Five-Year Follow-up of a Randomized, Prospective Trial of Topical Methyl Aminolevulinate Photodynamic Therapy vs Surgery for Nodular Basal Cell Carcinoma | Dermatology | JAMA Dermatology | JAMA Network
[Skip to Navigation]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
Horn  MWolf  PWulf  HC  et al.  Topical methyl aminolaevulinate photodynamic therapy in patients with basal cell carcinoma prone to complications and poor cosmetic outcome with conventional treatment.  Br J Dermatol 2003;149 (6) 1242- 1249PubMedGoogle ScholarCrossref
Vinciullo  CElliott  TFrancis  D  et al.  Photodynamic therapy with topical methyl aminolaevulinate for “difficult-to-treat” basal cell carcinoma.  Br J Dermatol 2005;152 (4) 765- 772PubMedGoogle ScholarCrossref
Szeimies  RMMorton  CASidoroff  ABraathen  LR Photodynamic therapy for non-melanoma skin cancer.  Acta Derm Venereol 2005;85 (6) 483- 490PubMedGoogle Scholar
Thissen  MRTMNeumann  MHASchouten  LJ A systematic review of treatment modalities for primary basal cell carcinomas.  Arch Dermatol 1999;135 (10) 1177- 1183PubMedGoogle Scholar
Telfer  NRColver  GBBowers  PW Guidelines for the management of basal cell carcinoma.  Br J Dermatol 1999;141 (3) 415- 423PubMedGoogle ScholarCrossref
Angell-Petersen  ESørensen  RWarloe  T  et al.  Porphyrin formation in actinic keratosis and basal cell carcinoma after topical application of methyl 5-aminolevulinate.  J Invest Dermatol 2006;126 (2) 265- 271PubMedGoogle ScholarCrossref
Rhodes  LEde Rie  MEnström  Y  et al.  Photodynamic therapy using topical methyl aminolevulinate vs surgery for nodular basal cell carcinoma: results of multicenter randomized prospective trial.  Arch Dermatol 2004;140 (1) 17- 23PubMedGoogle Scholar
Rowe  DECarroll  RJDay  CL Long-term recurrence rates in previously untreated (primary) basal cell carcinoma: implications for patient follow-up.  J Dermatol Surg Oncol 1989;15 (3) 315- 328PubMedGoogle ScholarCrossref
Guo  SWLin  DY Regression analysis of multivariate grouped survival data.  Biometrics 1994;50 (3) 632- 639PubMedGoogle ScholarCrossref
Silverman  MKKopf  AWBart  RSGrin  CMLevenstein  MS Recurrence rates of treated basal cell carcinomas, part 3: surgical excision.  J Dermatol Surg Oncol 1992;18 (6) 471- 476PubMedGoogle ScholarCrossref
Bath-Hextall  FBong  JPerkins  WWilliams  H Interventions for basal cell carcinoma of the skin: systematic review.  BMJ 2004;329 (7468) 705- 709PubMedGoogle ScholarCrossref
Morton  CABrown  SBCollins  S  et al.  Guidelines for topical photodynamic therapy: report of a workshop of the British Photodermatology Group.  Br J Dermatol 2002;146 (4) 552- 567PubMedGoogle ScholarCrossref
September 2007

Five-Year Follow-up of a Randomized, Prospective Trial of Topical Methyl Aminolevulinate Photodynamic Therapy vs Surgery for Nodular Basal Cell Carcinoma

Author Affiliations

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).

Arch Dermatol. 2007;143(9):1131-1136. doi:10.1001/archderm.143.9.1131

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.