Springer Nature
International Journal of Clinical Oncology
,  volume 30 ,  issue 1 ,  pages 110-120

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

Rikiya Taoka 1
, 
Hideo Fukuhara 2
, 
Makito Miyake 3
, 
Keita Kobayashi 4
, 
Atsushi Ikeda 5
, 
Kent Kanao 6
, 
Yoshinobu Komai 7
, 
Ryo Fujiwara 7
, 
Yusuke Sato 8
, 
Mikio Sugimoto 1
, 
Toyonori Tsuzuki 9
, 
Kiyohide Fujimoto 3
, 
Keiji Inoue 10
, 
Oya Mototsugu 11
1
 
2
 
Department of Urology, Kochi Medical School Hospital, Kochi, Japan | 
3
 
4
 
5
 
6
 
7
 
8
 
9
 
10
 
11
 
Publication type: Journal Article
Publication date: 2024-10-07
Springer Nature
scimago Q1
wos Q2
SJR: 0.936
CiteScore: 5.2
Impact factor: 2.8
ISSN: 13419625, 14377772
Abstract
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.

Found 
Found 

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GOST Copy
Taoka R. et al. 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 // International Journal of Clinical Oncology. 2024. Vol. 30. No. 1. pp. 110-120.
GOST all authors (up to 50) Copy
Taoka R., Fukuhara H., Miyake M., Kobayashi K., Ikeda A., Kanao K., Komai Y., Fujiwara R., Sato Y., Sugimoto M., Tsuzuki T., Fujimoto K., Inoue K., Mototsugu O. 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 // International Journal of Clinical Oncology. 2024. Vol. 30. No. 1. pp. 110-120.
RIS |
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RIS Copy
TY - JOUR
DO - 10.1007/s10147-024-02638-5
UR - https://link.springer.com/10.1007/s10147-024-02638-5
TI - 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
T2 - International Journal of Clinical Oncology
AU - Taoka, Rikiya
AU - Fukuhara, Hideo
AU - Miyake, Makito
AU - Kobayashi, Keita
AU - Ikeda, Atsushi
AU - Kanao, Kent
AU - Komai, Yoshinobu
AU - Fujiwara, Ryo
AU - Sato, Yusuke
AU - Sugimoto, Mikio
AU - Tsuzuki, Toyonori
AU - Fujimoto, Kiyohide
AU - Inoue, Keiji
AU - Mototsugu, Oya
PY - 2024
DA - 2024/10/07
PB - Springer Nature
SP - 110-120
IS - 1
VL - 30
PMID - 39375287
SN - 1341-9625
SN - 1437-7772
ER -
BibTex |
Cite this
BibTex (up to 50 authors) Copy
@article{2024_Taoka,
author = {Rikiya Taoka and Hideo Fukuhara and Makito Miyake and Keita Kobayashi and Atsushi Ikeda and Kent Kanao and Yoshinobu Komai and Ryo Fujiwara and Yusuke Sato and Mikio Sugimoto and Toyonori Tsuzuki and Kiyohide Fujimoto and Keiji Inoue and Oya Mototsugu},
title = {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},
journal = {International Journal of Clinical Oncology},
year = {2024},
volume = {30},
publisher = {Springer Nature},
month = {oct},
url = {https://link.springer.com/10.1007/s10147-024-02638-5},
number = {1},
pages = {110--120},
doi = {10.1007/s10147-024-02638-5}
}
MLA
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MLA Copy
Taoka, Rikiya, et al. “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.” International Journal of Clinical Oncology, vol. 30, no. 1, Oct. 2024, pp. 110-120. https://link.springer.com/10.1007/s10147-024-02638-5.