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.
A 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.
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.
Marieke H
MH
Roozeboom
Department of Dermatology, Maastricht University Medical Centre, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands; Department of Dermatology, Catharina Hospital, Eindhoven, The Netherlands.
Aimee H M M
AHMM
Arits
Department of Dermatology, Maastricht University Medical Centre, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.
Klara
K
Mosterd
Department of Dermatology, Dermatology Clinic, Maastricht, The Netherlands.
Anja
A
Sommer
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht, The Netherlands.
Brigitte A B
BAB
Essers
Department of Dermatology, VieCuri Medical Centre, Venlo, The Netherlands.
Michette J M
MJM
de Rooij
Department of Dermatology, Zuyderland Medical Centre, Heerlen, The Netherlands.
Patricia J F
PJF
Quaedvlieg
Department of Dermatology, Maastricht University Medical Centre, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands; Department of Dermatology, Catharina Hospital, Eindhoven, The Netherlands.
Peter M
PM
Steijlen
Department of Epidemiology, Maastricht University, Maastricht, The Netherlands.
Patty J
PJ
Nelemans
Department of Dermatology, Maastricht University Medical Centre, Maastricht, The Netherlands; GROW Research Institute for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.
Nicole W J
NWJ
Kelleners-Smeets
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000634:Aminoquinolines / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001706:Biopsy; D002280:Basal Cell Carcinoma / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D000077271:Imiquimod; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010778:Photochemotherapy; D016016:Proportional Hazards Models; D016037:Single-Blind Method; D012878:Skin Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
D000634:Aminoquinolines; D000970:Antineoplastic Agents; D000077271:Imiquimod; D005472:Fluorouracil