A dose ranging study of photodynamic therapy with porfimer sodium (Photofrin®) for treatment of basal cell carcinoma

Background and Objectives: While basal cell carcinoma (BCC) is effectively treated by several methods, many patients with numerous or frequently occurring lesions seek alternatives that can treat multiple cancers, with improved cosmetic outcome. PDT for esophageal and lung carcinomas is approved at a porfimer sodium (Photofrin®) dose of 2 mg/kg, but lower doses increase selectivity and decrease both cutaneous phototoxicity and cost. We evaluated low doses of porfimer sodium PDT for treatment of multiple BCC. Materials and Methods: Seventy-seven patients with 2,041 BCC were injected with 0.75, 0.875, or 1.0 mg/kg porfimer sodium and treated 2 days later with 630-nm light. Clinical responses were determined at 6 months, then periodically to 5 years. Results: Increasing porfimer sodium dose increased complete responses (CR), with initial CR rates of 72.7% (66-78%, 95% CI), 79.9% (73-86%, 95% CI), and 92.2% (91-93%, 95% CI), albeit with some lower selectivity at the highest dose. At 1 mg/kg, 5-year recurrence rates were 28% (21-35%, 95% CI) and 15% (11-18%, 95% CI) for sporadic and nevoid basal cell carcinoma syndrome (NBCCS) lesions, respectively. Conclusions: This is the largest dose-ranging study of porfimer sodium, and the largest number of lesions treated in a single study. We found that with 1 mg/kg porfimer sodium, PDT can be a selective and durable treatment for sporadic and NBCCS-associated BCC. Lasers Surg.