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Highlights from the 2023 ASCO Genitourinary Cancers Symposium |
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| Addressing Challenges to Ensure Health Equity in Bladder Cancer
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| Eliminating Differences in Outcomes by Race and Gender in Urothelial Carcinoma
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| Christine Ibilibor, MD
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| Christine Ibilibor discussed eliminating differences in outcomes by race and gender in urothelial carcinoma. The objectives of Dr. Ibilibor’s talk were to (i) review differences in survival outcomes based on race and gender in urothelial carcinoma, (ii) discuss multi-level factors contributing to differences in oncologic outcomes, and (iii) propose a framework for mitigating racial and gender-based disparities.
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| Addressing Health Equity by Expanding Trial Eligibility Criteria in Urothelial Carcinoma
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| Elad Sharon, MD, Ph.D.
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| Elad Sharon discussed health equity by expanding trial eligibility criteria in urothelial carcinoma. Expanding eligibility criteria on clinical trials is an essential means to improving health equity: populations on trial are noted on labels in public reports, and exclusions lead to treatment dilemmas and uncertainty.
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| The Impact of the Financial Cost: How Much Is It Costing Our Patients With Bladder Cancer?
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| Vidit Sharma, MD
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| In this presentation, Vidit Sharma presented strategies to mitigate cost and financial toxicity in bladder cancer. It is important to (i) understand the financial concerns to identify at risk patients, (ii) connect at risk patients with resources, and (iii) include financial concerns in shared-decision making.
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| It's Time to Talk About Value-Based Care and Time Toxicity With Our Patients
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| Cary Stimson, MD
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| With regards to value based care in bladder cancer, Dr. Stimson notes that there are no new ideas, just new facts, and faces. He notes that we have been talking about better ways to deliver health care for more than 70 years and there are only so many ways to do it.
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| Gender Specific Differences in Health-Related Quality of Life for Patients with Bladder Cancer Following Radical Cystectomy
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| Thilo Westhofen, MD
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| There is a known imbalance in the gender distribution of patients with newly diagnosed bladder cancer. Females undergoing radical cystectomy for bladder cancer suffer disproportionately high mortality compared to males. Gender-specific differences in HRQoL following radical cystectomy remain unknown.
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| Innovations and Multidisciplinary Care in Early- and Late-Stage Urothelial Cancer
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| Innovative and Pragmatic Methods to Study BCG Unresponsive Nonmuscle-Invasive Bladder Cancer
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| John L. Gore, MD
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| In this presentation, John Gore discussed “Why” we need a pragmatic approach to studying BCG unresponsive nonmuscle-invasive bladder cancer. |
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| A Phase II Trial of Risk-Enabled Therapy After Initiating Neoadjuvant Chemotherapy for Bladder Cancer (RETAIN)
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| Daniel M. Geynisman, MD
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| Daniel Geynisman presented results of the RETAIN Trial which hypothesized that a combination of biomarker selection and clinical staging would identify patients prospectively for a cystectomy or chemoradiation avoidance algorithm.
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| Trials in Progress: Urothelial Carcinoma |
| EV-104: Phase 1 Study of Intravesical Enfortumab Vedotin for Treatment of Patients with Non-Muscle Invasive Bladder Cancer
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| Ashish M. Kamat, MD, MBBS
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| Based on its demonstrated benefit in locally advanced/metastatic urothelial carcinoma, EV is currently being evaluated in earlier settings, such as in the neoadjuvant setting. The objective of this study is to investigate the intravesical administration of EV for patients with NMIBC.
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| A Phase II Trial of Intravesical Chemoimmunotherapy with Gemcitabine and BCG for Patients with BCG-Exposed, High-Grade, Non-Muscle–invasive Bladder Cancer
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| Christopher Gaffney, MD
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| The SOC for high-risk NMIBC after exposure to induction only BCG or relapse >12 months after “adequate” BCG is retreatment with BCG. However, ~50% of patients will relapse within 6 months. Thus, there is a critical need to develop novel combination therapies to improve BCG immunotherapy efficacy.
