Skin cancer can return after treatment, leaving patients worried about what works best. This trial compared surgery against two light-based therapies for Bowen's disease. The researchers tracked 250 patients across multiple centers to see who stayed cancer-free the longest. Four years after treatment, surgery kept 97.5 percent of patients tumor-free. The two light-based options, using 5-fluorouracil and methylaminolevulinate, showed lower success rates at 86.2 percent and 82.7 percent respectively. The study also looked at the risk of developing a new, more serious skin cancer called cutaneous squamous cell carcinoma. None of the patients developed this new cancer in the treated area. One patient did have their cancer come back five years after the light treatment. The researchers noted that 23.2 percent of patients were lost to follow-up. This means some data might be missing, which adds uncertainty to the long-term picture. Despite this gap, the results clearly show surgery remained the most reliable option for keeping the skin clear of tumors.
5-Fluorouracil and MAL-PDT vs Surgery for Bowen's Disease: 4-Year OutcomesSurgery kept skin cancer away better than two light-based treatments in this trial
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Key Takeaway
Consider surgical excision as first-line for Bowen's disease; 5FU and MAL-PDT are less effective but viable alternatives.
This multicenter randomized controlled trial included 250 patients with Bowen's disease and compared three treatments: 5-fluorouracil, methylaminolevulinate photodynamic therapy (MAL-PDT), and surgical excision (SE). The primary outcome was the cumulative probability of tumor-free survival at 4 years post-treatment.
At 4 years, the cumulative probability of tumor-free survival was 97.5% for SE (95% CI: 90.4-99.4), 86.2% for 5FU (95% CI: 76.4-92.1), and 82.7% for MAL-PDT (95% CI: 72.6-89.4). During the first year of follow-up, 27 patients experienced treatment failure. One additional patient developed a recurrence 5 years after MAL-PDT. No patient developed a cutaneous squamous cell carcinoma (cSCC) in the treated area.
Safety and tolerability data were not reported in detail. A key limitation was loss to follow-up in 23.2% of patients, which may affect the reliability of long-term outcomes.
For clinical practice, surgical excision remains the most effective treatment for Bowen's disease based on these 4-year data. However, 5-fluorouracil and MAL-PDT are reasonable alternatives for patients who are not surgical candidates, with slightly lower tumor-free survival rates.
What this means for you:
Surgery provided the best four-year tumor-free survival rate compared to light-based treatments. More on Bowen's disease
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View Original Abstract ↓
BACKGROUND: Evidence on long-term efficacy with head-to-head comparison of different treatments for Bowen's disease (BD) is lacking.
OBJECTIVE: To compare the long-term efficacy of 5-fluorouracil and methylaminolevulinate photodynamic therapy (MAL-PDT) versus surgical excision (SE) in BD.
METHODS: In this multicenter, non-inferiority randomized controlled trial, 250 patients with BD were invited for long-term follow-up, 3 to 5 years post-treatment. Patients had been randomly assigned to 5FU, MAL-PDT, or SE in a 1:1:1-ratio. The primary outcome was the cumulative probability of tumor-free survival 4 years post-treatment with treatment failures confirmed histopathologically. A secondary endpoint was the risk of cutaneous squamous cell carcinoma (cSCC).
RESULTS: During the first year of follow-up, treatment failure was observed in 27 patients. During long-term follow-up, only 1 additional patient developed a recurrence, 5 years after MAL-PDT. The 4-year cumulative probability of tumor-free survival was 97.5% for SE (95% confidence interval (CI) 90.4-99.4), 86.2% for 5FU (95% CI 76.4-92.1), and 82.7% for MAL-PDT (95% CI 72.6-89.4). No patient developed a cSCC in the treated area.
LIMITATIONS: Loss to follow-up occurred in 23.2% of patients.
CONCLUSIONS: During long-term follow-up, the additional risk of recurrence of BD after 5FU and SE, and the risk of developing a cSCC from a treated BD were negligible. Treatment with 5FU remains non-inferior to SE, whereas non-inferiority of MAL-PDT could not be concluded.
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