期刊
PHOTODIAGNOSIS AND PHOTODYNAMIC THERAPY
卷 12, 期 2, 页码 193-200出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.pdpdt.2015.03.008
关键词
Randomized clinical trial; Photodynamic diagnosis; 5-Aminolevulinic acid; Non-muscle-invasive bladder cancer; Oral administration
类别
资金
- Japan Medical Association
- Ministry of Health, Labour and Welfare Research Grant [CCT-A-2204, CCT-B-2302, CCT-C-2331-2335]
Background: Photodynamic diagnosis (PDD) of non-muscle-invasive bladder cancer (NMIBC) following transurethral administration of a hexalated form of 5-aminolevulinic acid (5-ALA), 5-ALA hexyl ester, is widely performed in Western countries. In this study, effectiveness and safety of the oral administration of 5-ALA is assessed in a phase II/III study of POD for NMIBC in comparison to those of conventional white-light endoscopic diagnosis. Methods: Patients with NMIBC were allocated to two groups that were orally administered 10 and 20 mg/kg of 5-ALA under the double-blind condition. Effectiveness was evaluated by setting the primary endpoint to sensitivity. Safety was also analyzed. Moreover, clinically recommended doses of 5-ALA was also investigated as an investigator-initiated multicenter cooperative clinical trial in which five medical institutions participated. Results: All 62 enrolled patients completed the clinical trial. The sensitivities of PDD were higher (84.4 and 75.8% in the 10 and 20 mg/kg-groups, respectively) than those of conventional endoscopic diagnosis (67.5 and 47.6%, respectively) (p =0.014 and p< 0.001, respectively). Five episodes of serious adverse events developed in four patients; whereas a causal relationship with the investigational agent was ruled out in all episodes. Conclusion: This investigator-initiated clinical trial confirmed the effectiveness and safety of PDD for NMIBC following oral administration of 5-ALA. Both doses of 5-ALA may be clinically applicable; however, the rate of detecting tumors only by POD was higher in the 20 mg/kg-group suggesting that this dose would be more useful. (c) 2015 Elsevier B.V. All rights reserved.
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