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- Presentation
Randomized Trial Comparing Surgery, 5-FU, and Photodynamic Therapy for Bowen’s Disease
Description
This randomized multicenter non-inferiority trial compared surgical excision, topical 5-fluorouracil (5-FU), and methyl aminolevulinate photodynamic therapy (MAL-PDT) for Bowen’s disease in 250 patients. The study asked whether non-invasive treatments could be good enough alternatives to surgery, which is highly effective but invasive. At one year, sustained clearance was highest with surgery (97.4%), followed by 5-FU (85.7%) and MAL-PDT (82.1%). Based on the predefined non-inferiority margin, 5-FU did not prove non-inferior to surgery, and MAL-PDT also could not be concluded as non-inferior. Despite lower clearance than surgery, the non-invasive treatments offered meaningful advantages, especially better cosmetic outcomes, with 5-FU also allowing home treatment, treatment of larger areas, and lower cost. The presenter concluded that 5-FU should be considered a first-choice option for many patients with Bowen’s disease to help avoid unnecessary surgery while maintaining good effectiveness and improved cosmesis.
View moreConclusions
- Surgical excision was the most effective treatment for Bowen’s disease, but topical 5-FU still achieved high clearance and was close enough to be considered non-inferior at 12 months.
- MAL-PDT did not meet the non-inferiority threshold versus surgery, so it should not replace excision as confidently as 5-FU.
- Because Bowen’s disease is non-invasive and recurrences can often be treated later, a less invasive strategy can be reasonable if it preserves acceptable effectiveness.
- Non-invasive treatments, especially 5-FU, offer important advantages in cosmetic outcome, which may matter more to patients than the small loss in clearance compared with surgery.
- 5-FU can also be delivered at home, treat multiple lesions, and reduce costs, making it a practical first-choice option for many patients.
- The study suggests clinicians should reconsider routine surgery for Bowen’s disease and balance efficacy, cosmetic results, and cost when choosing treatment.
- Tokez et al. JAMA Dermatol. 2019.