ArticlesPhotodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial
Introduction
Basal-cell carcinoma is the most common form of skin cancer and is an important health problem worldwide, with a rapidly increasing incidence and health care costs.1, 2, 3 Although there are many histological subtypes, a simplified classification (Rippey) groups all basal-cell carcinomas into three histological subtypes: superficial, nodular, and infiltrative.4 A third of all basal-cell carcinomas are of the superficial subtype,5 which often appear on the trunk and resemble an eczema-like plaque. Because of the growing incidence in basal-cell carcinomas worldwide, a non-surgical treatment is often chosen for the superficial disease, since this subtype is easily accessible with topical treatment. An international consensus6 on the use of photodynamic therapy in non-melanoma skin cancer recommended it as first-line treatment for superficial basal-cell carcinoma.6 Photodynamic therapy is based on the activation of a topical applied photosensitiser by illumination of the skin lesion with light of an appropriate wavelength to destroy tumour cells. However, both fluorouracil cream and imiquimod cream can be considered as an alternative treatment.7 We assessed the effectiveness of imiquimod and fluorouracil cream versus photodynamic therapy for treatment of superficial basal-cell carcinoma.
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Patients
Patients with a primary, histologically proven superficial basal-cell carcinoma were eligible to participate. Histology of the lesion was obtained by a 3 mm punch biopsy and was assessed by various dermatopathologists at the participating hospitals until a consensus on the definition of a superficial basal-cell carcinoma was reached. It was defined as an epidermal tumour existing of small, discrete islands of basaloid cells with peripheral palisading and stromal retraction, presenting
Results
Between March 1, 2008, and Aug 31, 2010, 601 patients with superficial basal-cell carcinoma were randomly assigned to treatment with MAL-PDT (n=202), topical imiquimod (n=198), or topical fluorouracil (n=201). Patient and tumour characteristics were similar between groups (table 1). 11 patients did not begin treatment and seven patients were treated but did not attend the first follow-up visit at 3 months. Data for relevant endpoints were not available for these patients. The remaining 583
Discussion
Topical fluorouracil was non-inferior to, and imiquimod was superior to, MAL-PTD in terms of treatment success after 1 year of follow-up. These results suggest that topical imiquimod should be the first choice for treatment of superficial basal-cell carcinoma.
This is the first randomised controlled trial that we know of that has compared the effectiveness of imiquimod, fluorouracil, and photodynamic therapy for treatment of superficial basal-cell carcinoma. Previously published studies on the
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