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Original Investigation
March 2017

Effect of Methyl Aminolevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell CarcinomaA Randomized Clinical Trial

Author Affiliations
  • 1Department of Dermatology, College of Medicine, Dong-A University, Busan, Republic of Korea
JAMA Dermatol. 2017;153(3):289-295. doi:10.1001/jamadermatol.2016.4463
Key Points

Question  Is photodynamic therapy with and without ablative fractional laser effective in the treatment of microinvasive squamous cell carcinoma?

Findings  In this randomized clinical trial that included 45 patients randomized to treatment with a single ablative fractional laser-primed photodynamic therapy session vs 2 conventional sessions without ablative fractional laser. The proportion achieving long-term complete response of photodynamic therapy was 68.4% with ablative fractional laser vs 14.3% without ablative fractional laser.

Meaning  Photodynamic therapy with ablative fractional laser could be a good alternative treatment option for microinvasive squamous cell carcinoma.

Abstract

Importance  Surgical excision is the standard treatment for cutaneous squamous cell carcinoma (SCC). However, microinvasive SCC (Clark level II) is limited to the papillary dermis, and it should be differentiated from invasive SCC. Ablative fractional laser-primed photodynamic therapy (AFL-PDT) may have enhanced efficacy.

Objective  To compare 1 session of AFL-PDT with 2 sessions of conventional methyl aminolevulinate-PDT (MAL-PDT) for the treatment of microinvasive SCC.

Design, Setting, and Participants  A 2-armed, randomized, single-blind, comparative trial of 45 patients with histologically proven microinvasive SCC. Twenty-one patients were randomized to treatment with a single AFL-PDT session, and 24 patients were randomized to 2 MAL-PDT sessions with a 1-week interval between sessions using a computer-generated program. Standard pretreatment such as curettage was not performed prior to PDT owing to a tendency to bleed. The efficacy, recurrence rate, cosmetic outcomes, and safety were assessed 1 week, 3, 12, and 24 months after the last treatment.

Interventions  AFL was performed with an ablation depth of 550 µm to 600 µm, coagulation level of 1, treatment density of 22%, and a single pulse. Then, MAL cream was applied under occlusion for 3 hours and illuminated by using a red light-emitting diode light at 37 J/cm2. A second session of MAL-PDT was administered after 7 days.

Main Outcomes and Measures  The primary outcome measures were the lesion response at 3 and 12 months, and the recurrence rate 12 months after the last treatment.

Results  Twenty-one patients (6 men, 15 women) with a mean (SD) age of 76 (6) years were randomized to treatment with a single AFL-PDT session, and 24 patients (11 men, 13 women) with a mean (SD) age of 75 (6) years were randomized to 2 MAL-PDT sessions. The overall complete response rates 3 months after treatment were 84.2% with AFL-PDT and 52.4% with MAL-PDT (P = .03). These differences in efficacy remained significant at the 24-month follow-up. The recurrence rate was significantly lower with AFL-PDT (12.5%) than with MAL-PDT (63.6%) at 24 months (P = .006). AFL-PDT and MAL-PDT did not differ significantly with respect to the cosmetic outcomes, adverse events, or pain intensity.

Conclusions and Relevance  AFL-PDT can be used as an alternative treatment option for patients with microinvasive SCC who are not suitable for surgical treatment.

Trial Registration  clinicaltrials.gov Identifier: NCT02666534

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