Abstract
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. Patients with histologically confirmed oral leukoplakia received a single treatment of ALA PDT in cohorts with escalating doses of light (585nm). Clinical, histologic, and biologic markers were assessed. 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 4J/cm(2). One participant experienced transient grade 3 transaminase elevation due to ALA. One participant had a partial clinical response 3months 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. ALA PDT could be safely administered with a light dose up to 4J/cm(2) and demonstrated activity. Larger studies are needed to fully elucidate the MTD and efficacy of ALA-PDT.
Highlights
Each year in the United States over 40,000 new cases of head and neck squamous cell cancer (HNSCC) are diagnosed, with approximately 27,000 of these cases occurring in the oral cavity or pharynx. 1 Oral cavity cancer is associated with a poor prognosis with 5 year survival rates of less than 50%. 1 While incremental advances have been achieved in the management of SCCHN, our failure to achieve substantial improvements in prognosis for the majority of SCCHN patients underscores the need to investigate effective strategies for cancer prevention.The presentation of potentially malignant disorders of the oral cavity is highly variable
Aminolevulinic acid (ALA) Photodynamic therapy (PDT) could be safely administered with a light dose up to 4 J/cm[2] and demonstrated activity
In the present trial we examined ALA PDT in oral leukoplakia to determine the optimal light intensity when given with a fixed dose of orally administered ALA, as well as toxicity and tolerability and association with mucosal risk markers
Summary
Each year in the United States over 40,000 new cases of head and neck squamous cell cancer (HNSCC) are diagnosed, with approximately 27,000 of these cases occurring in the oral cavity or pharynx. 1 Oral cavity cancer is associated with a poor prognosis with 5 year survival rates of less than 50%. 1 While incremental advances have been achieved in the management of SCCHN, our failure to achieve substantial improvements in prognosis for the majority of SCCHN patients underscores the need to investigate effective strategies for cancer prevention.The presentation of potentially malignant disorders of the oral cavity is highly variable. Each year in the United States over 40,000 new cases of head and neck squamous cell cancer (HNSCC) are diagnosed, with approximately 27,000 of these cases occurring in the oral cavity or pharynx. 1 Oral cavity cancer is associated with a poor prognosis with 5 year survival rates of less than 50%. 1 While incremental advances have been achieved in the management of SCCHN, our failure to achieve substantial improvements in prognosis for the majority of SCCHN patients underscores the need to investigate effective strategies for cancer prevention. The presentation of potentially malignant disorders of the oral cavity is highly variable. 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
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