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Original Article
Real-world Efficacy of Intravesical Gemcitabine for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer
Hye Won Lee1orcid , Eui Hyun Jung2, Kyung Hwan Kim3, Hong Koo Ha3, Jong Jin Oh4, Seok Ho Kang5, Seung-hwan Jeong6,7, Hyeong Dong Yuk6,7, Ji Eun Heo8, Won Sik Ham8, Eu Chang Hwang9, Seung Il Jung9, Wan Song1, Bumjin Lim10, Bumsik Hong10, Byung Chang Jeong1, Ho Kyung Seo2,11,12orcid

DOI: https://doi.org/10.4143/crt.2025.100 [Accepted]
Published online: May 12, 2025
1Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2Department of Urology, Center for Urologic Cancer, National Cancer Center, Goyang, Korea
3Department of Urology, Pusan National University Hospital, Pusan National University College of Medicine, Pusan, Korea
4Department of Urology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
5Department of Urology, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea
6Department of Urology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
7Department of Urology, Seoul National University Hospital, Seoul, Korea
8Department of Urology, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea
9Department of Urology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Korea
10Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
11Division of Tumor Immunology, Research Institute and Hospital of National Cancer Center, Goyang, Korea
12Department of Cancer Biomedical Science, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Korea
Corresponding author:  Ho Kyung Seo
Tel: 82-31-920-1678 
Email: seohk@ncc.re.kr
Received: 23 January 2025   • Accepted: 11 May 2025
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Purpose
This study aimed to report the real-world outcomes of intravesical gemcitabine for bacillus Calmette–Guérin (BCG) -unresponsive, high-risk, non-muscle-invasive bladder cancer (HR-NMIBC) in Korean patients who were unable or unwilling to undergo radical cystectomy (RC).
Materials and Methods
This retrospective study included 131 patients (median age: 69 years; 89% men) treated with intravesical gemcitabine for BCG-unresponsive HR-NMIBC at nine centers between May 2019 and April 2022. The primary endpoint was 1-year recurrence-free survival (RFS). The secondary endpoints included factors influencing RFS, progression-free survival (PFS), cystectomy-free survival, cancer-specific survival (CSS), overall survival (OS), and safety. Survival analysis was performed using the Kaplan–Meier method, and risk factors for recurrence were assessed using Cox regression models.
Results
Patients were followed up for a median duration of 25 months, with carcinoma in situ (CIS) in 42% of the patients. The 1-year and 2-year RFS rates were 68% and 42%, while the 1-year and 2-year PFS rates were 87% and 77%, respectively. No significant factors influencing RFS were identified. Seventeen patients underwent RC during a median follow-up of 16 months, with the condition in three patients progressing to muscle-invasive disease on final pathological analysis. The 2-year CSS and OS rates were 98% and 97%, respectively. Intravesical gemcitabine was well-tolerated, with only 7 patients (5.3%) unable to complete the full induction course.
Conclusion
Our research highlights the potential of intravesical gemcitabine as a viable bladder-sparing treatment option for BCG-unresponsive HR-NMIBC, providing real-world evidence on its safety, efficacy, and tolerability.

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