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CISTO: Radical cystectomy has key role in recurrent high-grade NMIBC

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Key Takeaways

  • Radical cystectomy showed improved recurrence-free survival compared to bladder-sparing therapy in recurrent high-grade NMIBC patients.
  • Patients undergoing radical cystectomy reported better global health and emotional functioning but worse urinary, sexual, and bowel quality of life.
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Twelve-month physical functioning scores were comparable between the radical cystectomy arm and the bladder-sparing therapy arm.

Radical cystectomy should continue to have an important role in the management of patients with recurrent high-grade non–muscle invasive bladder cancer (NMIBC), according to 12-month results from the CISTO study (NCT03933826).1

John L. Gore, MD, MS

John L. Gore, MD, MS

The findings were presented during the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada by John L. Gore, MD, MS, an adjunct professor of surgery at the Fred Hutchinson Cancer Center at the University of Washington in Seattle.

“We previously demonstrated in a broad survey of over 1000 patients in the Bladder Cancer Advocacy Network Patient Survey Network that the highest priority for patients with non–muscle invasive bladder cancer is to better understand how to make decisions about the timing of radical cystectomy as well as how to balance that with other treatments when their bladder cancers fail BCG,” Gore explained during the presentation. “We demonstrated in a comprehensive systematic review that limited evidence is available to help clinicians make better decisions for their patients with recurrent high-grade non–muscle invasive bladder cancer.”

To that end, the investigators launched the CISTO study to assess outcomes with intravesical therapy vs radical cystectomy in this patient population. The trial was conducted as a prospective observational cohort study.

“Our engagement with patients in the Bladder Cancer Advocacy Network informed the CISTO study design, as patient responses told us that a randomized control trial would not be feasible, given that only 11% of patients would be willing to be randomized in a comparison of radical cystectomy—a morbid, large-scale surgery—with bladder-sparing treatments.”

In total, the trial included 371 patients in the bladder-sparing therapy arm and 199 patients in the surgery arm.

Gored noted, “Our treatment groups were balanced by sex, race and ethnicity, and comorbidity burden. Patients undergoing radical cystectomy were younger, were more likely to be partnered, were less likely to live in an urban area, and had higher cancer severity as measured by a greater proportion of patients with T1 disease or concomitant CIS.”

On the study’s primary end point of 12-month physical functioning, the data showed no significant difference between the study cohorts.

Gore added, “[In] data within subgroups of patients with concomitant CIS and among individuals who were not partnered at enrollment, physical functioning was better in the radical cystectomy arm.”

Patients in the radical cystectomy arm also demonstrated improved global health compared with those in the bladder-sparing therapy arm. Additionally, patients in the radical cystectomy arm showed favorable emotional functioning scores vs those in the bladder-sparing therapy arm, which included lower levels of depression and anxiety.

Scores for financial difficulties and financial toxicity also favored the radical cystectomy arm.

Longitudinal physical functioning scores were largely comparable between both cohorts.

Gore reported, “[Our data showed] similar physical functioning at enrollment, an expected decline in physical functioning at 3 months after radical cystectomy given the large scale of the surgery, but a recovery trajectory where physical functioning is similar between treatment groups by 6 months. This was true across the entire cohort, as well as among those patients over 75 years of age, demonstrating that the finding of noninferior physical functioning held true for older CISTO study participants as well.”

However, patients who underwent radical cystectomy demonstrated worse urinary health scores compared with those who received bladder-sparing therapy. Both sexual quality of life and bowel quality of life scores were also worse among patients who underwent radical cystectomy.

Regarding clinical outcomes, data showed comparable bladder cancer-specific survival rates between the 2 arms. Specifically, the rate was 96% in the radical cystectomy arm vs 99% in the bladder-sparing therapy arm (aRR, 0.98; 95% CI, 0.96 to 1.01). However, the radical cystectomy cohort demonstrated a significant improvement in 12-month recurrence-free survival (RFS). In the radical cystectomy arm, RFS was 96%, compared with 67% in the bladder-sparing therapy arm (aRR, 0.12; 95% CI, 0.06 to 0.27).

Gore also added, “Twelve-month progression-free survival was significantly better in the bladder-sparing therapy arm, although this was mostly driven by pathologic upstaging for patients in the radical cystectomy arm.”

The CISTO study remains ongoing to assess longer-term outcomes.

“Radical cystectomy, as demonstrated by the CISTO study, has and should continue to have an important role in the management of recurrent high-grade non–muscle invasive bladder cancer,” Gore concluded during the presentation. “These are outcomes that do inform patient and clinician decision-making, and we have obtained additional NCI [National Cancer Institute] funding that will support ascertaining longer-term patient-reported and clinical outcomes.”

REFERENCE

1. Gore JL, Wolff EM, Nash MG, et al. Radical cystectomy versus bladder-sparing therapy for recurrent high-grade non-muscle invasive bladder cancer: Results from the comparison of intravesical therapy and surgery as treatment options (CISTO) study. J Urol.2025;213(5S):e3. doi:10.1097/01.JU.0001111604.90306.91.05

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