Bladder cancer prospective cohort study on high-risk non-muscle invasive bladder cancer after photodynamic diagnosis-assisted transurethral resection of the bladder tumor (BRIGHT study)

Keita Kobayashi, Hideyasu Matsuyama, Taketo Kawai, Atsushi Ikeda, Makito Miyake, Koshiro Nishimoto, Yuto Matsushita, Kazumasa Komura, Takashige Abe, Haruki Kume, Hiroyuki Nishiyama, Kiyohide Fujimoto, Masafumi Oyama, Hideaki Miyake, Keiji Inoue, Takahiko Mitsui, Mutsushi Kawakita, Chikara Ohyama, Atsushi Mizokami, Hajime Kuroiwa, Keita Kobayashi, Hideyasu Matsuyama, Taketo Kawai, Atsushi Ikeda, Makito Miyake, Koshiro Nishimoto, Yuto Matsushita, Kazumasa Komura, Takashige Abe, Haruki Kume, Hiroyuki Nishiyama, Kiyohide Fujimoto, Masafumi Oyama, Hideaki Miyake, Keiji Inoue, Takahiko Mitsui, Mutsushi Kawakita, Chikara Ohyama, Atsushi Mizokami, Hajime Kuroiwa

Abstract

Objectives: Transurethral resection of bladder tumor with photodynamic diagnosis has been reported to result in lower residual tumor and intravesical recurrence rates in non-muscle invasive bladder cancer. We aimed to evaluate the usefulness of photodynamic diagnosis-transurethral resection of bladder tumor combined with oral 5-aminolevulinic acid hydrochloride for high-risk non-muscle invasive bladder cancer.

Methods: High-risk non-muscle invasive bladder cancer patients with an initial photodynamic diagnosis-transurethral resection of bladder tumor (photodynamic diagnosis group) were prospectively registered between 2018 to 2020. High-risk non-muscle invasive bladder cancer cases with a history of initial white-light transurethral resection of bladder tumor (white-light group) were retrospectively registered. Propensity score-matching analysis was used to compare residual tumor rates, and factors that could predict residual tumors at the first transurethral resection of bladder tumor were evaluated.

Results: Analyses were conducted with 177 and 306 cases in the photodynamic diagnosis and white-light groups, respectively. The residual tumor rates in the photodynamic diagnosis and white-light groups were 25.7% and 47.3%, respectively. Factor analysis for predicting residual tumors in the photodynamic diagnosis group showed that the residual tumor rate was significantly higher in cases with a current/past smoking history, multiple tumors, and pT1/pTis. When each factor was set as a risk level of 1, cases with a total risk score ≤1 showed a significantly lower residual tumor rate than cases with a total risk score ≥2 (8.3% vs 33.3%, odds ratio 5.46 [1.81-22.28]).

Conclusions: In high-risk non-muscle invasive bladder cancer cases, the odds of a residual tumor after initial photodynamic diagnosis-transurethral resection of bladder tumor were 0.39-fold that of the odds of those after initial white-light transurethral resection of bladder tumor. A risk stratification model could be used to omit the second transurethral resection of bladder tumor in 27% of the cases.

Keywords: 5-aminolevulinic acid; bladder cancer; high-risk NMIBC; photodynamic diagnosis; second TURBT.

Conflict of interest statement

H. Matsuyama reports personal fees as meeting lecture and grants from SBI Pharmaceuticals Co., Ltd. and Chugai Pharmaceuticals Co., Ltd. H. Nishiyama reports personal fees as consultant and grants from Chugai Pharmaceuticals Co., Ltd. The funding for this study was provided by Chugai Pharmaceutical Co., Ltd. and SBI Pharmaceuticals Co., Ltd. The funding source had no role in the design, practice, or analysis of this study.

© 2022 The Authors. International Journal of Urology published by John Wiley & Sons Australia, Ltd on behalf of the Japanese Urological Association.

Figures

Fig. 1
Fig. 1
Diagram of registered research cases.
Fig. 2
Fig. 2
Residual tumor rates in the first PDD‐TURBT group (n = 167) and first WL‐TURBT group (n = 167). A significant difference test was conducted between the two groups using Fisher’s exact test. *Number in parentheses; number of residual tumor/number of patients.
Fig. 3
Fig. 3
Residual tumor rates of the sum of risk (smoking, pathological stage, number of tumors) due to clinical pathological factors at the time of the first PDD‐TURBT. The risks of current/past smoking history and pathological stage of pT1 or pTis at the time of the first PDD‐TURBT. Multiple tumors were each set to 1; the residual tumor rates of the group with a sum of risk score of ≤1 (n = 48), and the group with a sum of risk score >2 (n = 129) was analyzed with a significant difference test using Fisher’s exact test. *Number in parentheses; number of residual tumor/number of patients.

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