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Low-dose versus standard-dose bacille Calmette-Guerin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials.

ABSTRACT:

Purpose

Intravesical BCG (bacille Calmette-Guérin) instillation in patients with non-muscle-invasive bladder cancer decreases the risk for tumor recurrence and progression. After one BCG product was discontinued, a chronic global BCG shortage occurred. We focused on identifying a reduced dose of BCG that could maintain efficacy and reduce adverse effects.

Materials and methods

We conducted a comprehensive literature search of PubMed, Embase, the Cochrane Library, CINAHL, Web of Science, and Scopus to identify randomized controlled trials through April 2021. The odds ratios (ORs) and 95% confidence intervals (CIs) for the low and standard doses in nine studies 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).

Results

The low-dose group experienced aggravated recurrence (OR, 1.45; 95% CI, 1.09-1.94; p=0.01) but similar progression (OR, 1.11; 95% CI, 0.76-1.62; p=0.59), similar cancer-specific survival (OR, 1.02; 95% CI, 0.60-1.75; p=0.93), similar overall survival (OR, 1.09; 95% CI, 0.76-1.56; p=0.65), favorable adverse effects (OR, 0.41; 95% CI, 0.28-0.62; p<0.0001), and favorable withdrawal (OR, 0.42; 95% CI, 0.25-0.71; p=0.001).

Conclusions

Low-dose BCG had more unfavorable outcomes than did standard-dose BCG in terms of recurrence. Tumor progression, cancer-specific survival, and overall survival were similar between the doses. Low-dose BCG improved adverse effects and withdrawal. In the setting of BCG shortage, low-dose BCG may have strong potential as an alternative.

SUBMITTER: Choi SY

PROVIDER: S-EPMC8902423 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Low-dose versus standard-dose bacille Calmette-Guérin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials.

Choi Se Young SY Ha Moon Soo MS Kim Jung Hoon JH Chi Byung Hoon BH Kim Jin Wook JW Chang In Ho IH Kim Tae-Hyoung TH Myung Soon Chul SC

Investigative and clinical urology 20220301 2

<h4>Purpose</h4>Intravesical BCG (bacille Calmette-Guérin) instillation in patients with non-muscle-invasive bladder cancer decreases the risk for tumor recurrence and progression. After one BCG product was discontinued, a chronic global BCG shortage occurred. We focused on identifying a reduced dose of BCG that could maintain efficacy and reduce adverse effects.<h4>Materials and methods</h4>We conducted a comprehensive literature search of PubMed, Embase, the Cochrane Library, CINAHL, Web of Sc ...[more]

PMID: 35244987

Similar Datasets

Project description:Whether low-dose Bacillus Calmette-Guerin (BCG) treatment can reduce the side effects while maintaining efficacy for patients with nonmuscle invasive bladder cancer (NMIBC) is controversial.To investigate whether low-dose BCG treatment can reduce the side effects while maintaining efficacy for patients with NMIBC when compared with standard-dose BCG treatment.A comprehensive literature search of PubMed, EMBASE, CINAHL, LILACS, and CENTRAL databases was conducted to identify relevant randomized controlled trials (RCT) or quasi-randomized controlled trials (qRCT) that have assessed the efficacy of low- and standard-dose BCG therapy for patients with NMIBC. Systematic review and meta-analysis were performed according to Preferred Reporting Items for Systematic Reviews and Meta-analysis Criteria.Six RCTs and 2 qRCTs were eligible for meta-analysis. Low-dose BCG instillation was not inferior to reduce the risk of bladder tumor recurrence (hazard ratio [HR], 1.15; 95% confidence interval [CI], 1.00-1.31; P = 0.05), meanwhile no difference was found regarding tumor progression (HR = 1.08; 95%CI, 0.83-1.42; P = 0.57). However, low-dose BCG provided a significantly lower incidence of overall side effects (RR = 0.75; 95%CI, 0.60-0.94; P = 0.01), systemic side effects (RR = 0.57; 95%CI, 0.34-0.97; P = 0.04), severe side effects (RR = 0.52; 95%CI, 0.36-0.74; P = 0.0003), and withdrawal due to BCG toxicity (RR = 0.49; 95%CI, 0.26-0.91; P = 0.02). In contrast, local side effects were comparable between low- and standard-dose arms (RR = 0.89; 95%CI, 0.73-1.08; P = 0.24).Low-dose BCG instillation significantly reduces the incidence of overall side effects, especially severe and systemic symptoms in patients with NMIBC, while the oncological control efficacy of low-dose BCG is not inferior to standard-dose BCG. Further studies with stratification using different risk factors at randomization are required to assess whether the efficacy of low-dose BCG is comparable to standard dose BCG for different risk of patients.PROSPERO registration No CRD42014014871 (http://www.crd.york.ac.uk/prospero/).