延长经尿道膀胱癌切除术中从口服盐酸 5-氨基乙酰胆碱到光动力诊断的时间对诊断准确性和安全性的影响:单臂多中心 III 期试验。

IF 2.4 3区 医学 Q3 ONCOLOGY
Rikiya Taoka, Hideo Fukuhara, Makito Miyake, Keita Kobayashi, Atsushi Ikeda, Kent Kanao, Yoshinobu Komai, Ryo Fujiwara, Yusuke Sato, Mikio Sugimoto, Toyonori Tsuzuki, Kiyohide Fujimoto, Keiji Inoue, Mototsugu Oya
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引用次数: 0

摘要

背景:在日本,非肌层浸润性膀胱癌(NMIBC)口服 5-aminolevulinic acid hydrochloride (5-ALA) 与经尿道切除术之间的授权时间(2-4 h)可能会限制光动力诊断(PDD)的使用。因此,这项前瞻性、单臂 III 期研究旨在评估延长给药时间(4-8 小时)后光动力诊断的诊断准确性和安全性:方法:2022 年 1 月至 2023 年 5 月,8 家医院共招募了 161 名 NMIBC 患者。主要终点是病理阳性活检的蓝光(BL)敏感性。次要终点是比较蓝光和白光(WL)条件下的特异性以及阳性和阴性预测率:结果:共分析了 1242 份标本,包括 337 份组织学 NMIBC 标本。白光灵敏度为 95.3%。其 95% 置信区间的下限(92.4-97.3%)超过了非劣于授权使用的阈值(70%)。BL的敏感性和特异性明显高于WL(95.3% vs. 61.1%,P 结论),也低于WL(95.3% vs. 61.1%,P 结论):与 WL 相比,PDD 对 NMIBC 的长期疗效与授权疗效相似,敏感性更高,特异性更低,安全性也可以接受。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Effect of extending the period from oral administration of 5-aminolevulinic acid hydrochloride to photodynamic diagnosis during transurethral resection for non-muscle invasive bladder cancer on diagnostic accuracy and safety: a single-arm multicenter phase III trial.

Background: In Japan, the authorized period (2-4 h) between oral administration of 5-aminolevulinic acid hydrochloride (5-ALA) and transurethral resection for non-muscle invasive bladder cancer (NMIBC) may restrict photodynamic diagnosis (PDD) usage. Therefore, this prospective, single-arm, phase III study aimed to evaluate the diagnostic accuracy and safety of PDD at an extended administration period (4-8 h).

Methods: From January 2022 to May 2023, 161 patients with NMIBC were enrolled from eight hospitals. The primary endpoint was the blue light (BL) sensitivity of pathologically positive biopsies. The secondary endpoints were a comparison of the specificity and positive and negative prediction rates under BL and white light (WL) conditions.

Results: A total of 1242 specimens comprising 337 histological NMIBC specimens were analyzed. BL-sensitivity was 95.3%. Its lower limit of 95% confidence interval (92.4-97.3%) exceeded the threshold (70%) of non-inferiority to authorized usage. Sensitivity and specificity were significantly higher and lower for BL than those for WL (95.3% vs. 61.1%, P < 0.001; 52.7% vs. 95.2%, P < 0.001), respectively. The positive and negative predictive rates were significantly lower and higher for BL than those for WL (42.9% vs. 82.7%, P < 0.001; 96.8% vs. 86.8%, P < 0.001), respectively. Of the 145 patients receiving 5-ALA, 136 (93.8%) and 75 (51.7%) experienced 377 adverse events and 95 adverse reactions, respectively, most of which were grade 1 or 2.

Conclusion: For extended period, the efficacy of PDD for NMIBC was similar to that of authorized period, in terms of higher sensitivity and lower specificity compared with WL, and the safety was acceptable.

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来源期刊
CiteScore
6.80
自引率
3.00%
发文量
175
审稿时长
2 months
期刊介绍: The International Journal of Clinical Oncology (IJCO) welcomes original research papers on all aspects of clinical oncology that report the results of novel and timely investigations. Reports on clinical trials are encouraged. Experimental studies will also be accepted if they have obvious relevance to clinical oncology. Membership in the Japan Society of Clinical Oncology is not a prerequisite for submission to the journal. Papers are received on the understanding that: their contents have not been published in whole or in part elsewhere; that they are subject to peer review by at least two referees and the Editors, and to editorial revision of the language and contents; and that the Editors are responsible for their acceptance, rejection, and order of publication.
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