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Bacillus Calmette-Guerin Treatment Reduces Recurrence of Bladder Cancer Compared to Mitomycin C

Intravesical bacillus Calmette-Guerin (BCG) treatment appears to reduce the recurrence rate of bladder cancer compared to mitomycin C, but only in those patients at high risk of tumour recurrence, according to new research.

Intravesical BCG is significantly more effective than is transurethral resection alone in the prophylaxis of Ta and T1 bladder cancer, but the role of BCG compared with other intravesical agents is unclear.

Mike Shelley, MD, with the University Hospital of Wales, in Cardiff, United Kingdom, and colleagues conducted a systematic review and meta-analysis of the relative effectiveness of intravesical mitomycin C and BCG for tumour recurrence, disease progression and overall survival in patients with medium- to high-risk Ta and T1 bladder cancer.

The researchers searched major medical databases and relevant journals for randomised controlled trials, in any language and found 7 eligible articles, representing 1901 evaluable patients. Of the patients, 820 were randomised to mitomycin C and 1081 to BCG. Six trials had sufficient data for meta-analysis.

No significant difference was observed between mitomycin C and BCG for tumour recurrence in the six trials. However, significant heterogeneity was present between trials (P = 0.001).

A subgroup analysis of three trials including only high-risk Ta and T1 patients indicated no heterogeneity (P = 0.25). With mitomycin C used as the control in the meta-analysis, a negative ratio was in favour of BCG and was highly significant (P < 0.001).

The seventh trial used BCG in low doses for two arms of the trial (27 mg and 13.5 mg) compared with a standard dose of mitomycin C (30 mg), and recurrence rate was significantly lower for BCG (27 mg) than for mitomycin C (P = 0.001).

Two trials included sufficient data to analyse disease progression and survival, and disease progression (P = 0.16) and survival (P= 0.50) were similar.

Adverse effects included dysuria, cystitis, frequency and haematuria and were associated with both mitomycin C (30%) and BCG (44%). Systemic toxicity occurred with both agents (12% and 19%, respectively) although skin rash was more common with mitomycin C.

"It is unclear why intravesical BCG should be more effective than mitomycin C in high-risk patients. It may be that in high-risk tumors, the relatively reduced action of mitomycin C relates to poor drug absorption, as mitomycin C penetration depth is an important determinant of treatment effectiveness," Dr. Shelley and colleagues note.



Br J Urol 2004;93:485-490. "Intravesical bacillus Calmette-Guerin is superior to mitomycin C in reducing tumour recurrence in high-risk superficial bladder cancer: a meta-analysis of randomized trials"

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