Introduction Worldwide surgical excision is the therapy of preference for treatment of basal cell carcinoma. However, in treatment of primary superficial BCC (sBCC), non-invasive techniques (photodynamic therapy (PDT), imiquimod and 5-fluorouracil (5FU) are increasingly used. The goal of this study was to compare the effectiveness and cosmetic outcome of these treatment modalities.
Methods In seven hospitals in The Netherlands, patients were randomly assigned to one of the three groups: PDT, Imiquimod or 5-FU. Stratification by patients’ age and tumour localization was performed. To detect a minimal clinically relevant difference of 10% between compared groups, the planned sample size was 600 patients. The primary outcome was residual or recurrence of carcinoma, diagnosed clinically (by one blinded observer) followed by histological confirmation. Secondary outcome parameters were cosmetic result and side effects. Here, we present the interim results after 18 months of inclusion and a maximum follow up of one year. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN79701845.
Results Between June 2008 and December 2009, 453 patients with 453 sBCC were included. Up till December 2009, 364 patients completed 3 months follow up and 149 patients completed 12 months follow up. Treatment failure at 3 months was observed in 16% (19/118) in the PDT group, 10% (12/121) in the imiquimod group and 8% (10/125) in the 5-FU group. Between 3 and 12 months follow up, treatment failure occurred in 12% (5/42) in the PDT group, 5% (3/56) in the imiquimod group and 6% (3/51) in the 5-FU group. At 3 months follow up, 53% in the 5-FU group had a good or excellent cosmetic result versus 66% and 62% of the lesions in the PDT and imiquimod group, respectively. However during further follow up the cosmetic result after 5-FU treatment strongly improved, with good or excellent cosmetic result in 86% of lesions versus 83% and 74% in the PDT and imiquimod group, respectively. The main side effect of PDT was pain (50%) and burning sensation (80%) experienced by the patients during the illumination part of the treatment. After use of the cremes, burning sensation due to ulceration of the skin, was reported during the second half of the treatment procedure by about 40% of patients.
Conclusion The results of this interim analysis indicate that all three modalities are almost equally effective with a good cosmetic result. Funding source: financed by a grant of The Netherlands Organization for Scientific Research ZONMW (08-82310-98-08626).
Key Words: carcinoma, basal cell, 5-fluorouracil, imiquimod, photodynamic therapy