Efficacy of Photodynamic Therapy vs Other Interventions in Randomized Clinical Trials for the Treatment of Actinic Keratoses

Abstract

IMPORTANCE Photodynamic therapy (PDT) is used extensively to treat actinic keratoses(AKs). An analysis of the effectiveness of PDT compared with other treatments may help physicians decide what role it should play in their own clinical practices.OBJECTIVE To determine the effectiveness of PDT for the treatment of AKs relative to other methods.DATA SOURCES MEDLINE, EMBASE,Web of Knowledge, and Cochrane Central Register. No restrictions on years were placed, and all searches extended to the year of each data base inception. Our search was conducted on March 20, 2013, and included the search terms solar keratosis, actinic keratosis, photodynamic therapy, and photochemotherapy. No restrictions were used for the search string.STUDY SELECTION Only randomized PDT trials that used aminolevulinic acid hydrochloride ormethyl aminolevulinate hydrochloride as stabilizers with 10 or more participants were considered. Two of the authors undertook the search independently.DATA EXTRACTION AND SYNTHESIS Data were extracted independently by the 2 authors.We assessed data quality using the Jadad scoring system and used a random-effects model for pooled data analysis.MAIN OUTCOMES AND MEASURES Primary outcome measures specified a priori were lesion response, cosmetic results, and patient satisfaction after the intervention.RESULTS Our search identified 875 journal articles and meeting abstracts.We excluded 862 owing to lack of adherence to our inclusion criteria or lack of author response to our queries for further information.We assessed 13 studies for inclusion in our final synthesis, of which 4 were eligible for final meta-analysis. The only comparator for which meta-analysis was performed was cryotherapy. The meta-analysis consisted of 641 participants, with a total of 2174 AKs treated with cryotherapy and 2170 AKs treated with PDT. Compared with cryotherapy, the pooled relative risk for the meta-analysis for complete response (lesion clearance) was 1.14 (95%CI, 1.11-1.18) at 3 months after treatment. Visual inspection of a funnel plot revealed no publication bias, which was confirmed by the Begg test (P = .80).CONCLUSIONS AND RELEVANCE Photodynamic therapy has a 14%better chance of complete lesion clearance at 3 months after treatment than cryotherapy for thin AKs on the face and scalp.

European Dermatology Forum guidelines on topical photodynamic therapy 2019 Part 1: treatment delivery and established indications – actinic keratoses, Bowen's disease and basal cell carcinomas

“…Based on investigator and participant evaluation, imiquimod and PDT resulted in better cosmetic outcomes than cryotherapy and 5‐fluorouracil. A further systematic review performed in 2013 undertook to compare the evidence of the effectiveness of PDT compared with other therapies, restricted to RCTs with at least 10 participants . Thirteen studies were included in the final synthesis, of which 4 were eligible for final meta‐analysis.…”

Photodynamic therapy in dermatology beyond non-melanoma cancer: An update

“…AKs respond well to PDT; in a network meta-analysis for 5-ALA PDT, cryotherapy, diclofenac 3% in 2.5% hyaluronic acid (DCF/HA), 5-fluorouracil (5-FU) 0.5% or 5.0%, imiquimod 5%, ingenol mebutate (IMB) 0.015–0.05%, MAL-PDT and placebo, the relative efficacy rankings were as follows: 5-FU > ALA-PDT ≈ IMI ≈ IMB ≈ MAL-PDT > cryotherapy > DCF/HA > placebo [13]. Another meta-analysis including 9 randomized PDT clinical trials compared ALA-PDT or MAL-PDT with cryotherapy, PDT had a 14% better chance of lesion clearance compared with cryosurgery for thin AKs on the face or scalp [14]. Efficacy, cosmetic outcome and patient overall satisfaction with MAL-PDT were reported to be superior in comparison with DCF/HA in a recent randomized clinical trial [15].…”

Daylight photodynamic therapy with methyl aminolevulinate cream is effective and nearly painless in treating actinic keratoses: a randomised, investigator‐blinded, controlled, phase III study throughout Europe

“…A review of six clinical studies of AK treatment with c‐PDT using MAL notes a good efficacy in terms of complete lesion response, from mild to moderate lesions, on the face or scalp, regardless of the number of lesions treated at baseline . C‐PDT is a first‐line treatment option for multiple and/or confluent AKs, as supported by various European and international guidelines and reviews …”