Home-Based Mitomycin Instillation Shows Promise for Low-Grade Bladder Cancer

New data published in Reviews in Urology highlights the potential for home-based instillation of intravesical mitomycin (Zusduri; formerly UGN-102) as a viable treatment option for patients with recurrent low-grade, intermediate-risk, non–muscle-invasive bladder cancer (LG-IR-NMIBC).^1,2

The phase 3b study investigated the feasibility and safety of administering the chemotherapy agent outside of traditional clinical settings, demonstrating promising efficacy and patient acceptance. The study's findings indicate that properly trained home health professionals can safely and effectively administer mitomycin using UroGen Pharma’s proprietary RTGel® technology, a sustained-release, hydrogel-based formulation. This innovation could significantly reduce the burden on both patients and healthcare systems by providing a convenient alternative to in-clinic treatments.

This is particularly relevant for the LG-IR-NMIBC patient population, which often requires ongoing management and surveillance following initial tumor removal.

“The ability to deliver this treatment safely and effectively at home has the potential to ease the burden on patients and reduce reliance on hospital or clinic resources,” said David Morris, MD, lead investigator and practicing urologist at Urology Associates, PC, Nashville, Tennessee, in a press release. “As physicians, we’re always looking for ways to provide effective care with greater comfort and convenience. These findings represent an important step in that direction.”

Of the 8 patients enrolled in the trial, 6 (75%) successfully completed all 6 scheduled treatments. At the 3-month mark, a 75% complete response (CR) rate was observed. The safety profile remained consistent with previous studies of mitomycin, with the most commonly reported adverse events being mild-to-moderate urinary symptoms. No new safety concerns emerged from the home-based administration approach.

The treatment regimen involved once-weekly instillations over a 6-week period. The initial dose was administered in a clinical setting, with the subsequent 5 doses delivered at the patient's home by a trained professional. This hybrid approach appears to balance initial clinical oversight with the practical advantages of home care. The high completion rate underscores the feasibility of this delivery model, suggesting that patients are capable and willing to adhere to the regimen in a home environment.

Patient feedback, collected through feasibility questionnaires, further supported the utility of the home-based approach. Five of the 6 patients who completed the full course of treatment indicated they would recommend this method, highlighting a strong preference for the convenience and comfort of receiving care at home. This patient-centric perspective is crucial for long-term adherence and overall quality of life in chronic disease management.

While the results are encouraging, the study acknowledged certain limitations. Its small sample size and open-label, single-arm design necessitate further research with larger, controlled trials to definitively confirm these findings and establish broader generalizability. Nevertheless, the study provides a foundational understanding of the logistical and clinical feasibility of home-instilled mitomycin for LG-IR-NMIBC.

Mitomycin for intravesical solution, utilizing the RTGel® technology, is approved for the treatment of adults with recurrent LG-IR-NMIBC following prior ineffective bladder surgery for tumor removal. The sustained-release hydrogel formulation is designed to prolong drug exposure to the bladder tissue, potentially enhancing its therapeutic effect compared to conventional liquid formulations. This innovative delivery system is central to the observed efficacy and the ability to administer the drug effectively in a home setting.

The implications of these findings extend beyond convenience. Enabling home administration could potentially improve patient access to care, particularly for those in remote areas or with mobility challenges. It may also alleviate the burden on oncology clinics, freeing up resources for other critical services. As health care systems increasingly explore models of care delivery that enhance patient autonomy and efficiency, home-based treatments for select indications like LG-IR-NMIBC could become more prevalent. The long-term impact on recurrence rates and progression, as well as the cost-effectiveness of this approach, warrant continued investigation in subsequent studies.

REFERENCES:

1. UroGen Announces Publication of Phase 3b Study Results Demonstrating the Feasibility of Home Instillation of ZUSDURI™ for Recurrent Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer in Reviews in Urology. News release. UroGen. July 28, 2025. Accessed July 28, 2025. https://tinyurl.com/4b45vzw2

2. Morris D, Kramolowsky EV, Bivins VM, et al. Home instillation of UGN-102 for primary chemoablation of recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer: a single-arm, open-label, phase 3B trial. Uro Oncol. 43, 3, 2025. doi: 10.1016/j.urolonc.2024.12.127