5-fluorouracil cream noninferior to surgery for Bowen’s disease

Key takeaways:

• Surgical excision, 5-fluorouracil cream and MAL-PDT were compared in Bowen’s disease treatment.
• Sustained clearance was similar and cosmetic outcomes improved with 5-fluorouracil cream vs. surgical excision.

For patients with Bowen’s disease, 5-fluorouracil was shown to be noninferior to surgical excision and resulted in better cosmetic outcomes, according to a study.

“Bowen’s disease is not invasive and treatment is aimed at decreasing the potential risk of progression into invasive SCC,” Shima Ahmady, MD, of the department of dermatology at Maastricht University Medical Center, and colleagues wrote. “There are multiple treatment options for Bowen’s disease, of which excision, photodynamic therapy (PDT) and 5-fluorouracil cream are the most commonly prescribed.”

In this multicenter, noninferiority trial, patients with confirmed Bowen’s disease of 4 mm to 40 mm were randomly assigned to receive one of these three treatment options. Clinical outcomes were assessed at follow-up by a supervising dermatologist who was blinded to treatment allocations.

In the excision group, surgical excision was performed with a 5 mm safety margin by the patient’s physician. Those in the 5% 5-fluororacil cream group were instructed to apply a thin layer twice daily for 4 weeks. In the PDT group, patients had a thin layer of MAL-cream applied to the lesion, followed by a light emitting diode for 7.23 minutes. One week later the same process was repeated.

Sustained clearance after 3 months was 97.6% in the excision group, 93.8% in the 5-fluorouracil cream group and 88.8% in the MAL-PDT group.

After 12 months, sustained clearance was 97.4% in the excision group, 85.7% in the 5-fluorouracil group and 82.1% in the MAL-PDT group.

Between 5- fluorouracil and excision, the absolute difference was –11.7%, whereas between MAL-PDT and excision it was –15.4%.

These results demonstrated noninferiority of 5-fluorouracil compared with surgery; however, MAL-PDT noninferiority could not be found.

Cosmetic outcomes, as assessed by two independent observers, found 53.2% of the excision group to have good or excellent results, compared with 81.8% of those treated with 5-fluorouracil and 84.6% of those treated with MAL-PDT. Patient assessment of cosmetic outcomes showed 76% of those who received excision believed their results to be good or excellent, compared with 92.2% of those in the 5-fluorouracil group and 92.3% in the MAL-PDT group.

“The increasing incidence of Bowen’s disease puts a high burden on health care services and treatment costs. Since the costs for in-hospital treatments are much higher than for 5-fluorouracil cream, our results could lead to substantial health care cost reduction. Cost-effectiveness of noninvasive treatments compared to excision needs to be explored in future studies,” the authors wrote. “As 5-fluorouracil is noninferior and associated with better cosmetic outcome than excision, 5-fluorouracil should be preferred over excision and MAL-PDT in treatment of Bowen’s disease.”