Clinical Efficacy of 5-Aminolevulinic Acid Photodynamic Therapy in the Treatment of Oral Leukoplakia: A Prospective Study with Long-Term Follow-Up.

PURPOSE: To observe the clinical efficacy and influencing factors of 5-aminolevulinic acid photodynamic therapy (5-ALA-PDT) in treatment oral leukoplakia (OL), so as to provide therapeutic references for clinical application. MATERIALS AND METHODS: After optimizing the 5-ALA-PDT treatment process, 31 OL patients were locally treated with 5- ALA-PDT (wavelength, 635 nm; energy density, 100 J/cm2), with 3 sessions per course of treatment. Efficacy was evaluated one month post-treatment by assessing lesion changes. Additionally, the factors that might influence therapeutic efficacy were analyzed. RESULTS: An overall response rate of 90.3 % was achieved in this study, including 19 patients with complete remission, 9 with partial remission, and 3 with stable disease.The patients were followed for a median of 15 months (95% CI: 9-20 months; range: 3-25 months), during which recurrence occurred in 3 patients and malignant transformation in 2 patients. The treatment effect appeared better for lesions on the ventral tongue than at other sites. Patients who experienced local symptoms such as pain or ulcers after 5-ALA-PDT showed a more favorable response than those without any postoperative reactions. Patients with heterogeneous oral leukoplakia and moderate epithelial dysplasia had a higher recurrence rate than those with homogeneous lesions, simple hyperplasia, or mild epithelial dysplasia, with the peak of recurrence registered at 1-6 months after treatment. CONCLUSION: 5-ALA-PDT appears to be a promising treatment for OL. However, recurrence and malignant transformation remain concerns.