Surgery and Bladder-Sparing Therapy May Offer Comparable Early Outcomes in NMIBC

In the observational CISTO study (NCT03933826) of patients with recurrent high-grade non–muscle invasive bladder cancer (NMIBC), patient-reported and clinical outcomes were found to be similar between those who received radical cystectomy (RC) and bladder-sparing therapy (BST) after 1 year, suggesting the potential feasibility of either approach without compromising early outcomes.¹

Results published in the Journal of Clinical Oncology show that patients who received RC and BST had similar physical function by 12 months. While patients receiving RC had significantly worse physical function early on at 3 months compared with those receiving BST, this difference disappeared by 9 months; at 12 months, the average treatment effect was estimated at 0.9 (95% CI, –0.6–2.4; P =.22). However, the RC arm also had significantly worse sexual and bowel function at 12 months than the BST arm.

Additionally, RC was found to be associated with improved emotional and cognitive function, general health-related quality of life (QOL), and lower anxiety and depression compared with BST. Meanwhile, BST was associated with significantly higher financial toxicities than RC.

Regarding clinical outcomes, patients receiving RC had slightly reduced cancer-specific survival than patients receiving BST, but this difference was not significant (96% vs 99%; weighted risk ratio, 0.99; 95% CI, 0.97–1.01). Compared with BST, RC was also associated with a significantly higher risk of adverse events (AEs; 62% vs 38%) as well as serious AEs and inpatient hospitalizations.

The study’s findings offer key considerations for shared decision-making between patients and providers when deciding whether to retain the bladder, which can ultimately give rise to more personalized, patient-centered care. As NMIBC can be a debilitating and costly cancer to treat, both clinical and QOL outcomes must be carefully weighed when selecting an optimal treatment approach. The authors concluded that the findings reinforce the continued role of RC in treating NMIBC, which can offer comparable outcomes and a more cost-effective option for certain patients.

“Based on these findings, the role of [RC] and bladder-saving strategies and their impact on [QOL] outcomes need further discussion in patient-centric strategies,” Andrea Necchi, MD, Journal of Clinical Oncology associate editor, commented in the publication.¹

Study Design and Patient Population

To help reduce treatment decision uncertainty in NMIBC, the CISTO study was designed as a prospective comparative effectiveness study to compare the QOL and clinical impact of RC vs BST in patients with recurrent high-grade NMIBC who had failed Bacillus Calmette-Guérin (BCG) induction therapy.²

Outcomes were selected and prioritized by patients. The primary outcome of the study was 12-month patient-reported physical function, as measured with the EORTC QLQ-C30 physical functioning scale. Secondary patient-prioritized outcomes included other EORTC QLQ-C30 scales (global health status, emotional, cognitive, and social functioning) and symptoms of financial difficulties. Secondary clinical outcomes included 12-month recurrence-free, progression-free, metastasis-free, cancer-specific, and overall survival

The total cohort included 570 adult patients from across 36 sites in the US, 199 of whom opted for RC and 371 BST. The cohort was older (mean age, 71.4 years) and predominantly White (92%); patient characteristics were reported to be similar between arms.

Patients were included if they were eligible for both RC or BST, had previous induction intravesical BCG, and received their last treatment within the past 12 months. Key exclusion criteria included having previous history of cystectomy or radiation therapy for bladder cancer, muscle-invasive bladder cancer or metastatic bladder cancer, or upper tract urothelial carcinoma.

REFERENCES

1. Gore JL, Wolff EM, Nash MG, et al. Twelve-month results from the CISTO study comparing radical cystectomy versus bladder-sparing therapy for recurrent high-grade non–muscle-invasive bladder cancer. J Clin Oncol. Published online December 15, 2025. doi:10.1200/jco-25-01324

2. CISTO: comparison of intravesical therapy and surgery as treatment options for bladder cancer (CISTO). ClinicalTrials.gov. Updated November 4, 2025. Accessed January 2, 2026. https://www.clinicaltrials.gov/study/NCT03933826