3 years ago

Five-year results of a randomized controlled trial comparing effectiveness of photodynamic therapy, topical imiquimod and topical 5-fluorouracil in patients with superficial basal cell carcinoma.

Brigitte A B Essers, Marieke H Roozeboom, Peter M Steijlen, Aimee H M M Arits, Nicole W J Kelleners-Smeets, Patty J Nelemans, Maud H E Jansen, Han P A van Pelt, Patricia J F Quaedvlieg, Anja Sommer, Klara Mosterd
For the treatment of superficial basal cell carcinoma, a prospective non-inferiority randomized controlled multicenter trial with 601 patients showed that 5% imiquimod cream was superior and 5-fluorouracil cream not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) at one and three year post-treatment. No definite conclusion could be drawn regarding the superiority of imiquimod over 5-fluorouracil. We now present the five-year follow-up results according to the intention-to-treat analysis. Five years post-treatment the probability of tumor-free survival was 62.7% for MAL-PDT (95% confidence interval (CI) 55.3-69.2), 80.5% for imiquimod (95% CI 74.0-85.6), and 70.0% for 5-fluorouracil (95% CI 62.9-76.0). The hazard ratio (HR) for treatment failure of imiquimod and 5-fluorouracil were respectively 0.48 (95% CI 0.32-0.71, p<0.001) and 0.74 (95% CI 0.53-1.05, p=0.09) when compared to MAL-PDT. Compared to 5-fluorouracil, imiquimod showed a HR of 0.65 (95% CI 0.43-0.98, p=0.04). In conclusion, five years post-treatment, the results of this trial show that 5% imiquimod cream is superior to both MAL-PDT and 5-fluorouracil cream in terms of efficacy for superficial basal cell carcinoma. We therefore consider 5% imiquimod cream as the first choice non-invasive treatment in most primary superficial basal cell carcinomas.

Publisher URL: http://doi.org/10.1016/j.jid.2017.09.033

DOI: 10.1016/j.jid.2017.09.033

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