Experts discuss chemoablation and evolving NMIBC strategies

A recent Urology Times Clinical Forum in Washington, DC, brought together urologists, oncologists, and allied clinicians to discuss current strategies for managing non–muscle invasive bladder cancer (NMIBC), with particular attention to intermediate-risk disease and the emerging role of mitomycin for intravesical solution (formerly UGN-102, now marketed as Zusduri). The discussion, moderated by Armine K. Smith, MD, director of Johns Hopkins Urologic Oncology at Sibley Memorial Hospital and associate professor of clinical urology at Johns Hopkins University in Baltimore, Maryland, centered on guideline-based care, patient case scenarios, and the practical realities of integrating new therapies into practice.

This summary was generated by artificial intelligence and edited by humans for clarity.

Setting the Stage: Definitions and Challenges

The session began with participants reflecting on how they apply risk stratification frameworks. Most reported relying on American Urological Association (AUA) guidelines, though they noted inconsistencies across systems that make “intermediate risk” a heterogeneous category. Intermediate risk, for example, may encompass patients with recurrent low-grade tumors as well as those with multifocal disease, making clinical decision-making less straightforward.

Several clinicians observed that patients often fail to understand the distinction between NMIBC and muscle-invasive disease, complicating counseling and referrals. This confusion, combined with a rising number of available therapies, underscores the need for clear communication across specialties. Some groups are moving toward multidisciplinary clinics where urologists, oncologists, and radiation oncologists see patients with NMIBC together—a model participants suggested could help streamline care.

Case 1: Early Recurrence and Intermediate Risk

The first case discussed by the group involved a 63-year-old man with a history of low-grade NMIBC who presented with gross hematuria and multiple small recurrent tumors within 1 year of his original diagnosis. By AUA criteria, the panel agreed this patient would be classified as intermediate risk.

Clinicians emphasized that patient attitudes often shape management decisions as much as guideline categories. Some patients are resistant to intravesical therapy, preferring surveillance despite higher recurrence risks. Panelists described strategies for framing the discussion, including contrasting the inconvenience of repeated cystoscopies and transurethral resection of the bladder tumor (TURBT) with the potential benefits of intravesical therapy. One participant noted that recalling the patient’s prior surgery can make it easier to convey the value of preventive treatment. Others acknowledged that cystoscopies and catheter-based instillations remain burdensome for patients, making shared decision-making essential.

UGN-102 and the ENVISION Trial

This case led into a discussion of UGN-102, recently approved for recurrent, low-grade, intermediate-risk NMIBC based on the ENVISION trial (NCT05243550). The therapy is a mitomycin-containing hydrogel designed for chemoablation, allowing prolonged dwell time in the bladder.

Panelists reviewed trial details: 240 patients enrolled, all with prior low-grade disease; 80% of patients achieved complete response at 3 months; and roughly 80% of responders maintained durability at 1 year. Approximately 20% did not respond, 3% progressed to high-grade disease, and adverse events were common but mostly low grade. Fourteen percent experienced grade 3 or higher events, primarily urinary symptoms such as cystitis, frequency, and hematuria.

Clinician perspectives were mixed. Some saw value for patients fatigued by repeated resections or who were poor surgical candidates. Others expressed caution, citing concerns about mitomycin-related toxicity, long-lasting urinary symptoms, and the fact that the ENVISION trial was single-arm. A few questioned whether surgery may remain the easier, more tolerable path for some patients.

Access also emerged as a barrier. Institutions often take months to secure approval for new drugs, and Medicare coverage requires secondary insurance to offset cost-sharing. “It’s only realistic for patients with supplemental coverage,” 1 participant observed.

Case 2: Patient Refusal of Surgery

The second case involved a 68-year-old woman with multifocal recurrent tumors who declined another TURBT. Panelists agreed tissue confirmation remains important to exclude high-grade disease, but acknowledged that some patients simply refuse surgery. In such situations, UGN-102 could offer an alternative, though most would still counsel patients about the risks of missing an upgrade.

Office-based ablation was also discussed as an option for carefully selected patients with small recurrences. Ultimately, panelists agreed that shared decision-making is critical when balancing patient preferences with oncologic safety.

Case 3: Role of Postoperative Intravesical Therapy

The third case focused on a 68-year-old man with a single recurrent tumor. Panelists highlighted the role of postoperative intravesical chemotherapy, particularly gemcitabine. Many clinicians administer a single postoperative instillation, whereas others extend to induction or maintenance schedules.

Debate arose over sequencing: whether to escalate from gemcitabine alone to gem/doce, or to switch to BCG if available. BCG shortages continue to shape practice, with some sites able to deliver only induction therapy and not maintenance. Access to combination chemotherapy is also uneven, depending on institutional infrastructure for drug mixing and administration.

Broader Access and Implementation Challenges

Participants noted that integrating new drugs into practice often proves more complex than prescribing them. Institutional approval processes, infusion center logistics, and handling precautions for chemotherapeutic agents all present hurdles. In some centers, even standard regimens such as gem/doce can only be administered at limited sites due to safety and staffing requirements.

Financial considerations weigh heavily. UGN-102 and other novel agents are costly, with full treatment courses approaching hundreds of thousands of dollars annually. Insurers may deny coverage if strict inclusion criteria are not met, leaving practices at risk for unreimbursed costs. By contrast, gemcitabine remains inexpensive and broadly accessible, making it a preferred option in many real-world settings.

The discussion also touched on work force issues. Some institutions are exploring advanced practice provider involvement in cystoscopy, though regulatory and credentialing barriers remain. Looking ahead, participants speculated whether artificial intelligence might one day support cystoscopy in rural areas, where access to urologists is limited.

Conclusion

The Clinical Forum highlighted both progress and complexity in the management of intermediate-risk NMIBC. UGN-102 and other emerging agents provide new avenues for treatment, especially for patients unwilling or unable to undergo repeat resections. Yet, panelists emphasized that therapy must remain individualized, guided by risk stratification, patient preference, and practical realities such as access and cost.

As the therapeutic landscape expands, clinicians agreed that multidisciplinary collaboration and ongoing dialogue will be critical to delivering balanced, patient-centered care.