PMID- 24799181
OWN - NLM
STAT- MEDLINE
DCOM- 20150413
LR  - 20221207
IS  - 1096-9101 (Electronic)
IS  - 0196-8092 (Linking)
VI  - 46
IP  - 6
DP  - 2014 Aug
TI  - Efficacy and safety of hexaminolevulinate photodynamic therapy in patients with 
      low-grade cervical intraepithelial neoplasia.
PG  - 456-61
LID - 10.1002/lsm.22255 [doi]
AB  - 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.
CI  - (c) 2014 Wiley Periodicals, Inc.
FAU - Hillemanns, Peter
AU  - Hillemanns P
AD  - Department of Obstetrics and Gynecology, Hannover Medical School, Hannover, 
      Germany.
FAU - Petry, Karl-Ulrich
AU  - Petry KU
FAU - Soergel, Philipp
AU  - Soergel P
FAU - Collinet, Pierre
AU  - Collinet P
FAU - Ardaens, Katty
AU  - Ardaens K
FAU - Gallwas, Julia
AU  - Gallwas J
FAU - Luyten, Alexander
AU  - Luyten A
FAU - Dannecker, Christian
AU  - Dannecker C
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20140506
PL  - United States
TA  - Lasers Surg Med
JT  - Lasers in surgery and medicine
JID - 8007168
RN  - 0 (Photosensitizing Agents)
RN  - 0 (Suppositories)
RN  - 88755TAZ87 (Aminolevulinic Acid)
SB  - IM
MH  - Adult
MH  - Aminolevulinic Acid/*therapeutic use
MH  - Biopsy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Photochemotherapy/*methods
MH  - Photosensitizing Agents/*therapeutic use
MH  - Prospective Studies
MH  - Suppositories
MH  - Treatment Outcome
MH  - Vagina
MH  - Uterine Cervical Dysplasia/*drug therapy
OTO - NOTNLM
OT  - CIN
OT  - HPV
OT  - cervical cancer
OT  - hexaminolevulinate
OT  - photodynamic therapy
EDAT- 2014/05/07 06:00
MHDA- 2015/04/14 06:00
CRDT- 2014/05/07 06:00
PHST- 2014/04/02 00:00 [accepted]
PHST- 2014/05/07 06:00 [entrez]
PHST- 2014/05/07 06:00 [pubmed]
PHST- 2015/04/14 06:00 [medline]
AID - 10.1002/lsm.22255 [doi]
PST - ppublish
SO  - Lasers Surg Med. 2014 Aug;46(6):456-61. doi: 10.1002/lsm.22255. Epub 2014 May 6.