Comparison of photodynamic therapy and LEEP in women of reproductive age with cervical squamous intraepithelial neoplasia 2 (CIN2): A prospective observational study in China.

Abstract

Background: Non-invasive treatments, such as 5-Aminolevulinic acid photodynamic therapy (5-ALA-PDT), has gained increasing attention among women with cervical intraepithelial neoplasia grade 2 (CIN2) who have fertility requirements. To compare the effectiveness of 5-ALA-PDT and loop electrosurgical excision procedure (LEEP) in patients with CIN2, we conducted this prospective cohort study in Chinese patients with CIN2.

Methods: 229 patients with CIN2 were enrolled. They were divided into the PDT Group (n=94) and LEEP Group (n=135) according to the patient's willingness. Patients were evaluated at the 3-, 6-, 12- and 18-month follow-up periods, using cytology, HPV testing, and colposcopy examination.

Results: At the 3-month follow-up, the rates of disease regression to normal or CIN1 in the PDT group were 76.6% (72/94) and 13.8% (13/94), respectively, whereas in the LEEP group, they were 80.7% (109/135) and 11.1% (15/135), respectively. Logistic regression analysis revealed that the transformation zone type 3 was the only risk factor for both the PDT (OR=3.68; 95% CI, 2.43-5.26; P=0.008) and LEEP groups (OR=2.34; 95% CI, 1.84-4.53; P=0.02). The treatment efficacy in the PDT group increased gradually and peaked at the 18-month follow-up point with disease disappearance and regression rates of 90.4% and 8.5%, respectively. The disease disappearance and regression rates in the LEEP group were highest at the first half year posttreatment, with disease disappearance and regression rates of 87.4% and 12.6%, respectively. The hrHPV-negative rates in the PDT group and LEEP group were the highest at the 18-month follow-up (78.7% and 74.8%). There was no significant difference in the disappearance or regression rates between the two groups at the follow-up points (P > 0.05).

Conclusions: Our study revealed that both 5-ALA PDT therapy and LEEP were highly effective at treating CIN2. 5-ALA-PDT, as a non-invasive treatment, could be an effective option for CIN2 patients with fertility preservation needs.