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

被引:100
作者
Jansen, Maud H. E. [1 ,2 ]
Mosterd, Klara [1 ,2 ]
Arits, Aimee H. M. M. [1 ,2 ,3 ]
Roozeboom, Marieke H. [1 ,2 ]
Sommer, Anja [4 ]
Essers, Brigitte A. B. [5 ]
van Pelt, Han P. A. [6 ]
Quaedvlieg, Patricia J. F. [7 ]
Steijlen, Peter M. [1 ,2 ,3 ]
Nelemans, Patty J. [8 ]
Kelleners-Smeets, Nicole W. J. [1 ,2 ]
机构
[1] Maastricht Univ, Dept Dermatol, Med Ctr, P Debyelaan 25,POB 5800, NL-6202 AZ Maastricht, Netherlands
[2] Maastricht Univ, GROW Res Inst Oncol & Dev Biol, Maastricht, Netherlands
[3] Catharina Hosp, Dept Dermatol, Eindhoven, Netherlands
[4] Parkweg Clin Sommer, Dept Dermatol, Maastricht, Netherlands
[5] Dept Clin Epidemiol & Med Technol Assessment, Maastricht, Netherlands
[6] VieCuri Med Ctr, Dept Dermatol, Venlo, Netherlands
[7] Zuyderland Med Ctr, Dept Dermatol, Heerlen, Netherlands
[8] Maastricht Univ, Dept Epidemiol, Maastricht, Netherlands
关键词
DISCRETE-CHOICE EXPERIMENT; FOLLOW-UP; 5-PERCENT CREAM; NON-INFERIORITY; SINGLE-BLIND; SKIN-CANCER; SURGERY; FLUOROURACIL; SINS; NONINFERIORITY;
D O I
10.1016/j.jid.2017.09.033
中图分类号
R75 [皮肤病学与性病学];
学科分类号
100206 ;
摘要
For the treatment of superficial basal cell carcinoma, a prospective, noninferiority, 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 1 and 3 years after treatment. No definite conclusion could be drawn regarding the superiority of imiquimod over 5-fluorouracil. We now present the 5-year follow-up results according to the intention-to-treat analysis. Five years after treatment, the probability of tumor-free survival was 62.7% for methyl aminolevulinate photodynamic therapy (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 for treatment failure of imiquimod and 5-fluorouracil were 0.48 (95% CI = 0.32-0.71, P < 0.001) and 0.74 (95% CI = 0.53-1.05, P = 0.09), respectively, when compared with methyl aminolevulinate photodynamic therapy. Compared with 5-fluorouracil, imiquimod showed a hazard ratio of 0.65 (95% CI 0.43-0.98, P = 0.04). In conclusion, 5 years after treatment, the results of this trial show that 5% imiquimod cream is superior to both methyl aminolevulinate photodynamic therapy and 5-fluorouracil cream in terms of efficacy for superficial basal cell carcinoma. We therefore consider 5% imiquimod cream as the first choice for noninvasive treatment in most primary superficial basal cell carcinomas.
引用
收藏
页码:527 / 533
页数:7
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