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Comparative Study
. 2025 Feb;135(2):260-268.
doi: 10.1111/bju.16509. Epub 2024 Aug 25.

Long-term outcomes of bladder-sparing therapy vs radical cystectomy in BCG-unresponsive non-muscle-invasive bladder cancer

Affiliations
Comparative Study

Long-term outcomes of bladder-sparing therapy vs radical cystectomy in BCG-unresponsive non-muscle-invasive bladder cancer

Jacob I Taylor et al. BJU Int. 2025 Feb.

Abstract

Objective: To quantify the oncological risks of bladder-sparing therapy (BST) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) compared to upfront radical cystectomy (RC).

Patients and methods: Pre-specified data elements were collected from retrospective cohorts of patients with BCG-unresponsive NMIBC from 10 international sites. After Institutional Review Board approval, patients were included if they had BCG-unresponsive NMIBC meeting United States Food and Drug Administration criteria. Oncological outcomes were collected following upfront RC or BST. BST regimens included re-resection or surveillance only, repeat BCG, intravesical chemotherapy, systemic immunotherapy, and clinical trials.

Results: Among 578 patients, 28% underwent upfront RC and 72% received BST. The median (interquartile range) follow-up was 50 (20-69) months. There were no statistically significant differences in metastasis-free survival, cancer-specific survival, or overall survival between treatment groups. In the BST group, high-grade recurrence rates were 37% and 52% at 12 and 24 months and progression to MIBC was observed in 7% and 13% at 12 and 24 months, respectively. RC was performed in 31.7% in the BST group and nodal disease was found in 13% compared with 4% in upfront RC (P = 0.030).

Conclusion: In a selected cohort of patients, initial BST offers comparable survival outcomes to upfront RC in the intermediate term. Rates of recurrence and progression increase over time especially in patients treated with additional lines of BST.

Keywords: BCG‐unresponsive; Bladder‐sparing therapy; intravesical therapy; radical cystectomy; urinary bladder neoplasms.

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Figures

Fig. 1
Fig. 1
Oncological outcomes of the entire cohort. Kaplan–Meier curves showing MFS (A), CSS (B), and OS (C).

References

    1. Oddens J, Brausi M, Sylvester R et al. Final results of an EORTC‐GU cancers group randomized study of maintenance bacillus Calmette‐Guerin in intermediate‐ and high‐risk Ta, T1 papillary carcinoma of the urinary bladder: one‐third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol 2013; 63: 462–472 - PubMed
    1. U.S Food and Drug Administration . BCG‐Unresponsive Nonmuscle Invasive Blader Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry. 2018. Accessed 8/1/2023. https://www.fda.gov/media/101468/download
    1. Babjuk M, Burger M, Comperat EM et al. European Association of Urology guidelines on non‐muscle‐invasive bladder cancer (TaT1 and carcinoma in situ) – 2019 update. Eur Urol 2019; 76: 639–657 - PubMed
    1. Chang SS, Boorjian SA, Chou R et al. Diagnosis and treatment of non‐muscle invasive bladder cancer: AUA/SUO guideline. J Urol 2016; 196: 1021–1029 - PubMed
    1. Stein JP, Lieskovsky G, Cote R et al. Radical cystectomy in the treatment of invasive bladder cancer: long‐term results in 1,054 patients. J Clin Oncol 2001; 19: 666–675 - PubMed

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