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
| Autor: | Brigitte A. B. Essers, Aimee H.M.M. Arits, Klara Mosterd, Patricia J. F. Quaedvlieg, Michette J. M. De Rooij, Patty J. Nelemans, Marieke H. Roozeboom, P.M. Steijlen, Anja Sommer, Nicole W.J. Kelleners-Smeets |
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| Přispěvatelé: | MUMC+: MA AIOS Dermatologie (9), Promovendi ODB, Dermatologie, MUMC+: MA Dermatologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: KIO Kemta (9), MUMC+: MA Dermatologie (3), Epidemiologie, RS: CAPHRI - R5 - Optimising Patient Care, RS: CAPHRI - R2 - Creating Value-Based Health Care |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Skin Neoplasms Biopsy Imiquimod Subgroup analysis Antineoplastic Agents Dermatology Biochemistry Gastroenterology Disease-Free Survival law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Methyl aminolevulinate law Internal medicine parasitic diseases Carcinoma medicine Humans Basal cell carcinoma Single-Blind Method Molecular Biology Aged Proportional Hazards Models Aged 80 and over business.industry Hazard ratio Cell Biology Middle Aged medicine.disease Treatment Outcome Photochemotherapy Fluorouracil Carcinoma Basal Cell 030220 oncology & carcinogenesis Aminoquinolines Female Neoplasm Recurrence Local business medicine.drug Follow-Up Studies |
| Zdroj: | Journal of Investigative Dermatology, 136(8), 1568-1574. Elsevier Science |
| ISSN: | 0022-202X |
| DOI: | 10.1016/j.jid.2016.03.043 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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