently between 3.5 and 3.8 over the 15-week course.
“Most patients did not complain, and this is unusual,” Dr. Kircik said. “With 5-FU cream use on actinic keratosis patients, there are often many more complaints of pain and discomfort.”
Inclusion criteria in Dr. Kircik's study included lesion diameter greater than 0.5 cm and less than 2.0 cm. Criteria for exclusion included treatment for skin cancer within the last month, pregnancy, or a known sensitivity to the treatment.
Scarring was minimal, with scarring levels between 0.22 and 0.38 on a scale of 0 (no scarring) to 3 (severe scarring) And, in what Dr. Kircik said was the most telling reading, most patients indicated they would be willing to repeat the therapy.
“If you ask this of an actinic keratosis patient, their response is often 'no way,' but there was a very different profile with these patients,” Dr. Kircik said. “There were no serious adverse events, the medication was well tolerated, and there was little to no pain during the course of the treatment.”
Dr. Kircik said he believes that in addition to a relatively high cost, some physicians may shy away from 5-FU cream for superficial BCC treatment because of the higher pain problems they've heard reported by actinic keratosis patients.
The treatment, however, is particularly beneficial for patients such as the elderly, whose overall health could make them poor candidates for surgery, and younger patients with cosmetic concerns, since the treatment has an excellent cosmetic outcome.
Studies furthermore show that 5-FU cream's 93% cure rate is similar to that of other treatments including excision (about 90%) and curettage (93%), Dr. Kircik said.
“Considering that these therapies all have similar cure rates, [you] should consider patient tolerability and the excellent cosmetic outcome factors when considering 5-FU cream,” he said.
Dr. Kircik disclosed that he has received funding either as a consultant or as an investigator from Valeant Pharmaceuticals International, the maker of Efudex, and other pharmaceutical companies.
The Skin Disease Education Foundation and this newspaper are wholly owned subsidiaries of Elsevier.