
Low-Grade, Intermediate-Risk NMIBC: The Hidden Lesion
Panelists discuss how UGN-102, a reverse thermal hydrogel formulation of mitomycin, offers an FDA-approved ablative treatment option for patients with intermediate-risk non-muscle invasive bladder cancer (NMIBC), demonstrating 80% complete response rates in the ENVISION trial (NCT05243550) and allowing for the de-escalation of surveillance and reduced surgical burden.
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This segment introduces the critical topic of NMIBC risk stratification, featuring leading urologic oncologists Neil Shore, MD; Katie Murray, DO, MS; Max Kates, MD; and Sam Chang, MD, MBA. The discussion focuses on the American Urological Association, European Association of Urology, and National Comprehensive Cancer Network risk stratification guidelines, which categorize NMIBC patients into 3 distinct groups: low-risk (solitary low-grade tumors ≤3cm), intermediate-risk (recurrence within first year, multifocal disease, high-grade Ta <3cm), and high-risk (high-grade T1, CIS, BCG-unresponsive disease). The intermediate-risk category represents a significant portion of the approximately 80,000 annual bladder cancer diagnoses and has historically been challenging to manage effectively.
The panel presents the case of a 62-year-old male former smoker with gross hematuria who underwent a transurethral resection of bladder tumor (TURBT), revealing low-grade Ta disease. Despite receiving 6 weeks of intravesical mitomycin C, the patient experienced recurrence at 6 months with multifocal low-grade tumors, reclassifying him as intermediate-risk. This case highlights the common clinical scenario where patients develop recurrent disease despite initial treatment, necessitating consideration of alternative therapeutic approaches beyond repeated TURBTs.
The discussion introduces UGN-102 (mitomycin gel), a recently FDA-approved reverse thermal hydrogel formulation that provides extended bladder dwell time of approximately 6 hours compared with traditional liquid chemotherapy. The ENVISION trial demonstrated an impressive 80% complete response rate in patients with recurrent low-grade NMIBC, with durable responses lasting up to 18 months. This breakthrough therapy offers a paradigm shift from surgical intervention to chemoablation, potentially reducing the burden of repeated TURBTs while maintaining excellent efficacy and tolerability profiles for patients with intermediate-risk NMIBC.
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