Comparative Analysis of Very Reduced vs Full Dose BCG Treatment for High-Risk Non-Muscle Invasive Bladder Cancer: A Contemporary Experience from Chile

Journal
Bladder Cancer
ISSN
2352-3727
2352-3735
Date Issued
2023
Author(s)
Valentina Grajales
Roberto Contieri
Wei Shen Tan
Marta Flores
Marcela Schultz
Rodrigo Pinochet
Alberto Bustamante
Ashish M. Kamat
Mario I. Fernández
Type
journal-article
Scopus ID
2-s2.0-85180341802
WoS ID
WOS:001138951400006
DOI
URL
URL Institutional Repository
Abstract
<jats:p>BACKGROUND: Adjuvant bacillus Calmette-Guérin (BCG) is recommended for high-risk (HR) non-muscle invasive bladder cancer (NMIBC), but BCG shortages have led to exploration of reduced-dose regimens and shortened maintenance durations out of necessity, with limited data on treatment efficacy in Latin America. OBJECTIVE: Oncological outcomes of HR-NMIBC patients treated with reduced (RD,1/4th dose) vs full dose (FD) BCG instillations of Danish Strain 1331 BCG. METHODS: We performed a retrospective study of HR-NMIBC patients treated with BCG between 2003 and 2022 at our center in Santiago Chile. We stratified patients according to either RD (1/4th dose) or FD BCG. Univariate and multivariable Cox regression models were used to predict recurrence. Kaplan-Meier method was used to calculate survival estimates. RESULTS: Of a total of 200 patients, 116 (58%) had RD and 84 (42%) FD BCG. Median follow-up was 57 months (IQR: 29–100). Patients who received FD BCG had a lower risk of recurrence (HR: 0.41, 95% CI 0.22–0.74) and high-grade (HG)-recurrence (HR: 0.30, 95% CI 0.15–0.61; p = 0.001). More patients in the RD vs FD group progressed to MIBC (10/84 vs 2/116; p = 0.18). Additionally, patients were less likely to stop BCG treatment in the RD group compared to the FD group due to toxicity (5% vs 11%, p = 0.14). CONCLUSIONS: A 1/4th dose of Danish Strain 1331 BCG treatment was associated with worse recurrence free rate and HG-recurrence rate in our cohort. Patients with RD had lower discontinuation treatment rates due to a reduced toxicity profile. These findings would suggest that RD BCG would compromise oncological outcomes in HR-NMIBC patients.</jats:p>
Cite this document
Grajales, V., Contieri, R., Tan, W. S., Flores, M., Schultz, M., Pinochet, R., Bustamante, A., Kamat, A. M., & Fernández, M. I. (2023). Comparative analysis of very reduced vs full dose bcg treatment for high-risk non-muscle invasive bladder cancer: A contemporary experience from chile. Bladder Cancer, 9(4), 327-334. https://doi.org/10.3233/BLC-230047
Subjects
bacillus calmette-guerin

; 

bcg. non-muscle-invasive bladder cancer

; 

reduced dose

; 

bcg vaccine

; 

adult

; 

aged

; 

article

; 

bcg vaccination

; 

chile

; 

cohort analysis

; 

confidence interval

; 

female

; 

follow up

; 

hazard ratio

; 

high risk patient

; 

human

; 

kaplan meier method

; 

major clinical study

; 

male

; 

multivariate analysis

; 

non muscle invasive bladder cancer

; 

proportional hazards model

; 

recurrence risk

; 

retrospective study

; 

special situation for pharmacovigilance

; 

univariate analysis