Topic: Non-Muscle Invasive Bladder Cancer

NMIBC Trials for BCG Naive Patients: What is Exciting

NMIBC Trials for BCG Naive Patients: What is Exciting

by | May 2023

Joshua J. Meeks, MD, PhD, Associate Professor of Urology, Biochemistry and Molecular Genetics at the Northwestern University Feinberg School of Medicine in Chicago, IL, provides insights into the latest advancements in bladder cancer research. He highlights the potential of large-scale clinical trials and the role of immunotherapy in shaping future treatment strategies. The North American trial, with a thousand patients, offers numerous opportunities to explore new treatment modalities. Additionally, the Bridge study led by Max Kate examines the efficacy of gemcitabine docetaxel compared to the standard BCG treatment. Despite initial skepticism, the trial presents promising results that may offer an alternative for patients who cannot access BCG. Dr. Meeks emphasizes the importance of identifying the patient population that would benefit most from checkpoint immunotherapy and coordinating care effectively.

He discusses ongoing trials that investigate the synergy between immunotherapy and BCG, the possibility of using less BCG, and the introduction of a Sub-Q delivery system. The Sunrise trials, TAR 200, and the Danish study DaBlaCa all hold potential in improving treatment outcomes for bladder cancer patients. Dr. Meeks concludes by highlighting the transformative impact of the Terra system, a device that delivers gemcitabine consistently and may revolutionize bladder cancer treatment. Overall, this comprehensive summary underscores the significant advancements and future prospects in bladder cancer research.

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Risk-Adapted TURBT

Risk-Adapted TURBT

by | Feb 2023

In this 20-minute video, Seth P. Lerner, MD, Professor of Urology and Vice-chair for Faculty Affairs in the Scott Department of Urology, and Director of Urologic Oncology and the Multidisciplinary Bladder Cancer Program at Baylor University, discusses risk-adapted transurethral resection of bladder tumor (TURBT). He assesses TURBT’s role in staging and treatment and considers its use in bladder preservation.

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Bladder Sparing Tri-Modal Therapy Updates

Bladder Sparing Tri-Modal Therapy Updates

by | Feb 2023

In this 24-minute video, Daniel A. Hamstra, MD, PhD, Professor and Chair of Radiation Oncology at Baylor College of Medicine, discusses the viable but under-utilized therapy of trimodal bladder preservation. He specifically explores the role of surgery, chemotherapy, radiotherapy (RT), and check-point inhibitors in bladder sparing therapy.

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Non-Muscle Invasive Bladder Cancer: Guidelines-Based Approach

by | May 2022

Raj S. Pruthi, MD, MHA, FACS, Professor in the Department of Urology at the University of California, San Francisco, reviews the American Urological Association (AUA)-Society of Urologic Oncology (SUO) guidelines on diagnosing and treating non-muscle invasive bladder cancer (NMIBC). He begins with some statistics, relating that in 2017, there were approximately 79,000 new cases of bladder cancer, 16,800 deaths, and greater than 500,000 survivors. Dr. Pruthi observes that bladder cancer is a disease of older individuals, and he predicts that the population of bladder cancer patients will increase as the population ages. He then highlights key facts about NMIBC, explaining that most patients recur, some progress, and the ability to predict recurrence and progression is based on patient-specific disease characteristics. Dr. Pruthi introduces the 2016 AUA/SUO guidelines, noting that the panel featured a patient advocate. He goes over the guidelines point by point, starting with diagnosis. Dr. Pruthi underscores the importance of performing a complete visual transurethral resection of bladder tumor (TURBT) at initial diagnosis, explaining that incomplete TURBT is a contributing factor to early recurrences. He notes that risk calculators for NMIBC are limited by lack of applicability to current populations, and also that no study has evaluated the effectiveness of urinary biomarkers to decrease mortality or improve outcomes compared with standard diagnostic methods. When discussing guidelines around treatment, Dr. Pruthi emphasizes the importance of re-resecting T1 disease since understaging occurs in about 30% of cases and patients with residual T1 (after presumed complete resection) have up to an 80% chance of progression. He also discusses guidelines around BCG administration and BCG relapse. Dr. Pruthi then looks at cystectomy, arguing that waiting until progression to muscle invasion may prove fatal. He concludes by discussing guidelines around follow up.

