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 eleven 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.

Application of fractal dimension analysis and photodynamic diagnosis in the case of differentiation between lichen planus and leukoplakia: A preliminary study

“…Photodynamic therapy as a noninvasive procedure is more frequently used for the treatment of leukoplakia and LP. [22][23][24][25][26][27] Maloth et al revealed that in their study, in the leukoplakia group, 17% of cases showed a complete response, 66% showed a partial response and 17% of the lesions did not respond to the treatment. In the LP group, 80% of the lesions showed a partial response and 20% did not respond.…”

Development and validation of nomogram for prediction of malignant transformation in oral leukoplakia: A large‐scale cohort study

“…Furthermore, surgical excision appears to decrease the risk of MT, but does not eliminate it . Photodynamic therapy (PDT) with aminolaevulinic acid (ALA) is a non‐surgical method for OL which has shown promising effects in regression of OL . The advantages of PDT are non‐invasiveness, good tolerance, and excellent cosmetic effect .…”

“…20,22 Photodynamic therapy (PDT) with aminolaevulinic acid (ALA) is a non-surgical method for OL which has shown promising effects in regression of OL. 24,25 The advantages of PDT are non-invasiveness, good tolerance, and excellent cosmetic effect. 24 Our study also indicated that PDT therapy has the ability to prevent the malignant progression.…”

Epidemiologic Trends in Head and Neck Cancer and Aids in Diagnosis

“…A new therapeutic approach for treating OED is photodynamic therapy which involves the topical or systemic administration of a photosensitizing agent (i.e. Aminolevulinic acid) that when activated by light causes cytotoxic-cell death by producing reactive oxygen species 49 . Randomized controlled trials are required to determine the effectiveness of photodynamic therapy in treating OED.…”