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Results of a Multicenter Randomized Prospective Trial

Lesley E. Rhodes, MD, FRCP; Menno de Rie, MD; Ylva Enström, MD; Richard Groves, FRCP; Tore Morken, MD; Victoria Goulden, MRCP; Gavin A. E. Wong, MRCP; Jean-Jacques Grob, MD; Sandeep Varma, MRCP; Peter Wolf, MD

Arch Dermatol. 2004;140:17-23.

Background  Photodynamic therapy (PDT) is increasingly used as a noninvasive treatment for nodular basal cell carcinoma (BCC), without a sound evidence base.

Objective  To compare topical PDT, with the use of the sensitizer methyl aminolevulinate, and standard excision surgery in nodular BCC.

Design  Prospective, randomized study.

Setting  University dermatology departments.

Patients  A total of 101 adults with previously untreated nodular BCC.

Interventions  Patients received methyl aminolevulinate PDT (n = 52) or surgery (n = 49). The PDT was given twice, 7 days apart, with methyl aminolevulinate cream (160 mg/g) and 75 J/cm² red light (570-670 nm). Thirteen patients with a noncomplete response to PDT at 3 months (24% lesions) were retreated.

Outcome Measures  Primary end point was clinically assessed lesion clearance at 3 months after treatment. Secondary end points were sustained response rate at 12 months and cosmetic outcome at 3 and 12 months. Cosmesis and lesion recurrence were further assessed at 24 months.

Results  Data from 97 patients (105 lesions) were included in the 3-month per-protocol analysis. Complete response rates did not differ significantly between groups (51/52 [98%] lesions with surgery vs 48/53 [91%] lesions with methyl aminolevulinate PDT; difference [95% confidence interval], 4.8% (-3.4% to 13.0%]; P = .25). At 12 months, tumor-free rates were 50 (96%) of 52 lesions with surgery vs 44 (83%) of 53 with methyl aminolevulinate PDT (P = .15). More patients treated with methyl aminolevulinate PDT than surgery had an excellent or good cosmetic outcome at all time points (significant at 12 and 24 months on patient assessment, P<.05, and at 3, 12, and 24 months on investigator evaluation, P<.001). At 24 months, 5 lesions that had initially cleared with methyl aminolevulinate PDT had recurred, compared with 1 after surgery.

Conclusions  Methyl aminolevulinate PDT is an effective treatment for nodular BCC, and while there is a trend for higher recurrence with this modality, it conveys the advantage over surgery of better cosmesis.

From the Departments of Dermatology, Royal Liverpool University Hospital, Liverpool, England (Drs Rhodes and Wong), Academic Medical Centre, Amsterdam, the Netherlands (Dr de Rie), and Norra Älvsborgs Länssjukhus, Trollhättan, Sweden (Dr Enström); Centre of Dermatology, University College London, London, England (Dr Groves); Departments of Dermatology, Haukeland Hospital, Bergen, Norway (Dr Morken), Leeds General Infirmary, Leeds, England (Dr Goulden), Hôpital Sainte-Marguerite, Marseille, France (Dr Grob), University Hospital of Wales, Cardiff, Wales (Dr Varma), and University of Graz, Graz, Austria (Dr Wolf); and Photobiology Unit, Dermatology Centre, University of Manchester, Hope Hospital, Salford, England (Dr Rhodes). The authors have no relevant financial interest in this article.

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