• J. Invest. Dermatol. · Aug 2016

    Randomized Controlled Trial

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

    • Marieke H Roozeboom, Arits Aimee H M M AHMM Department of Dermatology, Maastricht University Medical Centre, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmenta, Klara Mosterd, Anja Sommer, Essers Brigitte A B BAB Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht, The Netherlands., Michette J M de Rooij, Quaedvlieg Patricia J F PJF Department of Dermatology, Zuyderland Medical Centre, Heerlen, The Netherlands., Peter M Steijlen, Patty J Nelemans, and Kelleners-Smeets Nicole W J NWJ Department of Dermatology, Maastricht University Medical Centre, Maastricht, The Netherlands; GROW Research Institute for Oncology and Dev.
    • Department of Dermatology, Maastricht University Medical Centre, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands. Electronic address: mh.roozeboom@mumc.nl.
    • J. Invest. Dermatol. 2016 Aug 1; 136 (8): 1568-1574.

    AbstractA randomized controlled trial including 601 patients previously showed that the effectiveness of imiquimod and fluorouracil cream were not inferior to methyl aminolevulinate photodynamic therapy (MAL-PDT) in patients with superficial basal cell carcinoma after 1 year of follow-up. We now present the 3-year follow-up results. The probability of tumor-free survival at 3 years post-treatment was 58.0% for MAL-PDT (95% confidence interval [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 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 hazard ratios 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 the exception of elderly patients with superficial basal cell carcinoma on the lower extremities. In this subgroup, the risk difference in tumor-free survival was 57.6% in favor of MAL-PDT. In conclusion, according to results at 3 years post-treatment, imiquimod is superior and fluorouracil not inferior to MAL-PDT in treatment of superficial basal cell carcinoma.Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

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