Skip to main navigation
Skip notifications
Access to POEMs and Essential Evidence Plus will no longer be included in CMA membership as of Dec. 1, 2023.
Search
5% fluorouracil is the preferred treatment for actinic keratoses
Clinical Question
What is the best approach to treat multiple actinic keratoses in a single field?
Bottom line
The use of topical 5% fluorouracil (5-FU) is most likely to result in successful elimination of actinic keratoses in a field on the head or face. Treatment is self-applied twice daily for 4 weeks, which may create a barrier to adherence for some patients (even in this trial, where adherence should be optimal, 12% of patients were nonadherent). The impact of treatment on longer term outcomes, such as progression to squamous cell carcinoma, are not reported in this 1-year study 1b
Reference
Study design: Randomized controlled trial (single-blinded)
Funding: Government
Setting: Outpatient (specialty)
Synopsis
The best field treatment for actinic keratoses (treatment of multiple lesions in a single continuous field) has not been established. These investigators recruited 1174 patients from 4 Dutch dermatology clinics, of whom 624 met eligibility criteria (at least 5 actinic keratoses in a 25-cm to 100-cm contiguous area of the head or neck). The median age of participants was 73 years, 89% were men, and approximately half the lesions were on the face with the other half on the top of the head or vertex. The patients were randomized to receive 1 of 4 treatments: 5-FU, imiquimod, ingenol mebutate, or methyl aminolevulinate photodynamic therapy (MAL-PDT). Patients in the imiquimod group were evaluated at 1 month, and were retreated if they were classified as a treatment failure (< 75% lesion response). This retreatment of treatment failure was also done for the other 3 treatment groups at 3 months. Those who failed a second course of treatment were classified as treatment failures for the final assessment of outcomes, which occurred at 12 months. Only 2 to 5 patients in each group withdrew. A modified intention-to-treat analysis found that 5-FU had the best results, with a cumulative success rate of 75% (compared with 54% for imiquimod, 38% for MAL-PDT and only 29% for ingenol mebutate). The per-protocol analysis had similar findings, as did an analysis of patients limited to grade I or II actinic keratoses. Adverse events were common and similar across groups, with early severe burning pain much more common among those undergoing MAL-PDT. US pricing based on GoodRx (4/12/19) was $83 for 5-FU, $23 for imiquimod, and $1037 for ingenol mebutate.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Comments
Actinic Keratosis
Can you comment on the role of laser resurfacing on the treatment of AK and prevention of SCC? How does it compare to topical treatments?
Thank you.
Another option not included?
While working in Australia in the years 2000-2004, the universal treatment for (VERY prevalent) Actinic Keratoses was cryotherapy.......... in the form of jets of liquid nitrogen.
(one of my colleagues ambushed my bald scalp with it while I sat at my desk!)
Are there any studies comparing 5FU and other pharmacological agents with Liquid N2?
Incorrect dosing of 5-FU
I reviewed the original article in the NEJM. In the supplementary appendix, the authors describe treatment methods for each agent. 5-FU was self applied twice daily for 4 weeks. Not once weekly as stated in the "Bottom Line". Important difference.
Incorrect dosing of 5-FU
Agreed. I was just about to make the same comment. It's a large enough error that Joule should have re-sent the email with a correction. Someone I know was just prescribed Efudex twice weekly for 4 weeks for her actinic keratosis- I wonder if that dosing regimen was because of this POEM?