A randomized study of hexaminolevulinate photodynamic therapy in patients with cervical intraepithelial neoplasia 1/2
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
25467012
DOI
10.1016/j.ajog.2014.10.1107
PII: S0002-9378(14)02199-1
Knihovny.cz E-resources
- Keywords
- cervical intraepithelial neoplasia, hexaminolevulinate, human papillomavirus, photodynamic therapy,
- MeSH
- Intention to Treat Analysis MeSH
- Administration, Topical MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Uterine Cervical Dysplasia drug therapy pathology MeSH
- Photochemotherapy * MeSH
- Photosensitizing Agents therapeutic use MeSH
- Aminolevulinic Acid analogs & derivatives therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Uterine Cervical Neoplasms drug therapy pathology MeSH
- Drug Administration Schedule MeSH
- Treatment Outcome MeSH
- Dose-Response Relationship, Drug MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- 5-aminolevulinic acid hexyl ester MeSH Browser
- Photosensitizing Agents MeSH
- Aminolevulinic Acid MeSH
OBJECTIVE: The objective of the study was to investigate the efficacy and safety of hexaminolevulinate (HAL) photodynamic therapy (PDT), a novel therapy for women with cervical intraepithelial neoplasia (CIN)1/2, to define the appropriate population and endpoints for a phase 3 program. STUDY DESIGN: This was a double-blind, randomized, placebo-controlled, dose-finding study that included a total of 262 women with biopsy-confirmed CIN 1/2 based on local pathology. Patients received 1 or 2 topical treatments of HAL hydrochloride 0.2%, 1%, 5%, and placebo ointment and were evaluated for response after 3-6 months based on biopsy, Papanicolaou test, and oncogenic human papillomavirus (HPV) test. All efficacy analyses were performed on blinded central histology review to avoid interreader variability. Adverse events, blood biochemistry, and vital signs were assessed after 3 months. RESULTS: There were no statistically significant differences between placebo and either the CIN 1 or combined CIN 1/2 populations. A clear dose effect with a statistically significant response in the HAL 5% group of 95% (18/19 patients) compared to 57% (12/21 patients) in the placebo group (P < .001) was observed at 3 months in women with CIN 2, including an encouraging 83% (5/6 patients) clearance of HPV 16/18 compared to 33% (2/6 patients) in the placebo group at 6 months. The treatment was easy to use and well accepted by patients and gynecologists. Only local self-limiting adverse reactions including discharge, discomfort, and spotting were reported. CONCLUSION: HAL PDT is a novel therapy that shows promise in the treatment of CIN 2 including clearance of oncogenic HPV, but not of CIN 1. The positive risk/benefit balance makes HAL PDT a tissue-preserving alternative in women of childbearing age who wish to preserve the cervix. Confirmatory studies are planned.
Center of Excellence in Women's Health University of Arizona Tucson AZ
Center of Outpatient Gynecology Clinic and Primary Care Brno Czech Republic
Department of Obstetrics and Gynecology Hannover Medical School Hannover Germany
References provided by Crossref.org
ClinicalTrials.gov
NCT01256424