- 作者：Stuart J. Wong ; Bruce Campbell ; Becky Massey ; Denis P. Lynch ; Ezra E.W. Cohen ; Elizabeth Blair ; Rebecca Selle ; Julia Shklovskaya ; Borko D. Jovanovic ; Silvia Skripkauskas ; Alex ; er Dew ; Peter Kulesza ; Vamsi Parimi ; Raymond C. Bergan ; Eva Szabo
- 关键词：Leukoplakia ; Aminolevulinic acid ; Photodynamic therapy ; Phase I ; Laser
- 刊名：Oral Oncology
- 出版年：2013
- 出版时间：September, 2013
- 年：2013
- 卷：49
- 期：9
- 页码：970-976
- 全文大小：641 K
Summary
Background
Photodynamic therapy with aminolevulinic acid (ALA PDT) for oral leukoplakia has shown promising effects in regression of oral leukoplakia. Although ALA has been extensively studied and is an ideal photosensitizer, the optimal light dose for treatment of oral leukoplakia has not been determined. We conducted a phase I study to determine MTD and DLT of PDT in patients treated with ALA for leukoplakia.Methods
Patients with histologically confirmed oral leukoplakia received a single treatment of ALA PDT in cohorts with escalating doses of light (585 nm). Clinical, histologic, and biologic markers were assessed.
Results
Analysis of 11 participants is reported. No significant toxicity from ALA PDT was observed in patients who received ALA with a light dose of up to 4 J/cm2. One participant experienced transient grade 3 transaminase elevation due to ALA. One participant had a partial clinical response 3 months after treatment. Biologic mucosal risk markers showed no significant associations. Determination of MTD could not be accomplished within a feasible timeframe for completion of the study.
Conclusions
ALA PDT could be safely administered with a light dose up to 4 J/cm2 and demonstrated activity. Larger studies are needed to fully elucidate the MTD and efficacy of ALA-PDT.