Efficacy of photodynamic diagnosis for non-muscle invasive bladder cancer: Exploratory subject-based analysis in a prospective, single-arm, multicenter phase III trial

IF 3.1 3区医学 Q2 ONCOLOGY

Photodiagnosis and Photodynamic Therapy Pub Date : 2025-03-12 DOI:10.1016/j.pdpdt.2025.104554

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

Abstract

Background

This analysis utilized a subject-based analysis of data from the prospective single-arm phase III trial (jRCT2061210055) to evaluate the efficacy of photodynamic diagnosis (PDD) when 5-aminolevulinic acid hydrochloride (5-ALA) was administered 4–8 h before transurethral resection of bladder tumors (TURBT).

Methods

This study evaluated 144 patients suspected of having non-muscle invasive bladder cancer (NMIBC), including 127 with NMIBC (38 patients had normal-to-flat-appearing cancer) and 17 without cancer. The diagnostic accuracy and clinical utility of blue light (BL) during TURBT were assessed for each patient and compared with those of white light (WL).

Results

Subject-based analysis revealed that WL alone missed tumor lesions in 33.1 % of patients, whereas BL alone missed 3.1 % in a biopsy-based analysis (P < 0.001). WL alone failed to diagnose NMIBC in 4.7 % of patients, while BL missed 1.6 %. Adding BL to WL led to an upgrade of NMIBC risk classification in 12 of 127 patients (9.4 %), including 5 upgraded to high-risk and 4 to highest-risk categories.

Conclusion

This study is the first to demonstrate that PDD's efficacy is maintained up to 8 h after oral 5-ALA administration and indicates that PDD improves the detection rate of bladder cancer, potentially optimizing risk stratification and offering optimal additional treatment.

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来源期刊

Photodiagnosis and Photodynamic Therapy ONCOLOGY-

CiteScore

5.80

自引率

24.20%

发文量

509

审稿时长

50 days

期刊介绍： Photodiagnosis and Photodynamic Therapy is an international journal for the dissemination of scientific knowledge and clinical developments of Photodiagnosis and Photodynamic Therapy in all medical specialties. The journal publishes original articles, review articles, case presentations, "how-to-do-it" articles, Letters to the Editor, short communications and relevant images with short descriptions. All submitted material is subject to a strict peer-review process.