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Article Abstract
Background: A subset of non-muscle invasive bladder cancer (NMIBC) patients falls between BCG-naïve and BCG-unresponsive, leading to the introduction of the 'BCG-exposed' category. We assessed oncological outcomes in BCG-unresponsive and BCG-exposed patients undergoing bladder-sparing treatments (BST).
Methods: This retrospective study included BCG-unresponsive and BCG-exposed patients who underwent BST with BCG or a shift to different intravesical chemotherapy. Patients undergoing early RC after BCG failure (N = 14) were excluded. Kaplan-Meier (KM) curves estimated HG recurrence-free survival (HG-RFS) and progression-free survival (PFS).
Results: Among 541 patients treated with BCG from January 2005 to September 2022, 102 (19%) met inclusion criteria: 66 (65%) were classified as BCG-exposed according to IBCG criteria, 36 (35%) as BCG-unresponsive. Median follow-up from BCG-failure was 43 months (Interquartile range: 21-70). Forty-nine patients had a second HG-recurrence after BST. Of these, 8 patients progressed. No difference in KM curves was observed between the 2 groups for HG-RFS (P = 0.47) and PFS (P = 0.77). The 3-year HG-RFS after BCG treatment was 57% (95% CI: 43%-69%) for BCG-exposed and 39% (95% CI: 21%-57%) for BCG-unresponsive (HR: 1.24; 95% CI: 0.69-2.21, P = 0.47).
Conclusion: Our analysis revealed no significant differences in HG-recurrence or progression rates between BCG-exposed and BCG-unresponsive patients. Stage at the time of BCG failure recurrence, rather than the interval since the last BCG treatment, emerged as the primary factor in determining subsequent management strategies. Validation through larger-scale studies is warranted.
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| http://dx.doi.org/10.1016/j.urolonc.2025.07.004 | DOI Listing |
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Assessing oncological outcomes of bladder-sparing treatments in patients with BCG-unresponsive and BCG-exposed non-muscle-invasive bladder cancer.
Urol Oncol
July 2025
Department of Urology, IRCCS Humanitas Research Hospital, Milan, Italy.
Background: A subset of non-muscle invasive bladder cancer (NMIBC) patients falls between BCG-naïve and BCG-unresponsive, leading to the introduction of the 'BCG-exposed' category. We assessed oncological outcomes in BCG-unresponsive and BCG-exposed patients undergoing bladder-sparing treatments (BST).
Methods: This retrospective study included BCG-unresponsive and BCG-exposed patients who underwent BST with BCG or a shift to different intravesical chemotherapy.
BCG is the standard of care for non-muscle invasive high-risk bladder cancer. Notwithstanding the high rate of cure, cancer may recur. A non-muscle invasive high-risk recurrence may be defined as BCG refractory or naïve.
View Article and Find Full Text PDFLights and Shadows of Bacillus Calmette-Guérin (BCG)-exposed and BCG-unresponsive Definitions: A Practical Overview.
Eur Urol Oncol
April 2025
Department of Urology, Fundació Puigvert, Barcelona, Spain.
According to the current definitions of recurrence of non-muscle-invasive bladder cancer after bacillus Calmette-Guérin (BCG), patients in the BCG-exposed and late relapse categories might benefit from further instillations. Patients with BCG-unresponsive disease could be included in clinical trials, but otherwise radical cystectomy is the preferred treatment. BCG-intolerant disease still represents an area of debate, with limited evidence regarding the best treatment for these patients.
View Article and Find Full Text PDFTreatment 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
March 2024
Department of Urology, Nara Medical University, 840 Shijo-Cho, Kashihara, Nara, 634-8522, Japan.
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.
Introduction: The goal of this survey was to evaluate the treatment and practice pattern of patients with high-grade papillary Ta, T1 nonmuscle-invasive bladder cancer (NMIBC), and carcinoma in situ (CIS) in bacillus Calmette-Guérin (BCG)-unresponsive (with adequate BCG exposure = adequate BCG) and those with less than adequate BCG exposure (BCG-exposed).
Methods: An internet-based survey with a target duration of 5 minutes was sent to US urologists who manage patients with NMIBC. Respondents were recruited from the Sesen Bio target list based upon BCG utilization.