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Photodynamic Therapy of Multiple Nonmelanoma Skin Cancers With Verteporfin and Red Light–Emitting Diodes
Two-Year Results Evaluating Tumor Response and Cosmetic Outcomes
Harvey Lui, MD;
Lori Hobbs, MD;
Whitney D. Tope, MPhil, MD;
Peter K. Lee, MD, PhD;
Craig Elmets, MD;
Nathalie Provost, MD;
Agnes Chan, PhD;
Herma Neyndorff;
Xiang Yao Su, PhD;
Hem Jain, MD;
Iltefat Hamzavi, MD;
David McLean, MD;
Robert Bissonnette, MD
Arch Dermatol. 2004;140:26-32.
Background Efficient treatment of patients with multiple synchronous nonmelanoma skin cancers represents a therapeutic challenge.
Objective To study the safety and efficacy of photodynamic therapy (PDT) with verteporfin and red light in the treatment of multiple nonmelanoma skin cancers.
Design Open-label, randomized, multicenter, dose-ranging phase 2 study conducted at 4 North American university-based dermatology clinics.
Patients Fifty-four patients with 421 multiple nonmelanoma skin cancers including superficial and nodular basal cell carcinoma and squamous cell carcinoma in situ (Bowen disease).
Methods A single intravenous infusion of 14 mg/m2 of verteporfin followed 1 to 3 hours later by exposure of tumors to 60, 120, or 180 J/cm2 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. Clinical and cosmetic responses were assessed and graded at 6 weeks, 3 months, and 6 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 biopsy specimens 6 months after verteporfin PDT, ranged from 69% at 60 J/cm2 to 93% at 180 J/cm2. At 24 months of follow-up (276 tumors in 31 patients), the clinical complete response rate ranged from 51% at 60 J/cm2 to 95% at 180 J/cm2. No significant systemic adverse events were observed; most events occurred at the treated tumor sites and included 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 patients with multiple nonmelanoma skin cancers.
From the Division of Dermatology, University of British Columbia and Vancouver General Hospital, Vancouver (Drs Lui, Hobbs, Jain, Hamzavi, and McLean); Department of Dermatology, University of Minnesota, Minneapolis (Drs Tope and Lee); Department of Dermatology, University of Alabama, Birmingham (Dr Elmets); Division of Dermatology, University of Montreal Hospital Centre, Montreal, Quebec (Drs Provost and Bissonnette); and QLT Inc, Vancouver, British Columbia (Drs Chan and Su and Ms Neyndorff). Drs Lui, McLean, and Bissonnette have served as paid consultants for QLT Inc, Vancouver, British Columbia. Dr Tope was paid by QLT to attend investigators' meetings and to testify for QLT at the US Food and Drug administration on the present data. Drs Chan and Su and Ms Neyndorff are employees of QLT and hold stock and/or stock options in the company. Dr Hamzavi received funds from QLT for travel expenses to an investigators' meeting and to conduct a phase 3 trial related to data in this study.
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