Randomized Trial of Four Treatment Approaches for Actinic Keratosis

Jansen, Maud H.E.; Kessels, Janneke P H M; Nelemans, Patty J.; Kouloubis, Nina; Arits, A.H.M.M.; Pelt, Han P. A. van; Quaedvlieg, Patricia J F; Essers, Brigitte; Steijlen, P.M.; Kelleners‐Smeets, Nicole W.J.; Mosterd, Klara

doi:10.1056/nejmoa1811850

Cited by 188 publications

(199 citation statements)

References 21 publications

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“…PDT for AKs has excellent if not superior outcomes when compared to other treatments, and recent studies suggest that PDT with 5‐FU pretreatment produces synergistic effects . Most recently, a randomized trial comparing 5‐FU, 5% imiquimod, MAL‐PDT, and ingenol mebutate found the cumulative probability of remaining disease free at 12 months in the group treated with 5‐FU (74.7%; 95% CI 66.8‐81.0), with 5% imiquimod (53.9%; 95% CI 45.4‐61.6), MAL‐PDT (37.7%; 95% CI 30.0‐45.3), and ingenol mebutate (28.9%; 95% CI 21.8‐36.3)), and the hazard ratio of treatment failure with MAL‐PDT compared to 5‐FU was 2.73 (95% CI 1.87‐3.99) …”

Section: Efficacy For Solid Tumorsmentioning

confidence: 99%

Photodynamic therapy for solid tumors: A review of the literature

Yanovsky

Bartenstein

Rogers

et al. 2019

Photoderm Photoimm Photomed

170

102

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Photodynamic therapy (PDT) utilizes a sensitizer agent and light to produce selective cell death. Dermatologists are familiar with PDT for the treatment of actinic keratoses and early nonmelanoma skin cancers, and recent studies have elucidated that PDT has resulted in improved morbidity and secondary outcomes for the treatment of various cancerous and precancerous solid tumors. Light source and dosimetry may be modified to selectively target tissue, and novel techniques such as fractionation, metronomic pulsation, continuous light delivery, and chemophototherapy are under investigation for further optimization of therapy. This article aims to review the expanding indications for PDT and demonstrate the potential of this modality to decrease morbidity and increase quality of life for patients. To illustrate these new indications, we provide a focused review of the latest literature on PDT for dermatologic and other solid tumors including gastrointestinal, peritoneal, lung, genitourinary, brain, breast, and head and neck. Data on efficacy, survival, and side effects vary across tumor types but support PDT for the treatment of numerous solid tumors. With new advances in PDT, indications for this therapeutic modality may expand.

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Section: Efficacy For Solid Tumorsmentioning

confidence: 99%

Photodynamic therapy for solid tumors: A review of the literature

Yanovsky

Bartenstein

Rogers

et al. 2019

Photoderm Photoimm Photomed

170

102

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“…A recently published clinical trial showed that topical 5% fluorouracil (5-FU) was significantly more effective than imiquimod, methyl aminolevulinate-PDT (MAL-PDT) or ingenol mebutate at 12 months after the end of treatment for multiple AK lesions [16]. Similar findings were shown in a network meta-analysis [17].…”

Section: -Fluorouracilmentioning

confidence: 63%

Management Pearls on the Treatment of Actinic Keratoses and Field Cancerization

Piquero-Casals¹,

Morgado‐Carrasco

Gilaberte

et al. 2020

Dermatol Ther (Heidelb)

