A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia

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; Alexander Dew; Peter Kulesza; Vamsi Parimi; Raymond C. Bergan; Eva Szabo

doi:10.1016/j.oraloncology.2013.05.011

A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia

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, Alexander Dew, Peter Kulesza, Vamsi Parimi, Raymond C. Bergan, Eva Szabo

Research output: Contribution to journal › Article › peer-review

26 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	970-976
Number of pages	7
Journal	Oral Oncology
Volume	49
Issue number	9
DOIs	https://doi.org/10.1016/j.oraloncology.2013.05.011
State	Published - Sep 2013
Externally published	Yes

Keywords

Aminolevulinic acid
I
Laser
Leukoplakia
Phase
Photodynamic therapy

ASJC Scopus subject areas

Oral Surgery
Oncology
Cancer Research

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10.1016/j.oraloncology.2013.05.011

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Wong, S. J., Campbell, B., Massey, B., Lynch, D. P., Cohen, E. E. W., Blair, E., Selle, R., Shklovskaya, J., Jovanovic, B. D., Skripkauskas, S., Dew, A., Kulesza, P., Parimi, V., Bergan, R. C., & Szabo, E. (2013). A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia. Oral Oncology, 49(9), 970-976. https://doi.org/10.1016/j.oraloncology.2013.05.011

Wong, SJ, Campbell, B, Massey, B, Lynch, DP, Cohen, EEW, Blair, E, Selle, R, Shklovskaya, J, Jovanovic, BD, Skripkauskas, S, Dew, A, Kulesza, P, Parimi, V, Bergan, RC & Szabo, E 2013, 'A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia', Oral Oncology, vol. 49, no. 9, pp. 970-976. https://doi.org/10.1016/j.oraloncology.2013.05.011

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title = "A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia",

abstract = "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.",

keywords = "Aminolevulinic acid, I, Laser, Leukoplakia, Phase, Photodynamic therapy",

author = "Wong, {Stuart J.} and Bruce Campbell and Becky Massey and Lynch, {Denis P.} and Cohen, {Ezra E.W.} and Elizabeth Blair and Rebecca Selle and Julia Shklovskaya and Jovanovic, {Borko D.} and Silvia Skripkauskas and Alexander Dew and Peter Kulesza and Vamsi Parimi and Bergan, {Raymond C.} and Eva Szabo",

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doi = "10.1016/j.oraloncology.2013.05.011",

language = "English (US)",

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T1 - A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia

AU - Wong, Stuart J.

AU - Campbell, Bruce

AU - Massey, Becky

AU - Lynch, Denis P.

AU - Cohen, Ezra E.W.

AU - Blair, Elizabeth

AU - Selle, Rebecca

AU - Shklovskaya, Julia

AU - Jovanovic, Borko D.

AU - Skripkauskas, Silvia

AU - Dew, Alexander

AU - Kulesza, Peter

AU - Parimi, Vamsi

AU - Bergan, Raymond C.

AU - Szabo, Eva

PY - 2013/9

Y1 - 2013/9

N2 - 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.

AB - 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.

KW - Aminolevulinic acid

KW - I

KW - Laser

KW - Leukoplakia

KW - Phase

KW - Photodynamic therapy

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A phase i trial of aminolevulinic acid-photodynamic therapy for treatment of oral leukoplakia

Abstract

Keywords

ASJC Scopus subject areas

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