Photodynamic therapy vs. imiquimod 5% cream as skin cancer preventive strategies in patients with field changes: a randomized intraindividual comparison study.

BACKGROUND: Actinic damage is responsible for the development of multiple, recurrent non-melanoma skin cancers (NMSCs), including actinic keratoses (AKs). Photodynamic therapy (PDT) and imiquimod cream (IMIQ) 5% are recommended as field-directed treatment options. OBJECTIVES: To compare efficacy and safety of methyl aminolevulinate (MAL)-PDT vs. IMIQ 5% in the prevention of new NMSCs development patients with field changes. METHODS: Patients with field cancerization of the face or scalp were randomized to receive MAL-PDT on one side, and IMIQ 5% on the mirror field. The primary endpoint was the number of new lesions on the treated fields during a 12-month follow-up period. Secondary assessments included adverse events and patient preference. RESULTS: Forty-four patients completed the study. MAL-PDT and IMIQ did not differ concerning the primary endpoint, as there was no statistically significant difference in terms of development of new NMSCs at any point of follow-up. Both treatment regimens were safe and well tolerated. Patients' preference based on the procedure, response rates and future choice favoured MAL-PDT. CONCLUSIONS: MAL-PDT and IMIQ 5% are safe and well-tolerated treatments that equally prevent development of new AKs in patients suffering from field changes. MAL-PDT treatment appears to be superior in terms of patients' preference.

Single vs. fractionated photodynamic therapy for face and scalp actinic keratoses: a randomized, intraindividual comparison trial with 12-month follow-up.

OBJECTIVE: To compare the efficacy and tolerability of a single ALA-PDT illumination scheme with that of a fractionated ALA-PDT illumination scheme in face and scalp actinic keratoses (AKs). METHODS: Eligible patients received either a single ALA-PDT illumination or a fractionated illumination scheme randomly allocated to alternate sides of face/scalp. The side allocated to a single illumination received 75 J/cm(2). This side received 2 sessions performed 7 days apart. Lesions on the fractionated illumination scheme side received 20 and 80 J/cm(2), 4 and 6 hours after a single ALA application. Patients were evaluated at baseline, at 3 and 12 months after treatment. Efficacy end point included the individual AK lesion clearance rate. RESULTS: Thirty three patients with 266 lesions were enrolled in the study. Three months after treatment the overall lesion complete response rate was 89.05% for the single scheme and 96.12% for the fractionation scheme while at the 12-months follow-up response rate decreased to 85.4% for the single illumination and to 93.79% for the fractionated illumination group. Looking at lesion response based on lesion grade fractionated photodynamic therapy (PDT) resulted in larger rates of cured grade I as well as grade II lesions. Recorded adverse events were transient and did not demand additional therapy. CONCLUSIONS: Our results demonstrate that higher responses are achieved with fractionated PDT compared with single illumination PDT. The study data indicate that fewer treatment sessions may be needed with fractionated PDT increasing that way the comfort of the patient regarding number of visits, treatment cost and treatment-related downtime.

Sequential use of photodynamic therapy and imiquimod 5% cream for the treatment of actinic cheilitis: a 12-month follow-up study.

BACKGROUND: Actinic cheilitis (AC) may progress into fully developed squamous cell carcinoma with a relatively high risk of metastasizing and therefore requires early identification and treatment. OBJECTIVES: To assess the clinical and histological long-term outcome as well as the safety and tolerability of sequential use of photodynamic therapy (PDT) and imiquimod in AC. METHODS: Patients with histologically confirmed grade 1 and 2 AC received two methyl aminolaevulinate-PDT sessions 2weeks apart. After a 2-week rest period the patients started applying imiquimod 5% cream 3days per week for 4weeks. At the first follow-up visits at 3 and 6months, noncomplete clinical responders were biopsied and excluded from the study if histological alterations were indicative for AC. At the last 12-month follow-up all remaining patients were biopsied. Adverse events were noted at weeks 2, 4, 6 and 8 of the treatment phase and at every visit of the follow-up period. RESULTS: Of the 34 enrolled patients, 30 completed the study. Complete clinical response was achieved by 27 patients in 3months. At 6months, clinical and histological recurrence occurred in two patients, while at 12months the complete clinical cure rate obtained was 80% and the histological complete cure rate was 73%. Treatment was well tolerated and adverse events were as expected and transient. CONCLUSION: Sequential use of PDT and imiquimod cream is of significant benefit for the treatment of AC. Further studies are needed in order to confirm the improved outcome using the combination treatment, to clarify the involved mechanisms and to optimize the therapeutic protocol.

Photodynamic therapy with 5-aminolevulinic acid in actinic cheilitis: an 18-month clinical and histological follow-up.

BACKGROUND: Actinic cheilitis (AC) may bear the initial and superficial changes of actinically induced squamous cell carcinoma (SCC) and may progress into fully developed SCCs. Early and effective treatment is important. OBJECTIVE: To assess the clinical and histological long-term outcome in AC after two ALA-PDT sessions. METHODS: Patients with histologically proven grade 1 and 2 AC received two ALA-PDT sessions at 2 weeks interval. Subjects with complete clinical response at 3 months were evaluated further clinically and histologically at months 6, 12 and 18. Long-term study outcome was defined as clinical and histological AC recurrence among patients with complete clinical response 3 months after treatment. Cosmetic outcome was assessed by the investigators at the final follow-up visit at 18 months. RESULTS: Of the 40 patients enrolled, 38 completed the study. Complete clinical response at 3 months was achieved in 26 patients. At 6 months, clinical and histological recurrence occurred in three patients and at 12 months, one more patient showed clinical and histological recurrence. At 18 months, overall clinical recurrence rate was 15.38% (4/26), while overall histological recurrence rate was 34.61% (9/26). Cosmetic outcome was rated as excellent in more than 80% of evaluated cases. CONCLUSION: PDT represents a moderately effective treatment modality in AC. Optimization of treatment procedure and protocols is still needed for higher response rates to be achieved. Moreover, the high treatment cost should be given consideration. Further long-term follow-up studies are needed for assessment of clinical and histological very late recurrences that could be expected after PDT.

Skin cancer: preventive photodynamic therapy in patients with face and scalp cancerization. A randomized placebo-controlled study.

Background Patients with a previous medical history of nonmelanoma skin cancers (NMSCs) often develop multiple or recurrent malignant lesions around the site of the primary tumour. This finding led to the field cancerization theory, which suggests that the entire epithelial surface of the regional skin has an increased risk for the development of malignant lesions. Management of field change is challenging, taking into account the high impact of NMSCs on public health and healthcare costs. Objectives We sought to investigate whether field-photodynamic therapy (PDT) of extreme photodamaged skin would prevent new NMSCs, in comparison with a control area receiving placebo-PDT, in patients with clinical and histological signs of field cancerization. Methods Forty-five patients, previously diagnosed as having NMSCs of the face or scalp, with actinic keratoses symmetrically distributed over the same regions, were randomized for field treatment with 20% aminolaevulinic acid (ALA)-PDT on one side and placebo-PDT on the other. During the next 12-month period of follow up, patients were clinically evaluated for new NMSCs. Results A significant delay in the mean time of appearance and a reduction in the total number of new lesions were observed in the field-PDT protocol, when compared with the control. Conclusions The results obtained showed that field therapy with ALA-PDT confers a significant preventive potential against the formation of new NMSCs in patients with field changes.