Topic: Muscle Invasive Bladder Cancer

Clinical Trials in MIBC and NMIBC

Daniel P. Petrylak, MD, discusses advancements in treating urothelial carcinoma, emphasizing innovative therapies for BCG-refractory, recurrent, and metastatic disease.

In this 10-minute talk, Petrylak highlights Dr. Neil Shore’s INSTIL trial, a significant phase 3 study evaluating the adenovirus interferon agent nadofaragene firadenovec. Dr. Petrylak also discusses how immune checkpoint inhibitors, such as pembrolizumab, are moving into early-stage treatment and combined with BCG for non-cystectomy patients.

The discussion transitions to innovative drug delivery systems, such as a “pretzel” device designed for intravesical drug release.
Dr. Petrylak shares new trials in treating metastatic carcinoma that focus on minimizing side effects linked to conventional drugs like enfortumab vedotin by introducing smaller, less immunogenic agents. These trials, including a DEVAL phase 1 dose-escalation study, underscore the importance of these targeted innovations in battling this challenging cancer.

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Current State of the Art in Bladder-Preserving Trimodality Therapy for Muscle-Invasive Bladder Cancer

Jason A. Efstathiou, MD, DPhil, FASTRO, FACRO, emphasizes the growing interest in bladder preservation therapies as an alternative to radical cystectomy for muscle-invasive bladder cancer (MIBC). While cystectomy remains an effective treatment, it is not performed in about half of eligible patients. Trimodality therapy (TMT), combining maximal transurethral resection (TUR), chemotherapy, and radiation, offers a promising bladder-sparing approach.

In this 11-minute presentation, Dr. Efstathiou compares outcomes between TMT and cystectomy, showing no significant difference in metastasis-free or cancer-specific survival. A shift toward biomarker-driven management is also highlighted, with specific markers, such as MRE11 and immune signatures, indicating better responses to chemoradiation. Immunotherapy is increasingly integrated into treatment regimens, with promising trials like SWOG 1806 exploring the addition of immune checkpoint inhibitors to chemoradiation.

TMT, now recognized by major guidelines, offers patients a viable option with preserved bladder function, improved quality of life, and less life interference. The presentation stresses the need for improved staging, expanded access to bladder-sparing options, and informed decision-making to optimize outcomes for MIBC patients.

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