Intravesical Bacillus Calmette-Guérin versus epirubicin for Ta and T1 bladder cancer

Transurethral resection (TUR) is the usual treatment method for patients who, when examined with a cystoscope, are found to have abnormal growths on the urothelium (stage Ta) and/or in the lamina propria (stage T1). However post-operation tumour recurrence is a major clinical problem. Intravesical Bacillus Calmette-Guérin or epirubicin following surgery are therefore often used to try to prevent the cancer recurrence. This review found that intravesical Bacillus Calmette-Guérin is more efficacious than epirubicin to prevent cancer recurrence. However, Bacillus Calmette-Guérin appears to induce greater local and systemic adverse effects than epirubicin.

Authors' conclusions: 

The data from the present meta-analysis indicate that intravesical BCG treatment is more efficacious than EPI in reducing tumour recurrence for Ta and T1 bladder cancer. However, BCG appears to be associated with a higher incidence of adverse effects, such as drug-induced cystitis, haematuria and systemic toxicity, than EPI. The overall quality of the evidence is rather low. Well-designed, high quality randomised controlled trials with good allocation concealment are required.

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Background: 

Bladder cancer accounts for approximately 4.4% of adult malignancies, and approximately 80% of bladder cancer presents initially as transitional cell carcinoma that is confined to the urothelium (stage Ta) or lamina propria (stage T1). Intravesical administration of Bacillus Calmette-Guérin (BCG) and epirubicin (EPI) has been proven to reduce tumour recurrence and prevent or delay progression to muscle invasion and metastases. However, comparison of the effectiveness and safety of intravesical BCG and EPI in bladder cancer has yet to be explored.

Objectives: 

To compare the effectiveness and safety of BCG with EPI in the treatment of Ta and T1 bladder cancer.

Search strategy: 

A comprehensive search of MEDLINE (January 1966 to April 2010), EMBASE (January 1980 to April 2010), the Cochrane Library(Issue 5, 2010), Health Services Technology, Administration, and Research (HealthSTAR), and CancerLit etc, was performed, and handsearching of relevant journals was undertaken.

Selection criteria: 

All randomised or quasi-randomised trials (in which allocation was obtained by alternation - e.g. alternate medical records, date of birth, or other predictable methods) in patients with Ta or T1 bladder cancer that compared intravesical BCG with EPI were included. No language restrictions were applied.

Data collection and analysis: 

Trial eligibility, methodological quality and data extraction were assessed independently by two reviewers. We compared dichotomous outcomes (frequency of tumour recurrence, progressive disease by stage, mortality, distant metastases, local and systemic adverse effects, treatment delayed or stopped due to adverse effects) using risk ratios (RR) with 95% confidence intervals (CI).

Main results: 

Five trials of 1,111 participants were included in this review. 549 patients were treated with BCG and 562 with EPI. Baseline characteristics of included participants were similar amongst the five trials. We found that nearly none of the included studies described clearly the method of sequence generation, allocation concealment and blinding. Only two trials of 769 patients had sufficient data for us to analyze both disease-specific and overall mortality. There was no significant difference for mortality between BCG and EPI (overall mortality: RR 0.86, 95% CI 0.71 to 1.04, P = 0.12; disease-specific mortality: RR 0.94, 95% CI 0.23 to 0.80, P = 0.93). In four studies reporting local adverse effects, BCG was associated with significantly more drug-induced cystitis (BCG, 54.1% (232/429); EPI, 31.7% (140/441)) and haematuria (BCG, 30.8% (132/429); EPI, 16.1% (71/440)). Similarly, in three studies reporting systemic adverse effects, BCG had significantly higher toxicity than the EPI (34.8% (134/385) versus 1.3% (5/393), respectively).

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