Evolving use of mitomycin solution in recurrent NMIBC

A recent Urology Times Clinical Forum discussion in Beverly Hills, California, brought together practicing urologists to explore evolving strategies in managing non–muscle invasive bladder cancer (NMIBC). Moderated by Jennifer A. Linehan, MD, the conversation focused on practical approaches to intermediate-risk disease, particularly the integration of mitomycin for intravesical solution (Zusduri), an FDA-approved chemoablative therapy. The dialogue reflected a balance between traditional surgical management and emerging nonsurgical options designed to improve patient convenience and quality of life.

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

Refining treatment for intermediate-risk NMIBC

Panelists opened the discussion by reviewing current risk stratification and how clinicians distinguish between low-, intermediate-, and high-risk NMIBC. While high-grade or multifocal tumors continue to prompt aggressive management, the group emphasized that intermediate-risk disease remains one of the most heterogeneous categories in urologic oncology.

Clinicians acknowledged that BCG shortages have accelerated the need for alternative intravesical therapies and prompted re-evaluation of how to best manage recurrent low-grade disease. Several participants noted a growing comfort level with using intravesical chemotherapy as an initial or secondary strategy, especially for patients who might otherwise face repeated anesthesia or prolonged recovery.

There was general agreement that the current therapeutic landscape allows for greater flexibility. Many urologists now tailor intensity of therapy to individual patient factors—tumor size, recurrence interval, and overall health—rather than defaulting to resection and BCG.

Initial management and recurrence patterns

Most participants continue to perform transurethral resection of bladder tumor (TURBT) as the first-line intervention for newly diagnosed NMIBC, followed by single-dose postoperative intravesical chemotherapy when feasible. Agents such as gemcitabine or mitomycin remain common selections, with some clinicians adopting sequential gemcitabine/docetaxel in select cases.

For recurrent low-grade lesions, however, many expressed interest in chemoablation as a nonsurgical alternative. Rather than routinely scheduling repeat resections, some clinicians manage small, multifocal recurrences through office-based cystoscopy and instillation therapy, reserving surgery for high-volume or high-grade disease. This approach, participants noted, reflects a broader trend toward minimizing procedural burden while maintaining oncologic control.

Integrating mitomycin for intravesical solution

Much of the conversation centered on the expanding role of mitomycin for intravesical solution, a therapy formulated to dwell in the bladder and chemoablate visible low-grade tumors. The group viewed the drug as a significant addition to the treatment armamentarium, particularly for patients with recurrent low-grade intermediate-risk NMIBC.

Panelists reviewed the clinical trial data that led to FDA approval, noting a complete response rate near 80% at 3 months and durable disease-free survival approaching 70% at 2 years among responders. Although those figures were seen as encouraging, participants emphasized that patient selection remains critical.

Ideal candidates are typically those with multifocal, small-volume, low-grade Ta tumors—particularly older adults, those with medical comorbidities, or individuals unwilling to undergo additional resections. Several clinicians reported that patients appreciate the convenience of catheter-based therapy over repeat operating room procedures, especially when comorbidities or frailty increase anesthetic risk.

Practical considerations and early experience

Participants discussed logistical aspects of administering mitomycin for intravesical solution. The 6-week instillation regimen requires careful coordination between clinical and pharmacy teams, including temperature-controlled handling and appropriate preparation time. Although some practices have already incorporated the drug into their protocols, others noted that adoption depends on institutional formulary approval and insurance coverage.

Despite these hurdles, panelists described the therapy as well tolerated, with few systemic adverse events. Local reactions, such as transient bladder irritation, were generally mild. Compared with older intravesical agents, mitomycin for intravesical solution was perceived as offering an improved patient experience due to its gel-based formulation and short in-office administration process.

Clinicians also drew parallels between this therapy and Jelmyto (mitomycin gel for upper tract disease), noting that procedural workflows and pharmacy requirements are similar. The experience with upper tract applications has, for many, eased the transition toward bladder-directed use.

Patient communication and shared decision-making

The panel agreed that patient counseling plays a pivotal role in adopting chemoablative therapy. Many patients are initially hesitant when they hear that visible tumors may not be surgically removed prior to treatment. Clinicians emphasized the need to frame the approach as targeted, localized therapy rather than inaction. Explaining that the drug directly destroys tumor tissue within the bladder helps align expectations and increase acceptance.

Participants also noted that mitomycin for intravesical solution can be particularly appealing to patients who experience anxiety around anesthesia or those who face logistical challenges with frequent operating room visits. Transparent discussions about recurrence risk and follow-up protocols are essential. The consensus was to perform cystoscopic surveillance at 3 months, followed by interval scopes every 6 to 12 months, depending on disease behavior.

Data interpretation and real-world application

The clinicians reflected on how data from pivotal trials should be interpreted in clinical context. Several commented that published Kaplan-Meier curves often represent only patients who achieved complete response, potentially overstating durability compared with broader real-world populations. Even so, the group agreed that the therapy’s efficacy and convenience justify consideration in appropriately selected cases.

Some noted that mitomycin for intravesical solution might not replace TURBT altogether but could reduce the frequency of surgical intervention and extend recurrence-free intervals. This incremental benefit, particularly in elderly patients or those with limited access to tertiary care, was seen as clinically meaningful.

Looking ahead: Research and innovation

The conversation turned to other investigational intravesical options, including drug-eluting devices such as approved gemcitabine intravesical system (Inlexzo; formerly TAR-200) and TAR-210 and viral or gene-based therapies under study. Participants viewed these innovations as evidence of an accelerating shift toward nonsurgical management for NMIBC, emphasizing quality of life and outpatient care.

The group expressed optimism that accumulating evidence and expanded access will make chemoablation a more routine element of the NMIBC treatment algorithm. However, they also highlighted ongoing challenges related to cost, reimbursement, and the need for institutional support to sustain these programs.

Closing reflections

In concluding the discussion, panelists agreed that management of NMIBC has become increasingly personalized and pragmatic, with treatment decisions guided by patient characteristics, tumor biology, and resource availability.

Mitomycin for intravesical solution was recognized as a major advancement that bridges the gap between surgery and surveillance, offering effective disease control with fewer procedural demands. As data mature and access expands, participants anticipate broader adoption of chemoablation as a key strategy for recurrent low-grade bladder cancer.

The discussion underscored how innovation in drug delivery, evidence-based selection, and shared decision-making continue to reshape the care paradigm for patients with NMIBC.