Real‐world use of maintenance bacillus Calmette‐Guérin therapy in patients with non‐muscle‐invasive bladder cancer in Japan: ASUKA study

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Autores principales: Makito Miyake, Jumpei Tokumaru, Hiroshi Oi, Hiroshi Kitagawa, Kiyohide Fujimoto, Naotaka Nishiyama, Hiroshi Kitamura
Formato: Artículo Open Access
Publicado: Wiley 2025
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author Makito Miyake
Jumpei Tokumaru
Hiroshi Oi
Hiroshi Kitagawa
Kiyohide Fujimoto
Naotaka Nishiyama
Hiroshi Kitamura
author_facet Makito Miyake
Jumpei Tokumaru
Hiroshi Oi
Hiroshi Kitagawa
Kiyohide Fujimoto
Naotaka Nishiyama
Hiroshi Kitamura
Makito Miyake
Jumpei Tokumaru
Hiroshi Oi
Hiroshi Kitagawa
Kiyohide Fujimoto
Naotaka Nishiyama
Hiroshi Kitamura
collection Wiley Open Access
contents Real‐world use of maintenance bacillus Calmette‐Guérin therapy in patients with non‐muscle‐invasive bladder cancer in Japan: ASUKA study Makito Miyake Jumpei Tokumaru Hiroshi Oi Hiroshi Kitagawa Kiyohide Fujimoto Naotaka Nishiyama Hiroshi Kitamura BJUI Compass Abstract Objectives To investigate the real‐world clinical use of maintenance bacillus Calmette‐Guérin (mBCG) therapy for high‐risk non‐muscle‐invasive bladder cancer (HR‐NMIBC) in Japan. Patients and methods This multicentre, retrospective, observational study included patients who received intravesical mBCG for HR‐NMIBC following transurethral resection of bladder tumours between 2000 and 2023, and who were included in the Japan Urological Oncology Group registry database. Assessments included real‐world mBCG treatment duration, the completion rate of planned treatment, reasons for treatment discontinuation and mBCG effectiveness. Results The study included 886 patients (median [interquartile range] age 71.0 [65.0–77.0] years; male, 83.5%). The median (interquartile range) treatment duration was 11 (6–17) months, with 43.8% of patients completing the physician‐determined planned treatment duration. The percentage of patients with mBCG treatment duration of 3, 6, 12, 18 and 24 months was 21.6%, 21.8%, 31.3%, 7.6% and 9.2%, respectively. Adverse events were the most common reason for mBCG discontinuation (49.1%). The recurrence‐free survival, progression‐free survival, overall survival and bladder preservation durations were numerically shorter in patients treated for 3 months. Conclusions This first comprehensive study of the real‐world use of mBCG treatment for HR‐NMIBC in Japan found diverse treatment patterns, with approximately 40% of patients receiving mBCG for <1 year, which is shorter than the guideline‐recommended treatment duration. The results underscore the need for early and sustained adverse event management, and provide valuable reference data for optimising mBCG therapy in clinical practice. 10.1002/bco2.70091 http://creativecommons.org/licenses/by/4.0/
doi_str_mv 10.1002/bco2.70091
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publishDate 2025
publisher Wiley
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spellingShingle Real‐world use of maintenance bacillus Calmette‐Guérin therapy in patients with non‐muscle‐invasive bladder cancer in Japan: ASUKA study
Makito Miyake
Jumpei Tokumaru
Hiroshi Oi
Hiroshi Kitagawa
Kiyohide Fujimoto
Naotaka Nishiyama
Hiroshi Kitamura
BJUI Compass
Real‐world use of maintenance bacillus Calmette‐Guérin therapy in patients with non‐muscle‐invasive bladder cancer in Japan: ASUKA study Makito Miyake Jumpei Tokumaru Hiroshi Oi Hiroshi Kitagawa Kiyohide Fujimoto Naotaka Nishiyama Hiroshi Kitamura BJUI Compass Abstract Objectives To investigate the real‐world clinical use of maintenance bacillus Calmette‐Guérin (mBCG) therapy for high‐risk non‐muscle‐invasive bladder cancer (HR‐NMIBC) in Japan. Patients and methods This multicentre, retrospective, observational study included patients who received intravesical mBCG for HR‐NMIBC following transurethral resection of bladder tumours between 2000 and 2023, and who were included in the Japan Urological Oncology Group registry database. Assessments included real‐world mBCG treatment duration, the completion rate of planned treatment, reasons for treatment discontinuation and mBCG effectiveness. Results The study included 886 patients (median [interquartile range] age 71.0 [65.0–77.0] years; male, 83.5%). The median (interquartile range) treatment duration was 11 (6–17) months, with 43.8% of patients completing the physician‐determined planned treatment duration. The percentage of patients with mBCG treatment duration of 3, 6, 12, 18 and 24 months was 21.6%, 21.8%, 31.3%, 7.6% and 9.2%, respectively. Adverse events were the most common reason for mBCG discontinuation (49.1%). The recurrence‐free survival, progression‐free survival, overall survival and bladder preservation durations were numerically shorter in patients treated for 3 months. Conclusions This first comprehensive study of the real‐world use of mBCG treatment for HR‐NMIBC in Japan found diverse treatment patterns, with approximately 40% of patients receiving mBCG for <1 year, which is shorter than the guideline‐recommended treatment duration. The results underscore the need for early and sustained adverse event management, and provide valuable reference data for optimising mBCG therapy in clinical practice. 10.1002/bco2.70091 http://creativecommons.org/licenses/by/4.0/
title Real‐world use of maintenance bacillus Calmette‐Guérin therapy in patients with non‐muscle‐invasive bladder cancer in Japan: ASUKA study
topic BJUI Compass
url https://bjui-journals.onlinelibrary.wiley.com/doi/10.1002/bco2.70091