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Systemic Therapy Advances in Muscle-Invasive Bladder Cancer: A Critical Juncture for Cisplatin-Based Trials
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Evan Yu, MD
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| Perioperative treatment for muscle-invasive bladder cancer is rapidly evolving, with NIAGARA establishing neoadjuvant gemcitabine/cisplatin plus durvalumab followed by adjuvant durvalumab as a new standard for cisplatin-eligible patients, significantly improving event-free and overall survival. For cisplatin-ineligible patients, KEYNOTE-905/EV-303 showed striking survival and pathologic complete response benefits with perioperative enfortumab vedotin plus pembrolizumab, marking the first effective systemic option for this group.
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PEER-TO-PEER CLINICAL CONVERSATIONS |
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Phase 3 KEYNOTE-905 Trial Investigates Enfortumab Vedotin Plus Pembrolizumab in Cisplatin-Ineligible Bladder Cancer
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Christof Vulsteke, MD, PhD
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| Christof Vulsteke discusses KEYNOTE-905 results with Ashish Kamat. The phase 3 trial enrolled cisplatin-ineligible muscle-invasive bladder cancer patients, median age 73, receiving perioperative enfortumab vedotin plus pembrolizumab versus control. Three cycles preceded surgery followed by six cycles EV and 14 cycles pembrolizumab.
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Health-Related Quality of Life Outcomes from the NIAGARA Trial in Bladder Cancer
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Michiel Van Der Heijden, MD, PhD
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| Michiel Van der Heijden discusses NIAGARA trial health-related quality of life outcomes, demonstrating perioperative durvalumab added to neoadjuvant chemotherapy significantly improves event-free survival and overall survival without adversely impacting patient-reported outcomes.
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Circulating Tumor DNA as Prognostic Biomarker in Perioperative Management of Muscle Invasive Bladder Cancer
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Nimira Alimohamed, MD, FRCPC
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| Ashish Kamat hosts Nimira Alimohamed to discuss the potential impact of circulating tumor DNA in muscle invasive bladder cancer management. Dr. Alimohamed reviews findings from multiple studies showing ctDNA's strong prognostic value, with detection after surgery correlating with recurrence and clearance during treatment often indicating better outcomes.
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| ctDNA for MRD Assessment in MIBC: Evidence and Evolving Practice
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| Matthew Galsky, MD
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| Matthew Galsky highlighted ctDNA as a powerful tool for minimal residual disease assessment in muscle-invasive bladder cancer, showing it reliably identifies patients who are at high risk of recurrence and likely to benefit from adjuvant immunotherapy. Data from retrospective analyses and the prospective IMvigor011 trial demonstrate that ctDNA-positive patients have worse outcomes but derive clear benefit from adjuvant treatment, while persistently ctDNA-negative patients have excellent prognoses and may safely avoid additional therapy.
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| Adjuvant Nivolumab versus Placebo for High-Risk Muscle Invasive Urothelial Carcinoma: 5-Year Follow-up Results from CheckMate-274 Including Exploratory Analyses for Muscle Invasive Bladder Cancer and ctDNA
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| Matthew Galsky, MD
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| The 5-year follow-up of CheckMate-274 confirms durable disease-free, overall, and disease-specific survival benefits with adjuvant nivolumab versus placebo in high-risk muscle-invasive urothelial carcinoma, including a clear benefit in the muscle-invasive bladder cancer subgroup regardless of prior neoadjuvant chemotherapy. Exploratory analyses showed ctDNA detectability strongly correlated with worse outcomes, with ctDNA-negative patients experiencing markedly longer DFS and OS.
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| IMvigor011: A Phase 3 Trial of ctDNA-Guided Adjuvant Atezolizumab versus Placebo in MIBC
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| Thomas Powles, MBBS, MRCP, MD
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| IMvigor011 showed that ctDNA-guided adjuvant atezolizumab significantly improved both disease-free survival and overall survival compared with placebo in ctDNA-positive patients with muscle-invasive bladder cancer after cystectomy. Patients who remained persistently ctDNA-negative had excellent outcomes without adjuvant therapy, supporting ctDNA as a powerful tool to personalize adjuvant treatment by targeting high-risk patients while safely sparing low-risk individuals.
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| CONSOLIdaTE-01: Phase II Trial of Consolidative Surgery Following Enfortumab Vedotin + Pembrolizumab in Patients with Locally Advanced/Oligometastatic Urothelial Carcinoma
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| Fady Ghali, MD
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| Fady Ghali presents CONSOLIdaTE-01, a prospective single-arm phase II trial evaluating the safety and efficacy of consolidative surgery after initial disease control with enfortumab vedotin plus pembrolizumab in patients with locally advanced or oligometastatic urothelial carcinoma. The study will assess 1-year progression-free survival, overall survival, quality of life, and ctDNA dynamics, aiming to prospectively define the role of surgery following modern systemic therapy.
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| The First Report of Disease-Free Survival Analyses from the NIAGARA Trial of Perioperative Durvalumab plus Neoadjuvant Chemotherapy in Muscle-Invasive Bladder Cancer
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| Joshua Meeks, MD, PhD
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| At AUA 2025, the phase 3 NIAGARA trial reported the first disease-free survival (DFS) results showing that perioperative durvalumab plus neoadjuvant gemcitabine/cisplatin significantly improved DFS, event-free survival, and overall survival compared with chemotherapy alone in cisplatin-eligible muscle-invasive bladder cancer. The combination increased pathologic complete response rates, reduced post-cystectomy recurrence or death by 31%, and demonstrated consistent benefit across subgroups, including patients with borderline renal function, without added surgical risk.
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