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The European Association of Urology (EAU) 2026 Annual Meeting
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| BCG-Naïve NMIBC in 2025: Are We Moving Beyond BCG Alone?
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| Evanguelos Xylinas, MD, PhD, FEBU
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| Evanguelos Xylinas reviewed recent trials exploring treatment intensification for high-risk, BCG-naïve NMIBC. While the ALBAN trial found no added benefit from atezolizumab, both CREST and POTOMAC showed improved event-free and disease-free survival driven by fewer high-grade recurrences. He emphasized that two-year BCG maintenance remains essential and that combining BCG with immunotherapy offers a manageable safety profile, with benefits most likely in patients with very high-risk disease.
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| Treatment De-Intensification in NMIBC
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| Roberto Contieri, MD
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| Roberto Contieri argued that in recurrent Ta low-grade NMIBC, where prognosis is excellent but recurrences and procedures drive cost and morbidity, carefully selected patients can safely undergo treatment de-intensification with office fulguration/laser, active surveillance, or chemoablation rather than repeated TURBT.
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| Case-Based Panel Discussion High-Risk NMIBC Post-BCG Failure: High-Risk NMIBC Post-BCG Failure: Spare the Bladder? Bladder Sparing: Trial Overview ICB (Combinations)
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| Trinity Bivalacqua, MD, PhD
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| This panel used a case of very high-risk, BCG-unresponsive NMIBC to discuss when bladder-sparing strategies can be considered instead of cystectomy. They noted that while PD-1/PD-L1 plus BCG has level 1 evidence in BCG-naïve high-risk disease, in the BCG-unresponsive setting current bladder-sparing options offer modest but variable complete response durability, so future choices should emphasize long-term control, cystectomy-free survival, and overall cost–benefit.
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| Case-Based Panel Discussion High-Risk NMIBC Post-BCG Failure: Spare the Bladder? Bladder Sparing: Trial Overview Intravesical Gene Therapy (Combinations)
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| Yohann Loriot, MD, PhD
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| Yohann Loriot reviewed intravesical gene and immunotherapy combinations as promising bladder-sparing options for BCG-unresponsive, very high-risk NMIBC, focusing on agents that amplify local immune responses. He highlighted durable bladder preservation with intravesical nadofaragene firadenovec, high complete response and cystectomy-avoidance rates with N‑803 plus BCG, and encouraging long-term control with oncolytic viral therapy cretostimogene, underscoring that multiple intravesical gene-based strategies now offer credible alternatives to immediate cystectomy for carefully selected patients.
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| Case-Based Panel Discussion High-Risk NMIBC Post-BCG Failure: Spare the Bladder? Bladder Sparing: Trial Overview Other Intravesical Options
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| James Catto, PhD
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| Catto reviewed several emerging intravesical bladder-sparing options for high-risk NMIBC after BCG failure, led by TAR‑200, which in SunRISE‑1 achieved an 82.4% complete response rate in BCG‑unresponsive CIS ± papillary disease with a median response duration of about 26 months. He also highlighted TAR‑210 for FGFR‑altered NMIBC, intravesical gemcitabine–docetaxel, hyperthermic mitomycin C, and even BCG re‑challenge, noting that each can yield meaningful disease‑free survival in selected patients and should be weighed against cystectomy on durability, accessibility, and patient fitness.
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| Case-Based Panel Discussion High-Risk NMIBC Post-BCG Failure: Spare the Bladder? Cystectomy Is Still Relevant
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| Michiel Van Der Heijden, MD, PhD
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| Michiel van der Heijden emphasized that radical cystectomy remains the guideline-recommended standard for BCG‑unresponsive high‑risk NMIBC, with bladder-sparing options carrying only weak recommendations. He highlighted CISTO data showing similar survival but often better global health, emotional well‑being, and less anxiety after cystectomy versus bladder-sparing therapy, and warned that delaying surgery risks occult progression to muscle‑invasive disease, especially in patients with features like prostatic urethral involvement or T1 + CIS at last TURBT.
