Conflicts of interest None declared.
Fractionated 5-aminolaevulinic acid–photodynamic therapy vs. surgical excision in the treatment of nodular basal cell carcinoma: results of a randomized controlled trial
Article first published online: 20 AUG 2008
© 2008 The Authors. Journal Compilation © 2008 British Association of Dermatologists
British Journal of Dermatology
Volume 159, Issue 4, pages 864–870, October 2008
How to Cite
Mosterd, K., Thissen, M.R.T.M., Nelemans, P., Kelleners-Smeets, N.W.J., Janssen, R.L.L.T., Broekhof, K.G.M.E., Neumann, H.A.M., Steijlen, P.M. and Kuijpers, D.I.M. (2008), Fractionated 5-aminolaevulinic acid–photodynamic therapy vs. surgical excision in the treatment of nodular basal cell carcinoma: results of a randomized controlled trial. British Journal of Dermatology, 159: 864–870. doi: 10.1111/j.1365-2133.2008.08787.x
- Issue published online: 17 SEP 2008
- Article first published online: 20 AUG 2008
- Accepted for publication 28 May 2008
- nodular basal cell carcinoma;
- photodynamic therapy;
- randomized controlled trial
Background Skin cancer incidence rates have been increasing for decades and this increase is expected to continue. Surgical excision (SE) is the treatment of first choice for nodular basal cell carcinoma (nBCC). Photodynamic therapy (PDT) has proven to be an effective treatment for superficial basal cell carcinoma. Its long-term efficacy in nBCC has not yet been established.
Objectives Prospectively compare the efficacy of 5-aminolaevulinic acid (ALA)–PDT and SE in terms of failure rates with long-term follow-up. Determinants of failure in the study population, such as the effect of tumour depth, were analysed retrospectively.
Methods A randomized controlled trial in 173 primary nBCCs in 149 patients. Primary nBCCs were randomly assigned either to PDT (n = 85) or to SE (n = 88). Tumours treated with PDT were illuminated twice on the same day, 4 h after application of ALA cream, 3 weeks after debulking. SE was performed under local anaesthesia with a 3-mm margin, followed by histological examination. An intention-to-treat analysis was performed.
Results In total, 171 primary nBCCs in 149 patients were treated. A 3-year interim analysis revealed that the cumulative incidence of failure was 2·3% for SE and 30·3% for PDT (P < 0·001). Tumour depth and other analysed determinants of failure were not significantly related to treatment failure.
Conclusions SE proved to be significantly more effective than treatment with fractionated illumination ALA–PDT. Therefore, in the treatment of primary nBCC, SE is preferred over PDT following this treatment regimen.