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Fluorouracil cream, 5%, shows long-term efficacy in treatment, prevention of actinic keratosis

After a single course of treatment, topical fluorouracil cream, 5%, effectively reduced actinic keratosis counts and the long-term need for spot treatment in a high-risk population, according to recently published study results.

Researchers studied 932 veterans who were recruited from 12 Veterans Affairs medical centers from 2009 to 2011 and had two or more keratinocyte carcinomas during the 5 years prior to enrollment. Four hundred and sixty-eight patients were randomly assigned to topical fluorouracil cream, 5%, and 464 were randomly assigned to vehicle cream (control), which was applied to the face and ears twice daily for up to 4 weeks, or a total of 56 doses. Mean follow-up was approximately 2.6 years across the two groups.

The mean total count of actinic keratoses (AKs) on the face and ears at enrollment was similar between the two cohorts, with 11.1 in the patients treated with fluorouracil and 10.6 in the control group. At 6 months after randomization, the fluorouracil cohort had a 73% reduction in the number of AKs on the face and ears to 3 per participant, whereas the control cohort had a 24% reduction to 8.1 AKs per participant. The fluorouracil continued to have fewer mean total count of AKs at 42 months after randomization compared with the control cohort (4.3 vs. 5.7).

There were higher complete AK clearance rates at 6 months (38% vs. 17%) and fewer spot treatments at 6-month intervals, study visits and between study visits in the fluorouracil group compared with controls, according to the researchers.

The researchers observed 6,491 total individual spot AK treatments in the fluorouracil group and 12,204 in the control cohort for up to 42 months after randomization, with median time to first spot treatment of 6.2 months in the fluorouracil group and 6 months in the control cohort. Additionally, the fluorouracil cohort displayed fewer hypertrophic AKs at 6 months (0.23) compared with controls (0.41), the researchers reported. – by Bruce Thiel

Disclosures: Pomerantz reports no relevant financial disclosures. Please see the study for a full list of other researchers’ relevant financial disclosures.