Integrating mitomycin for intravesical solution into practice: Insights from urologists

A recent Urology Times Clinical Forum in Tampa, Florida, led by Michael Poch, MD, of Moffitt Cancer Center, brought together regional urologists to discuss the evolving management of intermediate-risk non–muscle invasive bladder cancer (NMIBC). The conversation centered on practical strategies, real-world workflow considerations, and the growing role of chemoablation therapies such as mitomycin for intravesical solution (Zusduri). Participants represented both academic and community settings.

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

Defining and managing intermediate risk

The discussion opened with a review of risk stratification and the challenges of defining high-grade Ta disease. Several clinicians noted that although guidelines help, they often diverge—particularly between the American Urological Association and European risk calculators, which weigh tumor size, multiplicity, and age differently.

Poch noted that his approach to small, solitary high-grade Ta tumors is often to treat with BCG, whereas some panelists prefer to reserve BCG for multifocal or larger-volume disease, classifying small, high-grade lesions as intermediate risk and managing them with intravesical chemotherapy instead. “I lean toward keeping BCG as a second-line option,” one participant said, citing both the limited supply and the desire to minimize overtreatment.

The group agreed that treatment selection for intermediate-risk NMIBC remains a gray area, with decisions often guided more by clinical nuance and patient factors than by strict adherence to risk tables.

Intravesical therapy and surgical practice

When asked about immediate postoperative intravesical chemotherapy, most participants said they aim to administer gemcitabine or mitomycin C after primary resection, but practice patterns vary depending on intraoperative findings. Deep resections or uncertainty about muscle involvement often prompt deferral. Several participants described the decision as a “game-time call,” made once the resection is complete and the bladder integrity can be confirmed.

Poch noted that although mitomycin C was once routine, experience with post-treatment calcifications and local irritation has shifted many practices toward gemcitabine. The group also acknowledged that experienced urologists are often good at visually differentiating low- and high-grade disease, allowing for flexible, case-by-case decisions.

Recurrent disease: Balancing observation and intervention

Case discussions focused on patients with low-grade, multifocal recurrences—a common and often frustrating presentation in practice. Panelists described a range of management approaches, from active surveillance or in-office fulguration for small papillary tumors to induction gemcitabine or sequential intravesical therapy for more frequent recurrences.

One clinician characterized many of these patients as having “nuisance tumors,” noting that although recurrence rates are high, the risk of progression remains low. “We sometimes overtreat these patients,” another added. “They’re not going to die of this disease, and our focus should be on reducing procedures and anesthesia exposure.”

The conversation also touched on workflow challenges in office-based fulguration. Some practices book patients for “cystoscopy with possible fulguration” to streamline consent and avoid repeat procedures, though logistical and billing barriers remain.

Chemoablation and the role of mitomycin for intravesical solution

The introduction of mitomycin for intravesical solution—a chemoablation therapy for low-grade, intermediate-risk NMIBC—sparked detailed discussion. Several participants had recently treated their first patients using the drug, describing it as a promising option for individuals unfit or unwilling to undergo repeat transurethral resection of the bladder tumor (TURBT) or anesthesia. The treatment involves a 6-week induction regimen delivered via catheter, with response assessed cystoscopically at 3 months.

Panelists reviewed data from the ENVISION trial, which demonstrated an approximately 80% complete response rate at 3 months and 64% to 72% 12- to 24-month disease-free survival among responders. Several clinicians admitted initial skepticism about the drug’s benefit compared with standard TURBT, but acknowledged that the durability data were more compelling than early results suggested.

“Seventy-two percent 2-year disease-free survival in a group that tends to recur frequently—that’s not bad,” one clinician said. “It makes me rethink how we can use this in select patients, especially those who want to avoid instrumentation.”

Discussions also covered the logistical hurdles of using mitomycin for intravesical solution. Hospitals and cancer centers must add it to formularies, maintain cold storage, and prepare it within short time frames. Additionally, insurance approvals require documentation of visible tumor burden, which may prompt clinicians to leave a small residual lesion for eligibility. Despite these challenges, enthusiasm for the therapy’s convenience and patient tolerance was evident.

Clinicians compared mitomycin for intravesical solution to upper tract Jelmyto use, noting similar gel consistency and chemoablation effects. “I’ve seen dramatic ablation responses where the area looks completely normal afterward,” one urologist commented.

Surveillance and de-escalation

Surveillance strategies following treatment remain highly individualized. Most clinicians perform a cystoscopy at 3 months post-treatment to assess response, then extend intervals to 6 or 12 months depending on recurrence risk.

Several noted that guidelines recommending 3-, 6-, and 9-month intervals are not strongly evidence-based. “We over-scope a lot of patients,” one participant said. “After a year of stability, it’s reasonable to de-escalate.”

The group agreed that de-escalation helps reduce procedural burden and aligns with the broader trend toward patient-centered, risk-adapted surveillance.

Expanding therapeutic landscape

Later discussion turned to the expanding list of investigational and approved options for NMIBC, including:

• gemcitabine intravesical system (Inlexzo; formerly TAR-200)

• nadofaragene firadenovec (Adstiladrin), an FDA-approved gene therapy for BCG-unresponsive disease

•oncolytic viral agents under study for intermediate- and high-risk populations.

Poch noted that Moffitt currently participates in trials involving TAR-210 and erdafitinib for FGFR3-mutated disease. Panelists expressed cautious optimism about these innovations, but also frustration with the sheer volume and pace of new treatments, which can complicate decision-making. “It’s created a black box,” one urologist said. “There are so many agents, but no clear algorithm for where each one fits.”

BCG shortages also remain a practical challenge, with many institutions rationing use for high-risk patients. The group noted that new manufacturing facilities may soon ease supply pressures.

Patient conversations and real-world realities

Participants observed that patients increasingly arrive asking for specific new treatments—sometimes demanding BCG or novel therapies like nadofaragene firadenovec or mitomycin for intravesical solution after reading about them online. Clinicians emphasized the importance of setting realistic expectations about efficacy, adverse events, and recurrence.

“There are fewer patients who say, ‘Whatever you think, doc,’” one urologist said. “Now they’ve done their own research, and it’s our job to help them interpret it.”

Despite the challenges, panelists viewed this as a positive shift toward shared decision-making and patient engagement.

Looking ahead

The group concluded with optimism that chemoablation and other minimally invasive therapies will continue to evolve as meaningful alternatives or adjuncts to surgical resection. For elderly or comorbid patients, these agents could reduce anesthesia exposure and improve quality of life.

Poch summarized the sentiment: “Our field has moved from having almost nothing for intermediate-risk disease to a broad and expanding toolkit. The key now is figuring out how to use these treatments wisely—for the right patients, at the right time.”