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
| Autor: | Marieke H. Roozeboom, Anja Sommer, Nicole W.J. Kelleners-Smeets, Han P. A. van Pelt, Brigitte A. B. Essers, Maud H.E. Jansen, Patricia J. F. Quaedvlieg, P.M. Steijlen, Aimee H.M.M. Arits, Patty J. Nelemans, Klara Mosterd |
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| Přispěvatelé: | RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Dermatologie, Promovendi ODB, MUMC+: MA Dermatologie (9), MUMC+: MA AIOS Dermatologie (9), RS: CAPHRI - R2 - Creating Value-Based Health Care, MUMC+: KIO Kemta (9), MUMC+: MA Dermatologie (3), RS: CAPHRI - R5 - Optimising Patient Care, Epidemiologie |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Skin Neoplasms SURGERY NONINFERIORITY Imiquimod Dermatology Administration Cutaneous Biochemistry SINGLE-BLIND law.invention Ointments DISCRETE-CHOICE EXPERIMENT 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Methyl aminolevulinate Randomized controlled trial law Multicenter trial medicine Carcinoma 5-PERCENT CREAM Humans Basal cell carcinoma SINS Molecular Biology Aged Aged 80 and over SKIN-CANCER business.industry Hazard ratio Aminolevulinic Acid Cell Biology Middle Aged medicine.disease FLUOROURACIL Photochemotherapy Carcinoma Basal Cell Fluorouracil 030220 oncology & carcinogenesis NON-INFERIORITY Female business FOLLOW-UP medicine.drug |
| Zdroj: | Journal of Investigative Dermatology, 138(3), 527-533. Elsevier Science |
| ISSN: | 1523-1747 0022-202X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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