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Efficacy and Safety of Low-Dose BCG vs Standard-Dose BCG in NMIBC

Ref: Choi S. etal., Low-dose versus standard-dose bacille Calmette–Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials, Investig Clin Urol. 2022 Mar;63(2):140-150. Doi: 10.4111/icu.20210340.

Introduction

Several studies have been conducted to evaluate reducing the recurrence and progression of non-muscle-invasive bladder cancer (NMIBC). Intravesical Bacille Calmette-Guérin (BCG) instillation has demonstrated greater efficacy in these patients than the chemotherapeutic agents. However, adverse effects (AEs) have been a major cause of concern resulting in therapy withdrawal. There has been a worldwide shortage of BCG and a low-dose BCG might be a better option.

Aim

This meta-analysis evaluated whether low-dose BCG could maintain efficacy and reduce AEs in patients with NMIBC.

Method

Study Design

  • Systematic review and meta-analysis of randomized controlled trials (RCTs).

Treatment Strategy

  • The eligible RCTs were identified after an extensive literature search of PubMed, Embase, the Cochrane Library, CINAHL, Web of Science, and Scopus databases.
  • A total of 9 RCTs (n=1217) were included and the odds ratios (ORs) with 95% confidence intervals (CIs) for the low and standard doses were compared.
  • A low dose was defined as a low volume of BCG compared with the standard BCG dose (Armand Frappier, 120 mg; Connaught, 81 mg; Danish 1331, 120 mg; modified Danish 1331, 120 mg; Tokyo 172, 80 mg).

Endpoints

  • Rate of recurrence
  • Tumor progression
  • Cancer-specific survival (CSS) rate
  • Overall survival (OS) rate
  • AEs
  • Treatment withdrawal rate

Results

  • The recurrence rate was higher in the low-dose group,
  • However, tumor progression, CSS and OS was similar among the groups as seen in Figure 1.

Figure 1. Comparison of endpoints

  • The incidence of AEs was lower in the low-dose group (OR, 0.41; 95% CI, 0.28-0.62; p<0.0001).
  • The treatment withdrawal rate was also significantly less in the low-dose group as seen in Figure 1.

Conclusion

  • Although low-dose BCG had higher recurrence rate than standard-dose BCG, tumor progression, cancer-specific survival, and overall survival were similar between the doses.
  • The safety profile of low-dose BCG was better than the standard-dose as demonstrated by lesser incidence of adverse effects and lower withdrawal rate.
  • Low-dose BCG may be a feasible alternative in the current scenario of BCG shortage.

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