Imiquimod vs MAL-PDT vs Effudix para Carcinoma Basocelular Superficial

A randomized controlled trial including 601 patients previously showed that the effectiveness of imiquimod and fluorouracil cream were not-inferior to methylaminolevulinate photodynamic therapy (MAL-PDT) in patients with superficial basal cell carcinoma (sBCC) after one year follow-up. We now present the three years follow-up results. The probability of tumor-free survival at three years post-treatment was 58.0% for MAL-PDT (95% CI 47.8-66.9), 79.7% for imiquimod (95% CI 71.6-85.7), and 68.2% for fluorouracil (95% CI 58.1-76.3). The hazard ratio (HR) for treatment failure comparing imiquimod with MAL-PDT was 0.50 (95% CI 0.33-0.76, p=0.001). Comparison of fluorouracil with MAL-PDT and fluorouracil with imiquimod showed HRs of 0.73 (95% CI 0.51-1.05, p=0.092) and 0.68 (95% CI 0.44-1.06, p=0.091), respectively. Subgroup analysis showed a higher probability of treatment success for imiquimod versus MAL-PDT in all subgroups with an exception of elderly patients with sBCC on lower extremities. In this latter subgroup, the risk difference in tumor-free survival was 57.6% in favor of MAL-PDT. In conclusion, according to results at three years post-treatment imiquimod is superior and fluorouracil not inferior to MAL-PDT in treatment of sBCC.

TAKE-HOME MESSAGE

• The authors of this randomized controlled trial compared the effectiveness of imiquimod, fluorouracil cream, and methyl aminolevulinate photodynamic therapy (MAL-PDT) in 601 patients with superficial basal cell carcinoma (sBCC). At 3 years' follow-up, the tumor-free survival was 58.0% for MAL-PDT, 79.7% for imiquimod, and 68.2% for fluorouracil.

• Imiquimod was superior to MAL-PDT, and fluorouracil was not inferior to MAL-PDT, for treatment of sBCC at 3 years' follow-up.

Three Year Follow-Up Results of Photodynamic Therapy Versus Imiquimod Versus Fluorouracil for Treatment of Superficial Basal Cell Carcinoma: A Single Blind, Non-Inferiority, Randomized Controlled Trial

J Invest Dermatol 2016 Apr 22;[EPub Ahead of Print], MH Roozeboom, AH Arits, K Mosterd, A Sommer, BA Essers, MJ de Rooij, PJ Quaedvlieg, PM Steijlen, PJ Nelemans, NW Kelleners-Smeets