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Field cancerization (FC) is a chronic disease involving multiple clinical and subclinical actinic keratoses (AK) on large photo-exposed surfaces with multifocal areas of dysplasia and precancerous changes. Patients and treatment must be properly monitored and managed to avoid aggravation and progression of the disease. Management of actinic keratoses includes lesion-directed treatments, such as cryotherapy and field-directed therapies. Field-directed therapies may have the potential to address subclinical damage, reduce AK recurrence rates and potentially reduce the risk of squamous cell carcinoma development. Multiple studies have demonstrated the efficacy of field-directed treatments, including 5-fluorouracil, photodynamic therapy, imiquimod, chemical exfoliation with trichloroacetic acid and diclofenac gel, for multiple AK and FC. The choice of therapy should be based on multiple factors, such as efficacy, tolerability, patient risk profile, costs and cosmetic results. Management of AK includes not only treatment but also prevention. Medical devices, such as sunscreens containing liposome-encapsulated DNA repair enzymes, can repair DNA damage associated with chronic UV radiation and reduce the number of new AK lesions. Here we provide therapeutic pearls and expert opinions on the treatment of AK and FC (as monotherapy or in combination) with the overall aim to achieve better, faster, and well-tolerated clinical responses.

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“…This is a head‐to‐head evaluation of four common AK field treatments . Rather than an outcome immediately post‐treatment, this trial's primary outcome was longer term: AK reduction at 12 months.…”

Section: Commentmentioning

confidence: 99%

Comparing the efficacy of field treatments for actinic keratosis: a critical appraisal of a randomized trial in the New England Journal of Medicine

Wehner

2020

Br J Dermatol

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Aim Jansen et al. conducted a randomized trial to compare the efficacy of four field treatments for actinic keratosis (AK). Setting and design This was a multicentre, single-blind, randomized trial conducted in the dermatology departments of four Netherlands hospitals. Patients were not blinded. The investigator who evaluated the trial outcome was blinded. Study exposure This study included adult patients with at least five AKs on the face or vertex scalp. Patients were randomized to treatment with fluorouracil 5% cream, imiquimod 5% cream, methyl aminolaevulinate photodynamic therapy (MAL-PDT) or ingenol mebutate 0Á015% gel. Outcomes The primary outcome was whether patients had ≥ 75% reduction in AK count 12 months after treatment. Results In total 624 patients participated. The likelihood of having ≥ 75% reduction in AK count 12 months after treatment was significantly higher (twice as high or greater) for fluorouracil than for any other therapy. Approximately 75% of patients treated with fluorouracil experienced ≥ 75% reduction in AK count at 12 months. Conclusions Jansen et al. conclude that 1 year after treatment, fluorouracil was significantly more effective at AK reduction than imiquimod, MAL-PDT or ingenol mebutate. CommentWhat is already known?When patients have multiple actinic keratoses (AKs) in one area, a variety of field treatments can be employed to treat the entire area. There is evidence that field treatments may decrease future AK and squamous cell carcinoma development. 1,2 However, there are very few randomized trials that directly compare different field treatments to help providers and patients choose the most efficacious option. StrengthsThis is a head-to-head evaluation of four common AK field treatments. 3 Rather than an outcome immediately post-treatment, this trial's primary outcome was longer term: AK reduction at 12 months. All severities of AKs were eligible, which was not always the case in prior studies. 4 Additionally, this trial is methodologically sound and appropriately powered. Assessment of validity Internal validity Enrolment, dropout and crossoversThe enrolment rate was 53%, which, while low for a trial, is not unreasonable for a study of nonfatal skin lesions in older patients. The ages of those who did and did not participate were similar, although relatively more eligible men than women participated. Dropout and crossovers were low: approximately 6% dropped out prior to the 12-month followup, and 1% crossed over to a different therapy. RandomizationPatients were randomized 1 : 1 : 1 : 1 to the four treatment arms: fluorouracil 5% cream, imiquimod 5% cream, methyl aminolaevulinate photodynamic therapy (MAL-PDT) or ingenol mebutate 0Á015% gel. Randomization was stratified by ©

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Randomized Trial of Four Treatment Approaches for Actinic Keratosis

Cited by 188 publications

References 21 publications

Photodynamic therapy for solid tumors: A review of the literature

Photodynamic therapy for solid tumors: A review of the literature

Management Pearls on the Treatment of Actinic Keratoses and Field Cancerization

Comparing the efficacy of field treatments for actinic keratosis: a critical appraisal of a randomized trial in the New England Journal of Medicine

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