Photodynamic therapy with HiPorfin for cervical squamous intraepithelial lesion at childbearing age

Objective: To evaluate the clinical efficacy and safety of HiPorfin (R) photodynamic therapy (PDT) in the treatment of young women at reproductive age with high-grade squamous intraepithelial lesion (HSIL) of the cervix. Methods: Prospective study of 41 patients aged 28.8 +/- 4.6 years old with cervical intraepithelial neoplasia (CIN) II-III at Peking University Shenzhen Hospital from March 2019 to January 2023. HiPorfin (R) (2 mg/kg) was infused intravenously, and 48-72 h later, 630-nm laser irradiation was performed in cervical canal and cervical surface with an irradiation dose of 100-120 J/cm2 and 150 J/cm2 respectively. Results: All 41 patients with no recurrence had been observed at least 12 months follow-up period after PDT. The number of nulliparous women was 30 (30/41, 73.2 %). CIN II were 22 cases (22/41,53.7 %) and CIN III were 19 cases (19/41,46.3 %). Complete response (CR) was in 95.5 % (21/22) patients with CIN II and 78.9 % (15/19) patients with CIN III at 6 months follow-up. Meanwhile, CR rate was 100.0 % (22/22) and 84.2 % (16/19) in CIN II and CIN III group respectively at 12 months. Pre-treatment, all patients (41/41,100 %) were Human papilloma virus (HPV) positive. HPV eradication rate was 63.4 % (26/41), 73.2 % (30/41) and 92.7 % (38/41) at 3, 6 and 12 months after PDT respectively. Before treatment, cytology >= atypical squamous cells of undetermined significance (ASCUS) was 78.0 % (32/41). Negative conversion ratio of cytology was 75.0 % (24/32), 90.6 % (29/ 32) and 100.0 % (32/32) at 3, 6 and 12 months after PDT respectively. There were no serious adverse effects in patients during and after PDT. Conclusion: HiPorfin-PDT is a promising and organ-saving approach for cervical HSIL, which also eradicates HPV infection effectively and can be a beacon of hope for the young women with fertility preservation requirement.