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. 2023 Dec 13;9(4):327-334.
doi: 10.3233/BLC-230047. eCollection 2023.

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

Valentina Grajales  1 , Roberto Contieri  1 , Wei Shen Tan  1 , Marta Flores  2 , Marcela Schultz  3 , Rodrigo Pinochet  2 , Alberto Bustamante  2 , Ashish M Kamat  1 , Mario I Fernández  2
Affiliations

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

Valentina Grajales et al. Bladder Cancer. .

Abstract

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.

Keywords: BCG. non-muscle-invasive bladder cancer; Bacillus Calmette-Guerin; reduced dose.

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Conflict of interest statement

Valentina Grajales has no conflict of interest to report. Roberto Contieri has no conflict of interest to report. Wei Shen Tan was a consultant to Combat Medical. Marta Flores has no conflict of interest to report. Marcela Schultz has no conflict of interest to report. Rodrigo Pinochet has no conflict of interest to report. Alberto Bustamante has no conflict of interest to report. Ashish M. Kamat is an Editorial Board Member of this journal, but was not involved in the peer-review process nor had access to any information regarding its peer-review. Ashish M. Kamat is a consultant or advisory board member for Abbott Molecular, Arquer Diagnostics, ArTara Therapeutics, Asieris Pharmaceuticals, AstraZeneca, BioClin Therapeutics, Bristol Myers Squibb, Cepheid, Cold Genesys, Eisai, Engene, Ferring Pharmaceuticals, FerGene, Imagine Pharma, Janssen, MDxHealth, Medac, Merck, Pfizer, Photocure, ProTara Therapeutics, Roviant Sciences, Seattle Genetics, Sessen Bio, Theralase Technologies, TMC Innovation, and US Biotest; has received grants and/or research support from Adolor Corporation, Bristol Myers Squibb, FKD Industries, Heat Biologics, Merck, Photocure, SWOG/NIH, Specialized Programs of Research Excellence (SPORE), and AIBCCR; and holds the patent for Cytokine Predictors of Response to Intravesical Therapy (CyPRIT) jointly with UT MD Anderson Cancer Center. Mario I. Fernández is an Editorial Board Member of this journal, but was not involved in the peer-review process nor had access to any information regarding its peer-review. Mario I. Fernández is a consultant or advisory board member for Grünenthal.

Figures

Fig. 1
Fig. 1
Kaplan Meier curve stratified by BCG dose. A. recurrence free rate, p = 0.0007. B. HG-recurrence free rate, p = 0.0006.
Fig. 2
Fig. 2
Kaplan Meier curve for OS stratified by BCG dose, p = 0.10.
See this image and copyright information in PMC

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