(UroToday.com) The 2025 Western Section AUA annual meeting featured a urothelial carcinoma session and a presentation by Dr. Siamak Daneshmand discussing nurse and advanced practice provider perspectives on TAR-200 treatment of high-risk non-muscle invasive bladder cancer in the urology clinic. Non-muscle invasive bladder cancer accounts for ~70% of all bladder cancer cases, and ~50% of patients with high-risk non-muscle invasive bladder cancer experience disease recurrence or progression on BCG.
The standard of care for these patients is radical cystectomy, a life-altering surgery with a high degree of morbidity and significant impacts on quality of life. However, current treatment options for BCG-unresponsive high-risk non-muscle invasive bladder cancer CIS have limited complete response rates and response durability. For patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer with only papillary disease, there are no approved treatments.
TAR-200 is a novel intravesical targeted releasing system designed to provide sustained release of gemcitabine into the bladder. SunRISe-1 is a phase 2b study assessing gemcitabine intravesical system in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer, ineligible for/refused radical cystectomy:
At the 2025 Western Section AUA annual meeting, Dr. Daneshmand and colleagues reported data in patients with CIS ± papillary disease (Cohort 2) and patients with papillary-only disease (Cohort 4). Insights were also gathered from nurses and advanced practice providers with experience using the gemcitabine intravesical system in the urology clinic during the SunRISe-1 trial. Topics included TAR-200 insertion/removal and enhancing patient experience (including adverse event management and patient education).
TAR-200 is inserted via a urinary catheter and removed cystoscopically in 2–3 minute, in-office procedures. In the SunRISe-1 clinical trial setting, urologists perform most TAR-200 insertions/removals; however, advanced practice providers with catheter insertion and cystoscopy experience can insert/remove TAR-200, per local regulations, with minimal additional training. Nurses are often the main contacts for patients and play a key role in care coordination and education, including scheduling follow-up appointments, educating patients on treatment expectations, regular follow-up with patients post-procedure on adverse event management and self-care (ie. hydration), and coordination with advanced practice providers to prescribe medications (ie. antispasmodics, anticholinergics).
With regards to efficacy, in SunRISe-1 Cohort 2, 82.4% of patients achieved a complete response following treatment, and 52.9% of patients who responded were responsive to treatment for at least 12 months. In Cohort 4, 85.3% of patients were disease-free after 6 months, and 70.2% of patients were disease-free after 12 months. In both cohorts, most side effects were mild to moderate symptoms of the lower urinary tract (Grade 1 or 2) that were managed symptomatically and of short duration (~3 weeks):
Nurses and advanced practice providers facilitate the patient experience through patient education, coordination of care, and adverse event management:
The roles nurses and advanced practice providers play during TAR-200 treatment include (i) pre-procedure preparation, (ii) gemcitabine intravesical system insertion, (iii) follow-up, and (iv) gemcitabine intravesical system removal:
Gemcitabine intravesical system clinical management recommendations (i) in general, (ii) specific to lower urinary tract symptoms, (iii) urinary tract infections, and (iv) hematuria are highlighted in the following graphic:
Dr. Daneshmand concluded his presentation discussing nurse and advanced practice provider perspectives on TAR-200 treatment of high-risk non-muscle invasive bladder cancer in the urology clinic with the following take-home points:
- The recent approval of the gemcitabine intravesical system for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer with CIS, with or without papillary tumors, is supported by efficacy and safety data from the SunRISe-1 clinical trial
- Cohort 2 (CIS +/- papillary disease) had a high complete response rate of 82.4% and 52.9% of patients responded to treatment for at least 1 year. In Cohort 4 (papillary disease only) 85.3% and 70.2% of patients remained disease-free after 6 and 12 months, respectively
- Gemcitabine intravesical system therapy was well tolerated in SunRISe-1, with most side effects being mild to moderate symptoms of the lower urinary tract that were managed symptomatically
- Recommendations for management of adverse events include lower urinary tract symptom treatments, antibiotics, and adequate hydration
Presented by: Siamak Daneshmand, MD, Professor of Urology and Medicine (Clinical Scholar), Director of Urologic Oncology and Clinical Research, Keck School of Medicine, University of Southern California, USC Norris Comprehensive Cancer Center, Los Angeles, CA
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2025 Western Section American Urological Association (AUA) Annual Meeting, Napa Valley, CA, Sun, Nov 2 – Thurs, Nov 6, 2025.
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