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. 2023 Sep 25;9(3):227-236.
doi: 10.3233/BLC-230044. eCollection 2023.

The Impact of Dose Reduction of Bacillus Calmette-Guerin on Oncological Outcomes and Toxicity in Non-Muscle Invasive Bladder Cancer: A Systematic Review and Meta-Analysis

Wadi Azuri  1   2 , Jorge Horacio Jaunarena  1   3 , Juan Jorge Camean  1 , Joaquín Chemi  1   4 , Alberto Villaronga  1 , Siamak Daneshmand  5 , Gustavo Martín Villoldo  1
Affiliations

The Impact of Dose Reduction of Bacillus Calmette-Guerin on Oncological Outcomes and Toxicity in Non-Muscle Invasive Bladder Cancer: A Systematic Review and Meta-Analysis

Wadi Azuri et al. Bladder Cancer. .

Abstract

Background: Bacillus Calmette-Guerin (BCG) is the standard adjuvant treatment for intermediate and high-risk non-muscle invasive bladder cancer (NMIBC) following transurethral resection of the bladder (TURB). However, the optimal dose, strain, and schedule of BCG remain unclear.

Objective: To evaluate the impact of BCG dose reduction on oncological outcomes and toxicity in patients with non-muscle invasive bladder cancer.

Methods: We performed a systematic review of the literature in PubMed, EMBASE, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases. Selected studies were analyzed for Meta Analysis using PRISMA criteria. The study focused on disease recurrence, progression, and toxicity. We also compared the oncological outcomes of the different BCG strains.

Results: A total of 2963 patients in 13 randomized controlled trials were included. In recurrence analysis, we found a non-significant difference between the full dose and any dose reduction of BCG (RR = 1.17, [1.06-1.28], I2 = 0%, p = 0.7). In terms of progression, the difference was also non-statistically significant (RR: 1.12 [0.89 - 1.41], I2 = 0%, p = 0.93). In the toxicity analysis, there were more local (RR: 0.81 [0.67-0.99] I2 = 76%; p < 0.01) and systemic (RR: 0.53 [0.34-0.82] I2 = 83%; p < 0.01) side effects in the full dose group than in the dose reduction group. There were no statistically significant differences in oncological outcomes between the analyzed BCG strains.

Conclusions: Dose reduction did not affect the oncological outcomes of patients with NMIBC who received adjuvant therapy with BCG. On the other hand, dose reduction showed a significant trend towards fewer systemic and local side effects. Further studies comparing oncological and toxicity outcomes using different strains are needed.

Keywords: BCG; Bladder cancer; NMIBC; progression; recurrence; toxicity.

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Conflict of interest statement

Dr. Azuri has no conflicts of interest to report. Dr. Jaunarena has no conflicts of interest to report. Dr. Camean has no conflicts of interest to report. Dr. Chemi has no conflicts of interest to report. Dr. Villaronga has no conflicts of interest to report. Dr. Daneshmand 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. Apart from that, has no conflicts of interest to report. Dr. Villoldo has no conflicts of interest to report.

Figures

Fig. 1
Fig. 1
Study selection flow.
Fig. 2
Fig. 2
Funnel plot showing heterogeneity between included studies.
Fig. 3
Fig. 3
Disease recurrence.
Fig. 4
Fig. 4
Disease progression.
Fig. 5
Fig. 5
Systemic toxicity.
Fig. 6
Fig. 6
Local toxicity.
See this image and copyright information in PMC

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