Photodynamic therapy versus topical imiquimod versus topical fluorouracil for treatment of superficial basal-cell carcinoma: a single blind, non-inferiority, randomised controlled trial: a critical appraisal

AIM: Arits et al. aimed to assess whether the effectiveness of imiquimod and fluorouracil is not inferior to methyl aminolaevulinic acid (MAL) photodynamic therapy (PDT) in patients with superficial basal cell carcinoma. SETTING AND DESIGN: This single-blind, noninferiority, randomized controlled trial was conducted at one coordinating academic hospital and six peripheral dermatological departments in the Netherlands between March 2008 and August 2010. STUDY EXPOSURE: Patients with a superficial basal cell carcinoma were randomly assigned to be treated with PDT (two treatments); or imiquimod 5% cream, once daily five times a week for 6 weeks; or fluorouracil 5% cream twice daily for 4 weeks. Follow-up visits were planned after 3 months and 1 year. OUTCOMES: The primary outcome was defined as the probability that a patient was free of tumour reoccurrence at both 3 and 12 months' follow-up. Secondary outcomes were aesthetic outcome of the treated area, compliance and adverse reactions. RESULTS: In total 911 patients were assessed for eligibility, of whom 601 were randomized: 202 to receive MAL-PDT, 198 to receive imiquimod cream and 201 to receive fluorouracil cream. The proportions (95% confidence intervals) of patients tumour free at both 3 and 12 months were 72·8% (66·8-79·4) for MAL-PDT, 83·4% (78·2-88·9) for imiquimod cream and 80·1% (74·7-85·9) for fluorouracil cream. For patients treated with MAL-PDT, moderate-to-severe pain and burning sensation were reported most often during the treatment itself. For the creams, moderate-to-severe local swelling, erosion, crust formation and itching of the skin were mentioned most often. CONCLUSIONS: Arits et al. conclude that topical fluorouracil was noninferior and imiquimod was superior to MAL-PDT for treatment of superficial basal cell carcinoma. Imiquimod cream is suggested as the preferred treatment.