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| Case-Based Panel Discussion High-Risk NMIBC Post-BCG Failure: Spare the Bladder? How Do Cystectomy and Bladder Sparing Compare When We Ask Patients?
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| Kathryn Gessner, MD, PhD
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| Kathryn Gessner used the CISTO study to show that, for patients with recurrent high‑grade NMIBC after BCG, 12‑month physical functioning is similar whether they choose bladder‑sparing therapy or radical cystectomy. Radical cystectomy, however, was linked to better emotional health, less depression and anxiety, improved global quality of life, and lower financial burden, while bladder‑sparing approaches preserved better bowel and sexual function but had more recurrences and required ongoing intensive surveillance.
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| Real-World Outcomes of Bladder-sparing Strategies for BCG-Unresponsive Non-muscle Invasive Bladder Cancer: A Multicenter Study
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| Pietro Scilipoti, MD
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| Scilipoti’s multicenter retrospective study of 361 patients with BCG‑unresponsive NMIBC found that bladder‑sparing regimens with gemcitabine/docetaxel or EMDA‑MMC were associated with lower recurrence risk than additional BCG, while upfront radical cystectomy remained the guideline-standard option. Over a median 73‑month follow‑up, many patients treated with bladder‑sparing approaches avoided progression and cystectomy, but a substantial subset ultimately required radical cystectomy after high‑grade progression, underscoring that these strategies are viable alternatives mainly for those unfit for or declining surgery rather than replacements for early cystectomy in eligible patients.
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| Gemcitabine-Docetaxel Intravesical Synchronous CO-administration (G-DISCO); A First-in-human Evaluation of Synchronous Gemcitabine-Docetaxel
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| Kevin Keane, MB, BCh, BAO, MCh, MRCSi
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| This first-in-human phase I G-DISCO study showed that synchronous intravesical co‑administration of gemcitabine 1 g plus docetaxel 37.5 mg is feasible and generally well tolerated in high-risk NMIBC patients who are BCG-unresponsive or BCG-ineligible, with 93% meeting feasibility criteria and stable urinary symptom scores over treatment. At 3 months, 62% of evaluable patients achieved a complete response and high‑grade recurrence‑free survival was 77%, supporting further evaluation of this more time‑efficient synchronous strategy in the planned multinational phase II G‑DISCOTEQ trial.
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| Phase III, Single-arm Study to Evaluate the Efficacy and Safety of Intravesical Paclitaxel-Hyaluronic Acid Conjugate in Patients with BCG-unresponsive Carcinoma in Situ of the Bladder +/- Ta-T1 papillary disease (Orion-BC study)
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| Evanguelos Xylinas, MD, PhD, FEBU
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| This ongoing phase III Orion-BC study is evaluating intravesical Oncofid‑P‑B, a paclitaxel–hyaluronic acid conjugate that targets CD44 on bladder cancer cells and can boost intracellular paclitaxel delivery up to 800‑fold, in patients with BCG‑unresponsive CIS ± Ta/T1 who are unfit for or decline radical cystectomy. Early and prior phase I data show no meaningful systemic absorption, a favorable safety profile without grade 3–5 treatment-related adverse events, and promising complete response rates, and the current phase III update confirms an excellent tolerability signal to date while efficacy follow‑up continues.
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| Trial Design Drives Outcomes: Harmonizing Efficacy Across BCG-Unresponsive Bladder Carcinoma in Situ Trials
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| Daniele Robesti, MD
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| Daniele Robesti showed that complete response rates in BCG‑unresponsive CIS trials are strongly influenced by design factors like biopsy requirements, CR timing, and whether retreatment is allowed. After adjusting for immortal time and false‑negative cystoscopy/cytology, CR rates for some agents dropped, while TAR‑200’s 12‑month CR rate remained comparatively robust, highlighting that cross‑trial efficacy comparisons are unreliable without harmonized protocols.
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