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| SunRISe-4: TAR-200 plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Patients with MIBC Who Are Ineligible for or Refuse Neoadjuvant Platinum-Based Chemotherapy
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| Sarah Psutka, MD, MS
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| Sarah Psutka highlighted the rationale and design of the SunRISe-4 trial, assessing TAR-200 plus cetrelimab or cetrelimab alone as neoadjuvant therapy in patients with MIBC who are unable or unwilling to receive neoadjuvant platinum-based chemotherapy.
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| Phase 3 KEYNOTE-905/EV-303: Perioperative Pembrolizumab or Pembro + Enfortumab Vedotin for Muscle-Invasive Bladder Cancer
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| Andrea Necchi, MD
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| The phase 1b/2 KEYNOTE-869/EV-103 study demonstrated promising antitumor activity in metastatic urothelial carcinoma. To further evaluate this treatment approach, authors designed the multicenter, open-label, randomized, phase 3 KEYNOTE-905 / EV-303 study.
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| A Phase 2 Basket Study of Tucatinib and Trastuzumab in Previously Treated Solid Tumors with HER2 Alterations: Urothelial Cancer Cohort (SGNTUC-019)
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| Evan Yu, MD
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| Evan Yu discussed the trial design of the urothelial cancer cohort of SGNTUC-019. The primary objective is antitumor activity, with confirmed objective response rate as the primary endpoint and disease control rate, duration of response, PFS, and OS as secondary efficacy endpoints.
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| Phase 2 KEYNOTE-057 Cohort C: Pembrolizumab with Vibostolimab or Favezelimab for Patients with High-Risk BCG-Unresponsive NMIBC
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| Neal Shore, MD, FACS
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| There is a considerable unmet clinical need for patients with high-risk BCG-unresponsive NMIBC. In cohort A of the phase 2 KEYNOTE-057 study (NCT02625961), the PD-1 inhibitor pembrolizumab showed promising antitumor activity.
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| A Phase 1, Open-Label Trial to Evaluate Feasibility and Safety of Intramural Injection of Belzupacap Sarotalocan (AU-011) in NMIBC
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| Seth Lerner, MD
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| Seth Lerner presented the design of the phase I AU-011 trial. The authors hypothesize that such a tumor targeted pro-immunogenic cell death could potentially lead to an anti-tumor immune response decreasing the risk for recurrence, progression and metastasis.
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| Randomized Phase III Clinical Trial of Neoadjuvant Intravesical Mitomycin C Treatment in Patients with Primary Treatment Naïve NMIBC
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| Massimo Lazzeri, MD
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| Massimo Lazzeri discussed this study with the primary endpoint to evaluate the efficacy of mitomycin C neoadjuvant treatment in reducing the recurrence rate of bladder cancer calculated as the proportion of patients who achieve a complete response (no evidence of bladder cancer after 3, 6, 12, and 24 months).
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| Poster Session B: Urothelial Carcinoma |
| Racial and Geographical Disparities in Pivotal Bladder Cancer Clinical Trials
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| Tiago Costa de Padua, MD, MSc
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| Given the recent influx of phase II and III trial in bladder cancer, these authors sought to assess the enrollment disparities in pivotal bladder cancer clinical trials. |
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| Baseline Characteristics from a Retrospective, Observational, US-Based, Multicenter, Real-World Study of Avelumab First-Line Maintenance in Locally Advanced/metastatic Urothelial Carcinoma (PATRIOT-II) |
| Petros Grivas, MD, PhD
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| Petros Grivas presented the initial work of PATRIOT-II. The study in progress aims to examine real-world patient characteristics, treatment patterns and clinical outcomes in an observation cohort.
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| Neoadjuvant Pembrolizumab for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer Prior to Radical Cystectomy
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| Kyle M. Rose, MD
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| Kyle Rose presented work evaluating a subset of patients in PURE-01 who were cisplatin-ineligible, and compare those receiving neoadjuvant pembrolizumab and those who went immediately to radical cystectomy at the Moffitt Cancer Center. |
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