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Fractionated 5-aminolevulinic acid photodynamic therapy after partial debulking versus surgical excision for nodular basal cell carcinoma: A randomized controlled trial with at least 5-year follow-up - 17/07/13

Doi : 10.1016/j.jaad.2013.02.014 
Marieke H. Roozeboom, MD a, c, , Martine A. Aardoom a, Patty J. Nelemans, MD, PhD b, Monique R.T.M. Thissen, MD, PhD a, c, Nicole W.J. Kelleners-Smeets, MD, PhD a, c, Danielle I.M. Kuijpers, MD, PhD d, Klara Mosterd, MD, PhD a, c
a Department of Dermatology, Maastricht University Medical Center, Maastricht, The Netherlands 
b Department of Epidemiology, Maastricht University Medical Center, Maastricht, The Netherlands 
c GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands 
d Department of Dermatology, Amphia Hospital, Breda, The Netherlands 

Reprint requests: Marieke H. Roozeboom, MD, Department of Dermatology, Maastricht University Medical Center, P. Debyelaan 25, PO Box 5800, 6202 AZ Maastricht, The Netherlands.

Abstract

Background

Although effective in superficial basal cell carcinoma (BCC), the treatment effect of photodynamic therapy (PDT) in nodular BCC (nBCC) is still questionable. The relation between tumor thickness and PDT failure is unclear.

Objective

We sought to compare long-term effectiveness of fractionated 20% 5-aminolevulinic acid (ALA)-PDT with prior partial debulking versus surgical excision in nBCC. The effect of tumor thickness on ALA-PDT failure was analyzed.

Methods

173 primary, histologically proven nBCCs in 151 patients were randomized to fractionated ALA-PDT (n = 85) or surgical excision (n = 88). Two PDT illuminations were performed with a 1-hour interval. Follow-up was at least 5 years posttreatment. Clinical recurrences were confirmed histologically.

Results

A total of 171 nBCCs were treated and had a median follow-up of 67 months (range 0-106). At 60 months, 23 tumors had recurred in the ALA-PDT group and 2 tumors in the surgical excision group. Cumulative recurrence probabilities 5 years posttreatment were 30.7% (95% confidence interval [CI] 21.5%-42.6%) for ALA-PDT and 2.3% (95% CI 0.6%-8.8%) for surgical excision (P < .0001). Two tumors in the ALA-PDT group recurred at 72 and 91 months posttreatment. Cumulative probability of recurrence-free survival post-PDT was 65.0% (95% CI 51%-76%) for nBCC measuring greater than 0.7 mm in thickness and 94.4% (95% CI 67%-99%, P = .018) for tumors less than or equal to 0.7 mm.

Limitations

Tumor thickness on punch biopsy specimen might differ from the total lesion thickness.

Conclusions

In nBCC, 5-year cumulative probability of recurrence after surgical excision is lower than after fractionated ALA-PDT with prior debulking. Although surgical excision remains the gold standard of treatment, PDT might be an alternative for inoperable patients with thin (≤0.7 mm) nBCC.

Le texte complet de cet article est disponible en PDF.

Key words : aminolevulinic acid, failure, nodular basal cell carcinoma, photodynamic therapy, recurrence, surgical excision, thickness, treatment

Abbreviations used : ALA, BCC, CI, MAL, nBCC, PDT, RCT


Plan


 The first 2 authors contributed equally to this work.
 Funding sources: None.
 Conflicts of interest: None declared.


© 2013  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 69 - N° 2

P. 280-287 - août 2013 Retour au numéro
Article précédent Article précédent
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