Comparison of Topical Methyl Aminolevulinate Photodynamic Therapy With Cryotherapy or Fluorouracil for Treatment of Squamous Cell Carcinoma In Situ: Results of a Multicenter Randomized Trial
Abstract
OBJECTIVE: To compare the efficacy, tolerability, and cosmetic outcome of photodynamic therapy (PDT) using topical methyl aminolevulinate with cryotherapy or topical fluorouracil for treatment of squamous cell carcinoma in situ. DESIGN: Randomized, placebo-controlled study, with follow-up at 3 and 12 months after last treatment. SETTING: Forty outpatient dermatology centers in 11 European countries. PATIENTS: Random sample of 225 patients with histologically confirmed squamous cell carcinoma in situ (lesion size, 6-40 mm) and no evidence of progression. INTERVENTIONS: Treatment with PDT with methyl aminolevulinate (160 mg/g; n = 96) or matching placebo cream (n = 17), cryotherapy (n = 82), or topical fluorouracil (5% cream; n = 30). Methyl aminolevulinate or placebo cream was applied for 3 hours before illumination with broadband red light (75 J/cm2, 570-670 nm). Treatment was repeated 1 week later. Cryotherapy was performed with liquid nitrogen spray. Fluorouracil was applied for 4 weeks. Lesions with a partial response at 3 months were re-treated. MAIN OUTCOME MEASURES: Clinically verified complete response of lesions; blinded and on-site assessment of cosmetic outcome (4-point rating scale). RESULTS: At 12 months, the estimated sustained lesion complete response rate with methyl aminolevulinate PDT was superior to that with cryotherapy (80% vs 67%; odds ratio, 1.77; 95% confidence interval, 1.01-3.12; P = .047), and better than that with fluorouracil (80% vs 69%; odds ratio, 1.64; 95% confidence interval, 0.78-3.45; P = .19). Cosmetic outcome at 3 months was good or excellent in 94% of patients treated with methyl aminolevulinate PDT vs 66% with cryotherapy and 76% with fluorouracil, and was maintained at 12 months. CONCLUSION: Methyl aminolevulinate PDT is an effective treatment option for squamous cell carcinoma in situ, with excellent cosmesis.
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Comparing MAL/PDT to cryotherapy and 5-fluorouracil showed similar response rates with all treatments used against SCC in situ at the 12 month follow-up point.
“Comparing MAL/PDT to cryotherapy and 5-fluorouracil showed similar response rates with all treatments used against SCC in situ at the 12 month follow-up point [58].”
From Photodynamic Therapy for Non-Melanoma Skin Cancers (2016) · cites this paper as [58]
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- Authors
- Morton, C., Horn, M., Leman, J., Tack, B., Bedane, C., Tjioe, M., Ibbotson, S., Khemis, A., & Wolf, P.
- Venue
- Archives of Dermatology
- Publisher
- American Medical Association (AMA)
- Published
- 2006-06-01
- Volume
- 142
- Issue
- 6
- Pages
- 729-35
- ISSN
- 0003-987X (ISSN-L)
- OpenAlex
- W2125566133
- Cited by
- 256
- References
- 17
- Citations by year
- 2026: 6 · 2025: 11 · 2024: 15 · 2023: 12 · 2022: 12 · 2021: 12 · 2020: 7 · 2019: 10 · 2018: 16 · 2017: 12 · 2016: 13 · 2015: 15 · 2014: 8 · 2013: 15 · 2012: 12
- FWCI
- 9.27
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Archives of Dermatology (publishedVersion)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (publishedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Nonmelanoma Skin Cancer Studies
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Photodynamic Therapy Research Studies
- Health Sciences › Medicine › Dermatology › Skin Protection and Aging
- Keywords
- methyl aminolevulinate, photodynamic therapy, Bowen's disease, cryotherapy, topical fluorouracil, cosmetic outcome, treatment efficacy, actinic keratosis, tolerability, recurrence prevention, liquid nitrogen cryotherapy, topical chemotherapy
- MeSH terms
- Administration, Cutaneous, Adult, Aged, Aged, 80 and over, Aminolevulinic Acid, Antimetabolites, Antineoplastic, Carcinoma, Squamous Cell, Double-Blind Method, Europe, Female, Fluorouracil, Humans, Male, Middle Aged, Photochemotherapy, Skin Neoplasms, Treatment Outcome, Photosensitizing Agents, Cryotherapy
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