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

Document Type

Conference Proceeding

Publication Date

5-2025

Publication Title

Journal of Urology

Abstract

INTRODUCTION AND OBJECTIVE: Radical cystectomy (RC) and bladder-sparing therapy (BST) are established options for recurrent high-grade non-muscle invasive bladder cancer (NMIBC), but their comparative effectiveness is unclear. The CISTO Study aimed to address this gap in partnership with patients, clinicians, and other stakeholders. METHODS: A pragmatic, prospective observational cohort trial was conducted at US academic and community urology practices. Patients with recurrent high-grade NMIBC who were candidates for both RC and BST selected their treatment. The primary outcome was the EORTC-QLQ-C30 physical function domain at 12 months. Secondary outcomes included other EORTC-QLQ-C30 domains, depression, anxiety, generic health-related QOL, financial toxicity, bladder cancer specific QOL, and progression-free and cancer-specific survival. Outcomes were compared with targeted maximum likelihood estimation (TMLE) to calculate Average Treatment Effect (ATE) estimates between groups overall and within prespecified subgroups. Inverse probability weight-adjusted risk ratios (aRR) were calculated using quasi-Poisson regression models. RESULTS: 570 patients were enrolled at 36 sites: 371 selected BST and 199 selected RC. Physical function did not differ at 12 months between patients undergoing BST and RC (mean (SD): 85.4 (17.7) vs 86.2 (17.6), respectively; ATE 0.9 (95% CI: -0.6 to 2.4; p=0.86) overall, but favored RC among patients without a caregiver (ATE 3.3, 95% CI 0.1 to 6.4) and those with carcinoma in situ (ATE 2.7, 95% CI 0.8 to 4.7). Compared with BST, the RC arm demonstrated better 12- month outcomes in global health, emotional and cognitive function, depression, anxiety, generic health-related QOL, and financial toxicity. There were no significant differences in role and social function and urinary health, and worse outcomes in bowel and sexual health in the RC arm. Due to upstaging among 22% of patients undergoing RC, 12-month progression-free survival was lower in the RC arm (92% for BST vs 73% for RC; aRR: 0.80; 95% CI: 0.73 to 0.87); cancer specific survival did not differ (99% for BST vs 96% for RC; aRR: 0.98; 95% CI: 0.96 to 1.01). CONCLUSIONS: Most patient-prioritized outcomes were similar or better among participants who chose RC compared with BST. These findings support the continued role of RC in managing recurrent high- risk NMIBC. Ongoing follow-up will provide critical long-term outcomes.

Volume

213

Issue

5S2

First Page

e3

Last Page

e4

Comments

American Urological Association Annual Meeting, P2s: Practice-Changing Paradigm-Shifting Clinical Trials in Urology, April 26-29, 2025, Las Vegas, NV

DOI

10.1097/01.JU.0001111604.90306.91.05

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