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Background: Basal cell carcinoma (BCC) represents the most common non-melanoma skin cancer worldwide affecting mainly adult, fair-skinned individuals. The WHO distinguishes aggressive and non-aggressive forms of which prototypical variants of the latter are primary nodular and superficial BCC. Objectives: To demonstrate non-inferiority of BF-200 ALA (a nanoemulsion gel containing 5-aminolaevulinic acid) compared to MAL (a cream containing methyl-aminolevulinate) in the treatment of non-aggressive BCC with photodynamic therapy (PDT). Non-inferiority of the primary efficacy variable (overall patient complete response 12 weeks after last PDT) would be declared if the mean response for BF-200 ALA was no worse than that for MAL, within a statistical margin of Δ = -15%. Patients/Methods: The study was a randomized, phase III trial performed in Germany and the UK with ongoing 5-year follow-up. Of 281 randomized patients, 138 were treated with BF-200 ALA, 143 with MAL. Patients received two PDT sessions one week apart. Remaining lesions 12 weeks after the second PDT were retreated. Illumination was performed with a red light source (635 nm, 37 J/cm2). Results shown include clinical endpoints as well as patients’ reassessment 12 months after the last PDT. Results: Of the BF-200 ALA-treated patients, 93.4% were complete responders compared to 91.8% in the MAL group. The difference of means was 1.6 with a one-sided 97.5% CI of -6.5, establishing non-inferiority (p<0.0001). Results for secondary efficacy parameters were in line with the primary outcome. Recurrence rates 12 months after the last treatment were ≤ 10%. Conclusions: Treatment of non-aggressive BCC with BF-200 ALA-PDT is highly effective and well tolerated with proven non-inferiority to MAL-PDT and demonstrates low recurrence rates after 1-year follow-up.

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Autor(es)

Morton, C.A. -  Dominicus, R. -  Radny, P. -  Dirschka, T. -  Hauschild, A. -  Reinhold, U. -  Aschoff, R. -  Ulrich, M. -  Keohane, S. -  Ekanayake -  Bohlig, S. -  Ibbotson, S. -  Ostendorf, R. -  Berking, C. -  Gröne, D. -  Schulze, H.J. -  Ockenfels, H.M. -  Jasnoch, V. -  Kurzen, H. -  Sebastian, M. -  Stege, H. -  Staubach -  Renz, P. -  Gupta, G. -  Hübinger, F. -  Ziabreva, I. -  Schmitz, B. -  Gertzmann, A. -  Lübbert, H. -  Szeimies, R. -  M. - 

Id.: 71026986

Idioma: inglés  - 

Versión: 1.0

Estado: Final

Tipo:  text - 

Tipo de recurso: Articles  -  PeerReviewed  - 

Tipo de Interactividad: Expositivo

Nivel de Interactividad: muy bajo

Audiencia: Estudiante  -  Profesor  -  Autor  - 

Estructura: Atomic

Coste: no

Copyright: sí

Formatos:  text - 

Requerimientos técnicos:  Browser: Any - 

Relación: [References] http://eprints.gla.ac.uk/157407/
[References] 10.1111/bjd.16441

Fecha de contribución: 10-mar-2018

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* Morton, C.A. et al. (2018) A randomized, multi-national, non-inferiority, phase III trial to evaluate the safety and efficacy of BF-200 ALA gel versus MAL cream in the treatment of non-aggressive basal cell carcinoma with photodynamic therapy (PDT). British Journal of Dermatology , (doi:10.1111/bjd.16441 ) (PMID:29432644) (Early Online Publication)

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