Efficacy and safety of photodynamic therapy mediatied by 5-aminolevulinic acid for the treatment of cervical intraepithelial neoplasia 3(CIN 3): A single-center, prospective, cohort study

Background: Cervical intraepithelial neoplasia grade 3(CIN 3) is a precancerous lesion condition with high progression rate and is advised to be treated immediately. Because traditional treatments have limited effects or complications, here we evaluated the efficacy and safety of topical 5-aminolevulinic acid (ALA)–based photodynamic therapy (PDT). Methods: This study consisted of 56 female patients diagnosed with CIN3. A 20 % 5-ALA jelly formation was topically applied to the cervix, followed by 635 nm PDT at 7-14 days intervals. Cytology, human papillomavirus (HPV) genotyping, colposcopy, and pathology were assessed after treatment. Results: Among the 56 patients in our study, 26.8 % (15/56) patients had disease remission after just one course PDT, 69.6 % (39/56) patients had partial remission to CIN2, which suggested a response to the therapy and should be treated with more course. The total pathological regression rate was 89.3 %(50/56). Although6 patients did CKC finally, none of the pathology suggest cervical cancer and 2 of them were LSIL. The HPV clearance rate during the 6-month follow-up was 51.8 %. 4 patients had recurrent disease during the 2-year follow-up time point. The most common adverse event was increased vaginal discharge, other side effects include abdominal pain, vulvar pruritus, and vaginal bleeding. No severe adverse effect was observed during the treatment. Conclusion: ALA-PDT is a treatment option for CIN 3 which meet certain conditions, with the main goal to preserve the struction and founction of cervix.