Photodynamic Therapy of Multiple Nonmelanoma Skin Cancers With Verteporfin and Red Light-Emitting Diodes Two-Year Results Evaluating Tumor Response and Cosmetic Outcomes

Background Efficient treatment of patients with multiple synchronous nonmelanomaskin cancers represents a therapeutic challenge. Objective To study the safety and efficacy of photodynamic therapy (PDT) withverteporfin and red light in the treatment of multiple nonmelanoma skin cancers. Design Open-label, randomized, multicenter, dose-ranging phase 2 study conductedat 4 North American university-based dermatology clinics. Patients Fifty-four patients with 421 multiple nonmelanoma skin cancers includingsuperficial and nodular basal cell carcinoma and squamous cell carcinoma insitu (Bowen disease). Methods A single intravenous infusion of 14 mg/m 2 of verteporfinfollowed 1 to 3 hours later by exposure of tumors to 60, 120, or 180 J/cm 2 of red light (688 ± 10 nm) from a light-emitting diode panel. Main Outcome Measures Pathologic response of treated sites was assessed at 6 months. Clinicaland cosmetic responses were assessed and graded at 6 weeks, 3 months, and6 months after verteporfin PDT, with optional follow-up visits at 12, 18,and 24 months. Results The histopathologic response, defined as absence of tumor on biopsyspecimens 6 months after verteporfin PDT, ranged from 69% at 60 J/cm 2 to 93% at 180 J/cm 2 . At 24 months of follow-up (276 tumorsin 31 patients), the clinical complete response rate ranged from 51% at 60J/cm 2 to 95% at 180 J/cm 2 . No significant systemic adverseevents were observed; most events occurred at the treated tumor sites andincluded events such as pain. Overall, 65% (95% confidence interval, 58%-71%)of tumors were judged to have good to excellent cosmesis at 24 months. Conclusion A single course of verteporfin PDT showed treatment benefit for patientswith multiple nonmelanoma skin cancers.