Efficacy and safety of hexaminolevulinate photodynamic therapy in patients with low‐grade cervical intraepithelial neoplasia

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. Lasers Surg. Med. 46:456–461, 2014. © 2014 Wiley Periodicals, Inc.