2014/05/06 by Peter Hillemanns, Karl Ulrich Petry, Karl‐Ulrich Petry +6
Medicine · #Adverse effect #Cancer #Cervical Cancer and HPV Research #Cervical cancer #Cervical intraepithelial neoplasia #Colposcopy #Gastroenterology #Head and Neck Cancer Studies #Internal medicine #Medicine #Pathology #Photodynamic Therapy Research Studies #Photodynamic therapy #Placebo #Population #Randomized controlled trial #Suppository #Surgery
paper · doi:10.1002/lsm.22255
crossref issued 2014/05/06 · crossref published 2014/05/06 · crossref published-online 2014/05/06 · openalex publication_date 2014/05/06 · crossref created 2014/05/06 · crossref published-print 2014/08/01 · crossref deposited 2023/10/03 · openalex created_date 2025/10/10 · crossref indexed 2026/08/06 · openalex updated_date 2026/08/06
OBJECTIVE: Non-surgical therapies are needed to reduce the rate of progression of low-grade cervical intraepithelial neoplasia (CIN 1) to high grade CIN (CIN 2/3). The aim of this study was to assess the efficacy and safety of hexaminolevulinate (HAL) photodynamic therapy (PDT) in the treatment of patients with CIN 1. STUDY DESIGN: This phase IIa prospective double-blind study randomized patients with CIN 1 into three groups: HAL vaginal suppository, placebo vaginal suppository or follow-up only. Patients in the first two groups received HAL or placebo suppositories 5 hours before illumination with 50 J/cm(2) red coherent light (633 nm) using a special light catheter. All patients had a follow up including colposcopy, cytology and human papilloma virus (HPV) testing 3 and 6 months and additional biopsy 6 months after PDT. The main outcome measure was efficacy, defined as complete histologic remission 6 months after PDT. Secondary outcomes were histologic remission 3 months and HPV eradication 6 months after first PDT. RESULTS: Seventy patients were randomized: 47 to HAL, 12 to placebo, 11 to follow up only. After 6 months CIN lesions had cleared in 57% of patients in the HAL-PDT group compared to 25% in the combined control group (per protocol population, P = 0.04). Twenty-six patients (37%) reported 44 adverse events (AEs), of which 40 were mild or moderate. Nineteen treatment-related AEs were reported by 15 patients (32%) in the HAL PDT group, one in the placebo PDT group (8%), and none in the follow-up group. The most common adverse events were local discomfort including mild pain/cramping (11) and leucorrhoea (2). CONCLUSION: HAL PDT shows a favorable efficacy and safety profile and represents a promising alternative to observation and surgical procedures in patients with CIN 1.