Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma

A Randomised Trial Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: Results From a 24-month Follow-up

Surgical excision is the standard treatment for cutaneous SCC. However, many patients diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser- assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional Methylaminolevulinate (MAL)-PDT.

Squamous cell carcinoma (SCC) lesions are potentially metastatic and can be life threatening. Hence, surgical excision is the standard treatment for cutaneous SCC. However, some patients are ineligible for surgery because of their poor general health, concomitant anticoagulant or immunosuppressive therapies, or allergy to local anesthetics.

Photodynamic therapy (PDT) with methylaminolevulinate (MAL) is an innovative treatment modality that has been approved in Europe for the treatment of actinic keratosis, basal cell carcinoma, and Bowen's disease. However, currently, there is insufficient evidence to support the routine use of topical PDT for SCC.

Ablative fractional laser (AFL) ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones in the portion of the skin that the laser is applied to. Our previous studies showed that AFL-primed MAL-PDT (AFL-PDT) offered a higher efficacy than conventional MAL-PDT in the treatment of many other diseases, such as actinic keratosis, actinic cheilitis, and Bowen's disease.

Investigators recruited Korean patients with microinvasive SCC and compared the efficacy, recurrence rate, and cosmetic outcomes of AFL-PDT with those of standard MAL-PDT.

Inclusion Criteria:

• Patients aged 18 years or more who had previously untreated microinvasive SCC, providing they satisfied both of the following conditions:

  • tumor invasion into the papillary dermis (Clark level II) according to a biopsy specimen and
  • difficulty in surgical excision because of health problems (bleeding tendency or cardiac problems)

Exclusion Criteria:

• pregnancy or lactation
• active systemic infectious disease
• other inflammatory, infectious, or neoplastic skin diseases in the treated area
• allergy to MAL,other topical photosensitizers, or excipients of the cream
• history of photosensitivity
• use of immunosuppressive or photosensitizing drugs
• participation in any other investigational study in the preceding 30 days
• history or indicators of poor compliance
• Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis were the disease-specific exclusion criteria