Treatment patterns and prognosis in patients with Bacillus Calmette-Guérin-exposed high-risk non-muscle invasive bladder cancer: a real-world data analysis

Nobutaka Nishimura; Makito Miyake; Kota Iida; Tatsuki Miyamoto; Ryotaro Tomida; Kazuyuki Numakura; Junichi Inokuchi; Takahiro Yoneyama; Eijiro Okajima; Shugo Yajima; Hitoshi Masuda; Naoki Terada; Rikiya Taoka; Takashi Kobayashi; Takahiro Kojima; Yoshiyuki Matsui; Naotaka Nishiyama; Hiroshi Kitamura; Hiroyuki Nishiyama; Kiyohide Fujimoto

doi:10.1007/s00345-024-04834-4

Treatment patterns and prognosis in patients with Bacillus Calmette-Guérin-exposed high-risk non-muscle invasive bladder cancer: a real-world data analysis

World J Urol. 2024 Mar 21;42(1):185. doi: 10.1007/s00345-024-04834-4.

Authors

Nobutaka Nishimura¹, Makito Miyake², Kota Iida¹, Tatsuki Miyamoto¹, Ryotaro Tomida³, Kazuyuki Numakura⁴, Junichi Inokuchi⁵, Takahiro Yoneyama⁶, Eijiro Okajima⁷, Shugo Yajima⁸, Hitoshi Masuda⁸, Naoki Terada⁹, Rikiya Taoka¹⁰, Takashi Kobayashi¹¹, Takahiro Kojima¹², Yoshiyuki Matsui¹³, Naotaka Nishiyama¹⁴, Hiroshi Kitamura¹⁴, Hiroyuki Nishiyama¹⁵, Kiyohide Fujimoto¹

Affiliations

¹ Department of Urology, Nara Medical University, 840 Shijo-Cho, Kashihara, Nara, 634-8522, Japan.
² Department of Urology, Nara Medical University, 840 Shijo-Cho, Kashihara, Nara, 634-8522, Japan. [email protected].
³ Department of Urology, National Hospital Organization Shikoku Cancer Center, 160 Minamiumemoto-Machi Kou, Matsuyama, Ehime, 791-0280, Japan.
⁴ Department of Urology, Akita University Graduate School of Medicine, Akita, Japan.
⁵ Department of Urology, Graduate School of Medical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-Ku, Fukuoka, Fukuoka, 812-8582, Japan.
⁶ Department of Advanced Transplant and Regenerative Medicine, Hirosaki University Graduate School of Medicine, Zaifucho, Hirosaki, 036-8562, Japan.
⁷ Department of Urology, Nara Prefecture General Medical Center, 897-5, Shichijo-Nishi Machi 2 Chome, Nara, 630-8581, Japan.
⁸ Division of Urology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.
⁹ Department of Urology, Miyazaki University, 5200 Kihara Kiyotake, Miyazaki, 889-1692, Japan.
¹⁰ Department of Urology, Faculty of Medicine, Kagawa University, Kagawa, Japan.
¹¹ Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
¹² Department of Urology, Aichi Cancer Center Hospital, Kanokoden, Chikusa-Ku, Nagoya, 464-8681, Japan.
¹³ Department of Urology, National Cancer Center Hospital, Tokyo, Japan.
¹⁴ Department of Urology, Faculty of Medicine, University of Toyama, Toyama, Toyama, Japan.
¹⁵ Department of Urology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki, Japan.

PMID: 38512511
DOI: 10.1007/s00345-024-04834-4

Abstract

Purpose: The International Bladder Cancer Group designated the subgroup that is resistant to Bacillus Calmette-Guérin (BCG) but does not meet the criteria for BCG-unresponsive NMIBC as "BCG-exposed high-risk NMIBC" to guide optimal trial design. We aimed to investigate the treatment patterns and prognoses of patients with BCG-exposed NMIBC.

Methods: We conducted a retrospective chart review of 3283 patients who received intravesical BCG therapy for NMIBC at 14 participating institutions between January 2000 and December 2019. Patients meeting the criteria for BCG-exposed and BCG-unresponsive NMIBC, as defined by the Food and Drug Administration and International Bladder Cancer Group, were selected. To compare treatment patterns and outcomes, high-risk recurrence occurring more than 24 months after the last dose of BCG was defined as "BCG-treated NMIBC." In addition, we compared prognoses between BCG rechallenge and early cystectomy in patients with BCG-exposed NMIBC.

Results: Of 3283 patients, 108 (3.3%), 150 (4.6%), and 391 (11.9%) were classified as having BCG-exposed, unresponsive, and treated NMIBC, respectively. BCG-exposed NMIBC demonstrated intermediate survival curves for intravesical recurrence-free and progression-free survival, falling between those of BCG-unresponsive and treated NMIBC. Among patients with BCG-exposed NMIBC, 48 (44.4%) received BCG rechallenge, which was the most commonly performed treatment, and 19 (17.6%) underwent early cystectomy. No significant differences were observed between BCG rechallenge and early cystectomy in patients with BCG-exposed NMIBC.

Conclusions: The newly proposed definition of BCG-exposed NMIBC may serve as a valuable disease subgroup for distinguishing significant gray areas, except in cases of BCG-unresponsive NMIBC.

Keywords: Adequate BCG therapy; BCG-exposed NMIBC; BCG-unresponsive NMIBC; Delayed relapse after adequate BCG; Delayed relapse after inadequate BCG.

MeSH terms

Adjuvants, Immunologic / therapeutic use
Administration, Intravesical
BCG Vaccine / therapeutic use
Data Analysis
Humans
Neoplasm Invasiveness
Neoplasm Recurrence, Local / drug therapy
Neoplasm Recurrence, Local / epidemiology
Non-Muscle Invasive Bladder Neoplasms*
Prognosis
Retrospective Studies
Urinary Bladder Neoplasms* / drug therapy

Substances

BCG Vaccine
Adjuvants, Immunologic