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PEER-TO-PEER CLINICAL CONVERSATIONS
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BCG-Unresponsive NMIBC Treatment Options and Practical Decision-Making
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Siamak Daneshmand, MD
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| Siamak Daneshmand reviews practical treatment decision-making for patients with BCG-unresponsive NMIBC, including risk stratification, cystectomy counseling, intravesical therapy selection, treatment logistics, and the expanding role of FDA-approved bladder-preserving options such as gemcitabine intravesical drug-releasing systems.
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Challenges and Management Strategies for BCG-Unresponsive Bladder Cancer
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Patrick Hensley, MD, and Frances Martin, MD
Frances Martin and Patrick Hensley discuss BCG-unresponsive NMIBC challenges with Sam Chang. Strict BCG unresponsive definition requires adequate BCG, but only 37% of patients receive this regimen during shortages.
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CISTO Study: Patient Preferences Drive Bladder Cancer Treatment Choice, Shaping Quality of Life Outcomes
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Angela Smith, MD, MS
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| Angela Smith presents CISTO trial patient preference analysis with Sam Chang. The pragmatic study enrolled patients with recurrent high-grade NMIBC choosing bladder-sparing therapy or radical cystectomy.
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| INLEXZO™ Monotherapy in Patients with BCG-Unresponsive Papillary Disease-only, High-Risk NMIBC: 1-Year Disease-Free Survival Results from SunRISe-1
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| Siamak Daneshmand, MD
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| In a cohort of patients with BCG-unresponsive, high-grade papillary-only NMIBC, gemcitabine intravesical system (INLEXZO™, Gem-iDRS) monotherapy achieved high 1-year disease-free survival rates, with consistent results across Ta and T1 disease. Progression to muscle-invasive disease was very uncommon, and nearly all patients remained alive at 1 year, with only a small minority requiring subsequent radical cystectomy.
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| Baseline Urinary Tumor DNA, Minimal Residual Disease and Genomic Disease Burden in Relation to Clinical Response to INLEXZO™ in the Phase 2b SunRISe-1 Trial
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| Girish Kulkarni, MD, PhD
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| In an ad hoc analysis of 41 patients with BCG-unresponsive high-risk NMIBC treated with INLEXZO™ monotherapy in SunRISe-1 Cohort 2, baseline utDNA minimal residual disease (MRD) status and genomic disease burden (GDB) were not associated with patient demographics or tumor characteristics. Complete response rates were high and similar in MRD-positive and MRD-negative patients, and durability of response at 1 year was also comparable, with no significant differences in GDB between responders and non-responders.
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| Quality of Care Measures Among Patients with Recurrent, Papillary-Only Bacillus Calmette–Guérin Experienced High-Risk Non–Muscle-Invasive Bladder Cancer
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| Ali Raza Khaki, MD
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| This SEER-Medicare study of 262 BCG-experienced patients with recurrent, papillary-only high-risk NMIBC found significant gaps in quality-of-care measures, with less than half of patients receiving guideline-recommended surveillance and treatment within recommended timeframes. Notably, 46.9% underwent regular cystoscopic surveillance every three months, while substantial proportions did not receive BCG within 90 days, fail repeat TURBT within six weeks after diagnosis, or undergo cystoscopy within 120 days after TURBT.
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| Patient Preferences, Treatment Received, and Quality of Life in the CISTO Study Comparing Radical Cystectomy or Bladder Sparing Therapy for Recurrent High-Grade NMIBC
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| Angela Smith, MD, MS
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| In the CISTO pragmatic trial of 570 patients with recurrent high-grade NMIBC eligible for both radical cystectomy and bladder-sparing therapy, treatment choices were largely driven by baseline preferences for a retained versus removed bladder, with 45% preferring retention, 18% preferring removal, and 37% having no preference; those who chose cystectomy were younger, had higher certainty of cure, and were more willing to accept major surgery.
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| Impact of BCG Failure Pattern on Oncologic Outcomes of Intravesical Gemcitabine and Docetaxel in High-Risk NMIBC: A Multicenter European Study
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| Pietro Scilipoti, MD
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| This multicenter European study of 143 patients with high-risk NMIBC treated with intravesical gemcitabine + docetaxel after BCG failure found that BCG failure pattern significantly affected recurrence outcomes, with BCG-relapsing patients having lower recurrence risk compared to BCG-unresponsive and BCG-refractory cases. High-grade recurrence risks were similarly lowest in BCG-relapsing patients versus BCG-unresponsive and BCG-refractory, while progression and cystectomy rates remained low across all groups.
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| Real-World Patterns and Clinical Outcomes Among US Patients with NMIBC During the BCG Shortage
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| Suzanne Merrill, MD, FACS
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| This US real-world study of 3,516 NMIBC patients diagnosed between 2017–2022 during the BCG shortage found very low guideline-concordant treatment: only 29% of high-risk patients received BCG induction and just 12% received maintenance, with a median maintenance duration of 7.7 months. Shortage intensity and greater comorbidity burden were associated with lower initiation and higher discontinuation of maintenance therapy, and 95% of patients receiving BCG did not receive additional intravesical therapy afterward.
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