Ep. 1: NIAGARA: Shifting the Treatment Landscape in Muscle-Invasive Bladder Cancer
Key Points
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The NIAGARA trial demonstrated improved outcomes with perioperative durvalumab plus gemcitabine-cisplatin, representing a significant advance in muscle-invasive bladder cancer (MIBC) after decades of limited progress.
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Emerging data evaluating enfortumab vedotin plus pembrolizumab (EV-pembrolizumab) in the perioperative setting show promising event-free survival and pathologic complete response rates.
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As treatment options expand, clinical decision-making must balance efficacy with toxicity management.
Expanding Perioperative Therapy in Muscle-Invasive Bladder Cancer
During a recent Clinical Insights discussion cohosted by Rahul Gosain, MD, MBA, of the Wilmot Cancer Institute, and Rohit Gosain, MD, of Roswell Park Comprehensive Cancer Center, experts reviewed emerging treatment strategies for MIBC and non–muscle-invasive bladder cancer (NMIBC). Panelists included Sia Daneshmand, MD, of the Keck School of Medicine of USC; Matt Galsky, MD, of Mount Sinai; Shilpa Gupta, MD, of Cleveland Clinic; and Chad Reichard, MD, of Urology of Indiana. The discussion focused on the evolving perioperative treatment landscape, including the recently approved gemcitabine-cisplatin plus perioperative durvalumab regimen and new data evaluating EV-pembrolizumab.
Historically, patients with MIBC undergoing cystectomy—particularly those unable to receive cisplatin-based chemotherapy—had limited treatment options. According to Dr. Galsky, the emergence of new perioperative systemic therapies represents the first meaningful progress in decades. Studies evaluating perioperative approaches—including NIAGARA, which examined gemcitabine-cisplatin plus durvalumab, and trials investigating EV-pembrolizumab—demonstrated improved outcomes compared with traditional neoadjuvant chemotherapy followed by cystectomy.
Interpreting Trial Results and Clinical Considerations
The panel highlighted the importance of carefully interpreting results from separate clinical trials. Although studies evaluating perioperative durvalumab and EV-pembrolizumab share similar goals, differences in patient populations, trial design, and comparator arms limit direct comparisons across trials.
Safety considerations also remain critical when selecting treatment. As Dr. Gupta noted, clinicians have extensive experience managing toxicities associated with gemcitabine-cisplatin–based regimens, and adding durvalumab has not introduced unexpected safety concerns. In contrast, antibody–drug conjugate–based regimens such as EV-based therapy require familiarity with distinct adverse events—including rash, neuropathy, and metabolic abnormalities—which may require proactive monitoring and management.