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Lesley E. Rhodes, MD, FRCP; Menno A. de Rie, MD; Ragna Leifsdottir, MD; Raymond C. Yu, MD, FRCP; Ingeborg Bachmann, MD; Victoria Goulden, MD, FRCP; Gavin A. E. Wong, MRCP; Marie-Aleth Richard, MD; Alex Anstey, MD, FRCP; Peter Wolf, MD

Arch Dermatol. 2007;143(9):1131-1136.

Objective  To compare 5-year lesion recurrence rates in primary nodular basal cell carcinoma treated with topical methyl aminolevulinate photodynamic therapy (PDT) or simple excision surgery.

Design  Prospective, randomized, multicenter study.

Setting  University hospital dermatology departments.

Patients  A total of 97 patients, 50 with 53 lesions treated with methyl aminolevulinate PDT and 47 with 52 lesions treated by excision surgery, were included in the per protocol analysis. Of the lesions treated with methyl aminolevulinate PDT and surgery, 49 and 52, respectively, showed complete clinical response at 3 months after treatment and were observed for long-term outcome evaluation.

Interventions  Topical methyl aminolevulinate cream, 160 mg/g, applied for 3 hours before illumination (75 J/cm² of red light at 570 to 670 nm) on 2 or 4 occasions (12 [23%] of 53 lesions); or excision surgery.

Main Outcome Measures  Histologically confirmed lesion recurrence, sustained lesion complete response rate (time-to-event analysis), and investigator assessment of cosmetic outcome, 5 years after the last treatment.

Results  At 5 years, recurrence was documented in 7 (14%) of 49 lesions (95% confidence interval [CI], 6%-27%) treated with methyl aminolevulinate PDT vs 2 (4%) of 52 lesions (95% CI, 1%-13%) treated with excision surgery (P = .09). Estimated sustained lesion complete response rates were 76% (95% CI, 59%-87%) and 96% (95% CI, 84%-99%), respectively (P = .01). More patients treated with methyl aminolevulinate PDT than surgery had an excellent or good cosmetic outcome: 27 (87%) of 31 patients (95% CI, 70%-96%) vs 19 (54%) of 35 patients (95% CI, 37%-71%) (P = .007).

Conclusions  Long-term follow-up indicates superior efficacy of surgery to methyl aminolevulinate PDT in nodular basal cell carcinoma. However, methyl aminolevulinate PDT is also an effective treatment for this indication and exhibits a more favorable cosmetic outcome.

Author Affiliations: Photobiology Unit, Departments of Dermatology, University of Manchester and Salford Royal Foundation Hospital, Manchester (Dr Rhodes), University College Hospital, London (Dr Yu), Leeds General Infirmary, Leeds (Dr Goulden), and Royal Liverpool University Hospital, Liverpool (Dr Wong), England; Academic Medical Centre, Amsterdam, the Netherlands (Dr de Rie); Norra Älvsborgs Länssjukhus, Trollhättan, Sweden (Dr Leifsdottir); Haukeland Hospital, Bergen, Norway (Dr Bachmann); Hôpital Sainte-Marguerite, Marseille, France (Dr Richard); University Hospital of Wales, Cardiff (Dr Anstey); and Medical University Graz, Graz, Austria (Dr Wolf).

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