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Comparison of Topical Methyl Aminolevulinate Photodynamic Therapy with Cryotherapy Or Fluorouracil for Treatment of Squamous

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Comparison of Topical Methyl Aminolevulinate Photodynamic Therapy with Cryotherapy Or Fluorouracil for Treatment of Squamous STUDY 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 Colin Morton, MD; Michael Horn, MD; Joyce Leman, MD; Brigitte Tack, MD; Christophe Bedane, MD; Milan Tjioe, MD; Sally Ibbotson, MD; Abdallah Khemis, MD; Peter Wolf, MD Objective: To compare the efficacy, tolerability, and cos- weeks. Lesions with a partial response at 3 months were metic outcome of photodynamic therapy (PDT) using topi- re-treated. cal methyl aminolevulinate with cryotherapy or topical fluo- rouracil for treatment of squamous cell carcinoma in situ. Main Outcome Measures: Clinically verified complete response of lesions; blinded and on-site Design: Randomized, placebo-controlled study, with assessment of cosmetic outcome (4-point rating scale). follow-up at 3 and 12 months after last treatment. Results: At 12 months, the estimated sustained lesion Setting: Forty outpatient dermatology centers in 11 complete response rate with methyl aminolevulinate PDT European countries. was superior to that with cryotherapy (80% vs 67%; odds ratio, 1.77; 95% confidence interval, 1.01-3.12; P=.047), Patients: Random sample of 225 patients with histo- and better than that with fluorouracil (80% vs 69%; odds logically confirmed squamous cell carcinoma in situ ratio, 1.64; 95% confidence interval, 0.78-3.45; P=.19). (lesion size, 6-40 mm) and no evidence of progression. Cosmetic outcome at 3 months was good or excellent in 94% of patients treated with methyl aminolevulinate PDT Interventions: Treatment with PDT with methyl ami- vs 66% with cryotherapy and 76% with fluorouracil, and nolevulinate (160 mg/g; n=96) or matching placebo cream was maintained at 12 months. (n=17), cryotherapy (n=82), or topical fluorouracil (5% cream; n=30). Methyl aminolevulinate or placebo cream Conclusion: Methyl aminolevulinate PDT is an effec- was applied for 3 hours before illumination with broad- tive treatment option for squamous cell carcinoma in situ, band red light (75 J/cm2, 570-670 nm). Treatment was with excellent cosmesis. repeated 1 week later. Cryotherapy was performed with liquid nitrogen spray. Fluorouracil was applied for 4 Arch Dermatol. 2006;142:729-735 ONMELANOMA SKIN CAN- Current treatment guidelines7 suggest cer, including intraepi- that the available treatment options thelial squamous cell car- (including cryotherapy, curettage, exci- Author Affiliations: Forth cinoma (SCC in situ), is sion, and topical fluorouracil) are broadly Valley Dermatology Centre, the most common can- similar in efficacy, with recurrence rates of Stirling Royal Infirmary, Stirling, Scotland (Drs Morton cer in white persons, particularly in north- about 5% to 10% at 12 months. However, N 1 2 and Leman); Medical University western Europe, the United States, and cryotherapy can be painful (up to 10-fold Graz, Graz, Austria (Drs Horn and Wolf); Center Hospitalier See also page 755 Universitaire, Caen, France CME course available at (Dr Tack); Hoˆpital Dupuytren, www.archdermatol.com higher risk of pain than with curettage8), Limoges, France (Dr Bedane); which may limit treatment of multiple St Radboud University Hospital, Australia,3 and the incidence continues to lesions, and healing, particularly of large le- Nijmegen, the Netherlands 4 sions, can be slow (up to 3 months8). Topi- (Dr Tjioe); Ninewells Hospital, rise. Squamous cell carcinoma in situ is especially common in elderly patients, cal fluorouracil can require prolonged treat- Dundee, Scotland 7 (Dr Ibbotson); and Hoˆpital typically occurring on the lower part of the ment and typically causes local irritation. de l’Archet, Nice, France legs.5 The condition is associated with a Photodynamic therapy (PDT) is a non- (Dr Khemis). small risk of progression (about 3%).6 invasiveandpreciselydirectedtreatmentthat (REPRINTED) ARCH DERMATOL/ VOL 142, JUNE 2006 WWW.ARCHDERMATOL.COM 729 ©2006 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 229 Randomized MAL PDT Placebo PDT Cryotherapy Fluorouracil 96 Treated 17 Treated 82 Treated 30 Treated 3 Not Treated 0 Not Treated 0 Not Treated 1 Not Treated 2 Consent Withdrawn 1 Lost to Follow-up 1 Spontaneous Remission MAL PDT Placebo PDT Cryotherapy Fluorouracil 4 Discontinued 2 Discontinued 4 Discontinued 1 Discontinued 1 Consent Withdrawn 1 Lost to Follow-up 2 Lost to Follow-up 1 Adverse Event 3 Adverse Events 1 Adverse Event 1 Adverse Event 1 Other Reason MAL PDT Placebo PDT Cryotherapy Fluorouracil 91 PP Analysis 15 PP Analysis 77 PP Analysis 26 PP Analysis 1 Missing 3-mo Assessment 1 Diagnosis Not Confirmed 3 With Fluorouracil Applied for <50% Planned Figure 1. Disposition of patients in the study. MAL indicates methyl aminolevulinate; PDT, photodynamic therapy; and PP, per protocol. offers promise in this