At initial diagnosis, a complete TURBT is performed
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Unmet Needs in NMIBC
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At initial diagnosis, a complete TURBT is performed
6-week induction course of intravesical instillations of single-agent BCG
Maintenance therapy of 3 weekly instillations at months 3, 6, 12, 18, 24, 30, and 36
Despite decades of an established standard of care,
unmet needs still exist for patients with high-risk NMIBC.1-3
BCG=bacillus Calmette-Guérin; NMIBC=non–muscle-invasive bladder cancer; TURBT=transurethral resection of bladder tumor.
Understaging
In a systemic review of 19 trials,*
10-30%
of patients with NMIBC were initially understaged4,5
*Trials were included when they met the following criteria: at least 75 patients having high-risk NMIBC (according to European Association of Urology [EAU] guidelines: T1G3, multifocal or highly recurrent, CIS), patients were initially treated conservatively (TURBT and intravesical instillations), a median follow-up of at least 48 months, reporting data on progression to MIBC and death resulting from BCa.4
BCa=bladder cancer; CIS=carcinoma in situ; MIBC=muscle-invasive bladder cancer.
INADEQUATE Treatment
Less than 1/3 of patients are receiving adequate BCG
Real-world evidence shows that 5-year RFS, PFS, and OS rates were lowest when BCG induction/ maintenance schedules were not followed, or when patients did not receive BCG.7
OS=overall survival; PFS=progression-free survival; RFS=recurrence-free survival.
Recurrence and progression
60%
of patients with high-risk NMIBC experienced recurrence 1 year after single-agent BCG treatment.1
~20%
of patients with high-risk NMIBC may experience disease progression to MIBC within 48 months of diagnosis.1
Quality of Life Outcomes
Repeated invasive surveillance cystoscopies and intravesical treatments can be a significant patient burden.8
When a patient reaches the point of cystectomy, it can lead to other poor clinical outcomes, such as8:
30 days post cystectomy
~25%
of patients are readmitted9
90 days post cystectomy
~60%
of patients experience postoperative complications9
Postoperative complications9 |
% |
---|---|
Gastrointestinal |
29% |
Infectious |
25% |
Wound-related |
15% |
Genitourinary |
11% |
5-year relative survival based on clinical stage10*
*In situ=only in originating cells; localized=confined to primary site; regional=spread to regional lymph nodes; distant=cancer has metastasized.10
References: 1. Shore ND, Redorta JP, Robert G, et al. Non-muscle-invasive bladder cancer: an overview of potential new treatment options. Urol Oncol. 2021;39(10):642-663. 2. Holzbeierlein J, Bixler BR, Buckley DI, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment. J Urol. 2024. Published online ahead of print January 24, 2024. doi:10.1097JU.0000000000003846 3. Gontero P, Comperat E, Dominguez Escrig JL, et al. EAU guidelines on non-muscle-invasive bladder cancer (TaT1 and CIS). Presented at the EAU Annual Congress Milan. Milan, Italy; March 10-13, 2023. 4. Van den Bosch S, Witjes JA. Long-term cancer specific survival in patients with high risk non-muscle-invasive bladder cancer and tumor progression: a systematic review. Eur Urol. 2011;60(3):493-500. 5. Naselli A, Hurle R, Stefano P, et al. Role of restaging transurethral resection for T1 non-muscle invasive bladder cancer: a systematic review and meta-analysis. Eur Urol Focus. 2018;(4):558-567. 6. Kumar N, Balaji HP, Emond B, et al. Real-world treatment patterns among patients with non-muscle invasive bladder cancer (NMIBC) treated with intravesical Bacillus Calmette-Guerin (BCG). 2022 ASCO Quality Care Symposium. Accessed November 1, 2023. https://ascopubs.org/doi/10.1200/JCO.2022.40.28_suppl.404 7. Bedke J, Black PC, Szabados B, et al. Optimizing outcomes for high-risk, non-muscle-invasive bladder cancer: the evolving role of PD-(L)1 inhibition. Urol Oncol. 2023;(12):461-475. 8. Jung A, Nielsen ME, Crandell JL, et al. Health-related quality of life among non-muscle-invasive bladder cancer survivors: a population-based study. BJU Int. 2020;125(1):38-48. 9. Lenis AT, Lec PM, Chamie K. Bladder cancer: a review. JAMA. 2020;324(19):1980-1991. 10. National Cancer Institute: Surveillance, Epidemiology, and End Results Program. Cancer stat facts: bladder cancer. Accessed March 15, 2024. https://seer.cancer.gov/statfacts/html/urinb.html
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March 2024
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