Elsevier

Urology

Volume 63, Issue 4, April 2004, Pages 682-686
Urology

Adult urology
Intravesical bacille calmette-guérin versus mitomycin c in superficial bladder cancer: formal meta-analysis of comparative studies on tumor progression

https://doi.org/10.1016/j.urology.2003.11.049Get rights and content

Abstract

Objectives

To compare the therapeutic efficacy of intravesical bacille Calmette-Guérin (BCG) with mitomycin C (MMC) on progression of Stage Ta and T1 bladder carcinoma.

Methods

Combined published and unpublished data from comparative studies on BCG versus MMC in superficial bladder carcinoma were analyzed, considering possible confounding factors. Odds ratios (ORs) and 95% confidence intervals (CIs) were used as the primary effect size estimate. Tumor progression was defined as progression to a higher tumor stage or the development of metastatic disease.

Results

In nine eligible clinical trials, 1277 patients were treated with BCG and 1133 with MMC. Within the overall median follow-up of 26 months, 7.67% of the patients in the BCG group and 9.44% of the patients in the MMC group developed tumor progression. In all nine individual studies and in the combined results, no statistically significant difference in the ORs for progression between the BCG and MMC-treated groups was found (combined OR = 0.77; 95% CI 0.57 to 1.03; P = 0.081). In the subgroup with BCG maintenance, the combined result of the five individual studies showed a statistically significant superiority of BCG over MMC (OR = 0.66; 95% CI 0.47 to 0.94; P = 0.02). In the four studies without BCG maintenance, the combined result indicated no statistically significant difference between the two treatments (OR = 1.16; 95% CI 0.65 to 2.07; P = 0.612). Potential confounders, such as tumor risk status, duration of follow-up, BCG strain, BCG and MMC treatment regimen, and year of publication did not significantly influence these results.

Conclusions

The results demonstrated statistically significant superiority for BCG compared with MMC for the prevention of tumor progression only if BCG maintenance therapy was provided.

Section snippets

Material and methods

For the methods of data extraction, statistical analysis, and reporting, the rules and principles of the Cochrane Collaboration Reviews7 and those published in a previous report3 on the relative effects of BCG and MMC against superficial bladder cancer recurrence were applied as far as was possible and feasible.

Results

In nine eligible clinical trials with a total of 2410 patients, the sample size range of the included trials was 91 to 418 patients. In total, 1277 patients were treated with BCG and compared with 1133 patients treated with MMC. Seven of these studies were prospective clinical trials and two were retrospective observational cohort studies with concurrent groups (Table I). The overall median follow-up was 26 months (mean 28.6 ± 16 SD, range 11.5 to 50.4). The mean follow-up duration was not

Comment

Published reports have a paucity of valid data on the effect of intravesical therapy on the progression of superficial bladder cancer4 probably because of the relatively small numbers of high-risk patients entered into clinical trials. Furthermore, many individual trials had low power to detect medically plausible differences between two treatment regimens, especially if both regimens were of valid efficacy. One way to overcome these problems is to perform a combined analysis of available

Conclusions

The evidence from this formal meta-analysis suggests that adjuvant intravesical BCG with maintenance treatment is effective and is superior to intravesical MMC chemotherapy for the prophylaxis of tumor progression in superficial bladder cancer. To patients with a risk of progression, adjuvant intravesical BCG therapy with maintenance should be offered as the treatment of choice.

References (23)

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This study was supported by an educational grant from Aventis Pasteur S. A., Lyon, France.

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