Oral 5-aminolevulinic acid mediated photodynamic diagnosis using fluorescence cystoscopy for non-muscle-invasive bladder cancer: A randomized, double-blind, multicentre phase II/III study
Oral 5-aminolevulinic acid mediated photodynamic diagnosis using fluorescence cystoscopy for non-muscle-invasive bladder cancer: A randomized, double-blind, multicentre phase II/III study
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DOI：
10.1016/j.pdpdt.2015.03.008
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发表时间：
2015-06-01
影响因子：
3.3
通讯作者：
Shuin, Taro
中科院分区：
文献类型：
--
作者：
Inoue, Keiji;Anai, Satoshi;Shuin, Taro
背景资料：经尿道给予5-氨基乙酰丙酸（5-ALA）的六醛化形式（5-ALA己酯）后，非肌层浸润性膀胱癌（NMIBC）的光动力学诊断（PDD）在西方国家广泛进行。在这项研究中，5-ALA的口服给药的有效性和安全性进行了评估，在一个II/III期研究的POD为NMIBC相比，那些传统的白光endoscopic diagnosis.Methods：NMIBC患者被分配到两组，口服10和20 mg/kg的5-ALA的双盲条件下。通过将主要终点设定为敏感性来评价有效性。还分析了安全性。此外，临床推荐剂量的5-ALA也进行了调查，作为一个多中心的合作临床试验，其中5个医疗机构participated.Results：所有62例入组患者完成了临床试验。PDD的敏感性（10和20 mg/kg组分别为84.4%和75.8%）高于传统内镜诊断（分别为67.5%和47.6%）（分别为p =0.014和p< 0.001）。在4例患者中发生了5次严重不良事件;而在所有事件中排除了与研究药物的因果关系。结论：本研究启动的临床试验证实了口服5-ALA后PDD对NMIBC的有效性和安全性。两种剂量的5-ALA可能都适用于临床;然而，20 mg/kg组仅通过POD检测肿瘤的比率更高，这表明该剂量更有用。(c)2015 Elsevier B. V.版权所有。
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.