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Updating the Definitions, Endpoints, and Clinical Trial Designs for Bladder Cancer

by | Apr 2022

Amirali Salmasi, MD, Assistant Professor of Urology at the University of California, San Diego, reviews risk stratification guidelines for non-muscle invasive bladder cancer (NMIBC) from the American Urological Association (AUA) and European Association of Urology (EAU); pointing out that the AUA classifies solitary high-grade (HG) Ta lesions ≤3cm classified as intermediate risk (IR-Ta) while the EAU recommends all HG tumors be classified as high-risk. Dr. Salmasi then presents data suggesting that, indeed, all HG Ta lesions should be considered high risk, supporting the EAU risk stratification model. He then reviews recommendations from the International Bladder Cancer Group, including definitions, end points, and clinical trial designs for NMIBC for both BCG-naive and BCG-unresponsive patients. For BCG-naive patients, Dr. Salmasi defines the clinically significant outcome of an absolute difference of 10 percent in the percentage of patients with recurrence at two years. For BCG-unresponsive patients with carcinoma in situ (CIS), a clinically meaningful magnitude of effect is an initial complete response rate of 50 percent at six months and a durable response rate of 30 percent at 12 months and 25 percent at 18 months; for those with papillary disease, it is a recurrence-free rate of 30 percent at 12 months and 25 percent at 18 months. Dr. Salmasi then shares information refining neoadjuvant therapy clinical trial design for muscle-invasive bladder cancer (MIBC) before cystectomy, citing level-one evidence that says neoadjuvant chemotherapy (NAC) should be offered to any “fit” patient before radical cystectomy (RC). He discusses eligibility and staging before discussing treatment options, posing questions about appropriate control arms for neoadjuvant trials as well as what number of neoadjuvant therapy cycles might be ideal, acknowledging that the best combination of treatment options remains uncertain. Dr. Salmasi discusses primary endpoints for neoadjuvant trials before shifting to a discussion on the future of trial design. He outlines some potential improvements to trial design, including sample size re-estimation; adaptive enrichment; seamless design; multi-arm, multistage (MAMS) trials; and biomarker-based adaptive study. Dr. Salmasi then outlines the benefits and limitations of MAMS trials and describes the characteristics of umbrella trials and basket trials. He discusses the BISCAY flowchart and the trial’s limitations and discusses the future of biomarker-based trial design in bladder cancer, citing two successful, meaningful biomarker-adaptive trials (PROOF 302 and IMvigor 011). Dr. Salmasi concludes by outlining future directions in the field, including ongoing trials for treatments for BCG-unresponsive NMIBC as well as neoadjuvant therapy for MIBC, where he asserts that work must be done to find the biomarkers of response, the need for improvements in molecular subtyping and treatment selection, and the need to identify optimal treatment. Finally, he asserts that improved patient outcomes would stem from an improved patient selection for radical cystectomy versus chemoradiation; there is also a need to continue to design adaptive trials to personalize treatment for those with metastatic urothelial cancer.

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When is Radical Cystectomy Indicated for NMIBC?

by | Mar 2022

Guilherme Godoy, MD, MPH, Assistant Professor of Urology at Baylor College of Medicine, in Houston, Texas, discusses the role of cystectomy in non-muscle invasive bladder cancer (NMIBC). He begins by describing the management options for NMIBC, including transurethral resection of the bladder tumor (TURBT), intravesical treatment, systemic therapy, and radical cystectomy. Dr. Godoy then explains the importance of re-TURBT, stating that it is one of the most critical steps in management for reducing understaging and improving intravesical therapy response in patients. He summarizes the indicators for cystectomy, including failure to resect, adverse pathology, and treatment failures. Dr. Godoy reviews data from a large single-institution retrospective study showing a significant difference in recurrence-free survival, cancer-specific survival, and overall survival in favor of the primary muscle invasion at presentation group vs. the progressive MIBC group. He then discusses data from a systematic review and meta-analysis of 14 studies on oncological outcomes of primary and secondary MIBC, finding worse outcomes overall for secondary muscle invasive cystectomy. Dr. Godoy looks at the European and AUA risk stratification tables, focusing on how both support aggressive management of high risk disease. He shows data from a study of the impact of variant histology on outcomes with intravesical immunotherapy, finding 40% progression-free survival compared to 17.5% in conventional bladder cancer. He states that all of this data supports cystectomy as an important and integral tool in the management of NMIBC due to its excellent oncological outcomes and potential benefit of abbreviated management and follow-up for aggressive NMIBC despite its morbidity, though the treatment may not be appropriate for everyone.

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