Oncological Outcomes for Patients with European Association of Urology Very High-risk Non-muscle-Invasive Bladder Cancer Treated with Bacillus Calmette-Guérin or Early Radical Cystectomy

Roberto Contieri; Patrick J Hensley; Wei Shen Tan; Valentina Grajales; Kelly Bree; Graciela M Nogueras-Gonzalez; Byron H Lee; Neema Navai; Colin P Dinney; Ashish M Kamat

doi:10.1016/j.euo.2023.07.012

Oncological Outcomes for Patients with European Association of Urology Very High-risk Non-muscle-Invasive Bladder Cancer Treated with Bacillus Calmette-Guérin or Early Radical Cystectomy

Eur Urol Oncol. 2023 Dec;6(6):590-596. doi: 10.1016/j.euo.2023.07.012. Epub 2023 Aug 8.

Affiliations

¹ Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
² Department of Urology, University of Kentucky, Lexington, KY, USA.
³ Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁴ Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁵ Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: akamat@mdanderson.org.

PMID: 37558542
DOI: 10.1016/j.euo.2023.07.012

Abstract

Background: European Urology Association (EAU) guidelines recommend immediate radical cystectomy (early RC) for patients with very high-risk (VHR) non-muscle invasive bladder cancer (NMIBC), with bacillus Calmette-Guérin (BCG) recommended only for those who refuse or are unfit for RC.

Objective: To describe oncological outcomes following BCG or early RC in a contemporary cohort of patients with VHR NMIBC (EAU criteria).

Design, setting, and participants: Patients diagnosed with VHR NMIBC between 2000 and 2020 were identified from our institutional NMIBC registry.

Outcome measurements and statistical analysis: The primary outcomes were overall survival (OS) and cancer-specific mortality (CSM). Secondary outcomes were the progression rate and high-grade recurrence (HGR) rate for patients receiving BCG.

Results and limitations: We identified 235 patients with VHR NMIBC, of whom 157 (67%) received BCG and 78 (33%) underwent early RC. The median follow-up was 52.8 mo. OS and CSM rates were 80.2% and 5.3% in the BCG group, and 88.1% and 4.9% in the early RC group, respectively with no significant difference in OS (p = 0.6) or CSM (p = 0.8) between the two groups. Among the patients treated with BCG, 5-yr HGR and progression rates were 41.9% and 17.4%, respectively; 39 patients (25%) underwent delayed RC after BCG. No significant difference in CSM emerged when comparing patients treated with delayed RC (after BCG) with those undergoing early RC (p = 0.86).

Conclusions: Our findings suggest that intravesical BCG can be offered to patients as a resonable alternative to early RC for selected patients with VHR NMIBC.

Patient summary: We evaluated outcomes for patients with very high-risk non-muscle-invasive bladder cancer (NMIBC) treated with BCG (bacillus Calmette-Guérin) versus early surgical removal of the bladder and found no differences in survival. We conclude that BCG could be offered to selected patients with this type of bladder cancer as a reasonable alternative to early bladder removal.

Keywords: Bacillus Calmette-Guerin; Intravesical; Non-muscle invasive bladder cancer; Radical cystectomy; Very high risk.

MeSH terms

Adjuvants, Immunologic
BCG Vaccine / therapeutic use
Cystectomy
Humans
Non-Muscle Invasive Bladder Neoplasms*
Urinary Bladder
Urinary Bladder Neoplasms* / drug therapy
Urinary Bladder Neoplasms* / surgery
Urology*

Substances

BCG Vaccine
Adjuvants, Immunologic