indication. The procedure involves ac- Cryotherapy was performed with a handheld liquid nitro- tivation of a photosensitizing agent by visible light, with sub- gen spray, using a single freeze/thaw cycle. After an initial ice sequent release of reactive oxygen species, especially singlet field formation with a 2-mm rim of clinically healthy tissue, oxygen, which in turn produces local tissue destruction.9 the ice field was maintained for a minimum of 20 seconds. Topi- The aim of this study was to investigate PDT using topical cal 5% fluorouracil cream (Efudix; Valeant Pharmaceuticals In- ternational, Basingstoke, England;) was applied for 4 weeks, methyl aminolevulinate, already shown to be effective in the 10-13 14,15 once daily during the first week and twice daily thereafter. Pa- treatmentofbasalcellcarcinoma andactinickeratoses, tients attended the clinic at weeks 0, 1, and 4, and completed as a treatment for SCC in situ. a diary noting the date and time of each application of cream. In each group, lesions with a partial response (described in the METHODS next section) at 12 weeks were retreated. PATIENTS RESPONSE EVALUATION Patients 18 years or older with histologically confirmed diag- Clinical lesion response was assessed as complete (complete nosis of SCC in situ from a biopsy specimen taken within 5 disappearance of a lesion), partial (reduction in lesion size Ն25% months, and with no evidence of any change in appearance sug- and Ͻ100%), or none (Ͻ25% reduction or an increase in size). gestive of lesion progression, were enrolled in 40 hospital out- Response was followed up at 3 and 12 months after the last treat- patient dermatology clinics in 11 European countries. Lesions ment. Cosmetic outcome was assessed by the treating investi- that had been treated within the previous 3 months or that were gator for all patients in whom all lesions had responded com- strongly pigmented, less than 6 mm or more than 40 mm in pletely by means of a 4-point scale (excellent, good, fair, or poor) diameter, or located on the genitalia were excluded. The study based on the presence of signs and symptoms including scar- was approved by the ethics committee responsible for each cen- ring, atrophy, change in pigmentation, redness, and fibrosis. ter, and all patients gave written informed consent. In addition, cosmetic outcome was assessed from photo- graphs taken before and after treatment by an independent ob- PROCEDURES server who was blinded to the nature of the study treatment. Adverse events were noted at each visit, together with their se- Eligible patients were randomized to PDT with topical methyl verity, duration, and need for additional therapy. aminolevulinate cream, 160 mg/g (Metvix; PhotoCure ASA, Oslo, Norway/Galderma SA, Paris, France), or matching placebo cream STATISTICAL ANALYSIS in a double-blinded fashion, or standard therapy chosen by the treating investigator (cryotherapy or fluorouracil). Assuming that the patient complete response rate with methyl aminolevulinate PDT and standard therapy (cryotherapy or fluo- TREATMENTS rouracil) was 85%, at least 90 patients were required in each active treatment group (methyl aminolevulinate PDT and stan- Before application of methyl aminolevulinate or placebo cream, dard therapy) to be able to show with an ␣ of 5% and a power the lesions were prepared by gentle surface debridement with a cu- of 90% that methyl aminolevulinate PDT was no more than 15% rette. Methyl aminolevulinate PDT was performed as previously inferior to standard therapy. In addition, assuming that the pa- described.10,11,13-15 Briefly, the cream was applied to the lesions for tient complete response rate with placebo PDT was 35%, at least 3 hours, then washed off with 0.9% saline solution before illumi- 15 patients were required in this group (␣, 5%; power, 90%). nation with noncoherent red light (CureLight lamp, PhotoCure Efficacy analyses were based on the per-protocol popula- ASA; wavelength, 570-670 nm; light dose, 75 J/cm2). Patients wore tion, excluding patients in whom the diagnosis of SCC in situ protectiveeyewearwhenlesionsclosetotheeyesweretreated.Treat- was not confirmed or who received less than 50% of fluoro- ment was repeated once after 1 week for a complete treatment cycle. uracil medication and only 1 treatment in the first PDT cycle, (REPRINTED) ARCH DERMATOL/ VOL 142, JUNE 2006 WWW.ARCHDERMATOL.COM 730 ©2006 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/26/2021 Table 1. Patient and Lesion Characteristics at Baseline, All Patients Treated MAL PDT Placebo PDT Cryotherapy Topical Fluorouracil (n = 96) (n = 17) (n = 82) (n = 30) Sex, M:F, No. (%) 36:60 (38:62) 6:11 (35:65) 34:48 (41:59) 11:19 (37:63) Age, mean (range), y 71.9 (43-89) 73.4 (53-88) 74.0 (45-99) 72.5 (39-86) Race, No. (%) white 68 (71) 14 (82) 56 (68) 20 (67) Skin type (Fitzpatrick score), No. (%)* I 10 (10) 4 (24) 3 (4) 6 (20) II 45 (47) 9 (53) 40 (49) 11 (37) III 36 (38) 3 (18) 32 (39) 12 (40) IV/V 5 (5) 1 (6) 7 (9) 1 (3) Total No.
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