Abstract | BACKGROUND AND OBJECTIVES: STUDY DESIGNS/MATERIALS AND METHODS: Forty women, who were at least 18 years old with persistent biopsy-proven CIN 2 and CIN 3 within the previous 3 months of enrollment, underwent PDT in a phase I and II design. Five escalating radiant energies (increments of 25 J/cm(2), beginning at 50-150 J/cm(2)) using a Coherent Dye Model 920 argon pumped dye laser providing light at 630 nm (maximum output 0.8 W) were used to perform PDT with a fixed dose of ALA (200 mg/ml). ALA was placed in a cervical cap fitted to the cervix. After 90 minutes, the cap was removed and the ectocervix was illuminated for 5-16 minutes, depending on the irradiance. Success was defined as the absence of CIN on Pap smear or colposcopic examination at 12-months. Patients were monitored for toxicity. RESULTS: Thirty-two women (80%) completed the study with 1 year of follow-up. Sixty percent had CIN 3 and 40% CIN 2. Success rates at 4, 8, and 12 months were 51, 46, and 31%, respectively, and were not light-dose dependent. Three patients progressed from CIN 2 to CIN 3. Toxicity was tolerable and only consisted of spotting, vaginal discharge, mild cramping, and vaginal warmth. There was no apparent dose relationship to toxicity. CONCLUSIONS:
PDT at this light and ALA dose is well tolerated but has minimal activity in the treatment of CIN 2 and CIN 3. Other doses and schedules of light and ALA or novel photosensitizers may improve efficacy.
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Authors | Kristin A Keefe, Yona Tadir, Bruce Tromberg, Michael Berns, Kathryn Osann, Rasha Hashad, Bradley J Monk |
Journal | Lasers in surgery and medicine
(Lasers Surg Med)
Vol. 31
Issue 4
Pg. 289-93
( 2002)
ISSN: 0196-8092 [Print] United States |
PMID | 12355576
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)
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Copyright | Copyright 2002 Wiley-Liss, Inc. |
Chemical References |
- Photosensitizing Agents
- Aminolevulinic Acid
|
Topics |
- Adult
- Aminolevulinic Acid
(adverse effects, therapeutic use)
- Female
- Follow-Up Studies
- Humans
- Outcome Assessment, Health Care
- Photochemotherapy
(adverse effects)
- Photosensitizing Agents
(adverse effects, therapeutic use)
- Severity of Illness Index
- Time Factors
- Uterine Cervical Neoplasms
(drug therapy, pathology)
- Uterine Cervical Dysplasia
(drug therapy, pathology)
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