Photodynamic therapy of vulvar intraepithelial neoplasia III using topically applied 5-aminolevulinic acid

Objectives. The aim of this study was twofold: first, to determine the feasibility of photodynamic therapy (PDT) of vulvar intraepithelial neoplasia III (VIN III) using topically applied 5-aminole-vulinic acid (ALA) for photosensitization, and second, to compare PDT results with those of laser evaporation and local excision. Methods. Fifteen patients with VIN III had 10 g of 10% ALA gel applied to the entire vulva. Two to three hours after drug application the vulva was irradiated with 120 J/cm(2) laser light at a wavelength of 635 nm. The procedure was performed without anesthesia in most patients. Thirty patients with VIN III treated by laser evaporation and 27 patients treated by surgical excision served as controls. Results. Eight weeks following PDT, 11 of 15 patients were free of VIN III as determined by biopsy. Excellent tissue preservation was achieved and no ulcers or scarring occurred. Three recurrences were seen during follow-up, at 5, 6, and 7 months after PDT. Twelve months after treatment, analysis of disease-free survival revealed no statistically significant difference between patients treated with PDT and patients treated with conventional treatment modalities (P = 0.67) but the power of this analysis is low, In multivariate analysis, multifocal disease was the sole variable associated with a reduced disease-free survival. Conclusion. While PDT of VIN III seems to show efficacy similar to that of conventional treatment modalities it offers unique advantages: healing time is short, preservation of normal vulvar appearance is excellent, and PDT may be performed without anesthesia. Hence, PDT of VIN III deserves further investigation. (C) 2001 Academic Press.