Smoking Impacts Photodynamic Therapy Success In Oral Leukoplakia

To evaluate the influence of smoking status on the therapeutic efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) for oral leukoplakia (OLK). In this prospective, open-label, controlled clinical trial, 60 OLK patients receiving ≥1 ALA-PDT treatment at Nanjing University School of Stomatology (June 2021-September 2024) were stratified into three groups: non-smokers (n=30), active smokers (n=17), and smoking quitters (n=13). Treatment protocol involved biweekly ALA-PDT sessions (635 nm, 100 J/cm²) until lesion resolution/stabilization. Clinical outcomes were assessed through: 1) Lesion area reduction at 4-week post-treatment, 2) Recurrence rates during ≥3-month follow-up (median 8.57±5.34 months), and 3) Malignant transformation. Standardized follow-ups occurred at 2 weeks, 1, 3, and 6 months post-treatment, with subsequent 3-6 month intervals. Four-week response rates significantly differed across groups (p=0.0419): non-smokers 86.67% (26/30), active smokers 88.24% (15/17), and quitters 76.92% (10/13). Longitudinal analysis revealed differential recurrence patterns: non-smokers 3.3% (1/30) vs smokers 11.8% (2/17) vs quitters 23.1% (3/13), though without statistical significance (p=0.0625). No malignant transformations were observed. Treatment-related adverse events were limited to transient mucosal erythema (28.3%) and mild pain (16.7%). Smoking status significantly affects short-term clinical outcomes of ALA-PDT in OLK management, with active smokers paradoxically showing superior initial response rates compared to cessation patients.