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J Urol. 2008 Apr;179(4):1307-11; discussion 1311-2. doi: 10.1016/j.juro.2007.11.045. Epub 2008 Mar 4.

The effect of intravesical instillation of antifibrinolytic agents on bacillus Calmette-Guerin treatment of superficial bladder cancer: a pilot study.

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  • 1Department of Urology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Abstract

PURPOSE:

We determined whether intravesical instillation of antifibrinolytic agents could improve the antitumor effect of bacillus Calmette-Guerin. We also investigated the impact of these antifibrinolytic agents on the dose of bacillus Calmette-Guerin required for a therapeutic effect.

MATERIALS AND METHODS:

In this randomized, prospective, double-blind, controlled pilot study 257 patients with superficial bladder cancer were randomized into groups A through E. They received 100 to 120 mg intravesical bacillus Calmette-Guerin plus 100 mg para-aminomethylbenzoic acid, 50 to 60 mg bacillus Calmette-Guerin plus 100 mg para-aminomethylbenzoic acid, 100 to 120 mg bacillus Calmette-Guerin plus 2.0 gm epsilon aminocaproic acid, 50 to 60 mg bacillus Calmette-Guerin plus 2.0 gm epsilon aminocaproic acid and 100 to 120 mg bacillus Calmette-Guerin alone, respectively. Prothrombin time and activated partial thromboplastin time of each patient were determined at 2 hours after instillation, and adverse events were evaluated. Tumor recurrence was assessed every 3 months postoperatively by cystoscopy. Median followup was 26.0, 25.0, 24.5, 25.0 and 25.5 months, respectively.

RESULTS:

No significant change in prothrombin time or activated partial thromboplastin time was observed, and analysis showed no significant difference in prothrombin time or activated partial thromboplastin time among groups A through E (p = 0.693, 0.756). Recurrence rates at a minimum of median 2 years were 10.6%, 11.1%, 10.0%, 9.3% and 31.8% in groups A through E, respectively. The log rank test showed that recurrence-free probability was statistically different comparing groups A, B, C and D with group E, respectively (p = 0.023, 0.037, 0.031 and 0.020), while pairwise comparisons among groups A, B, C and D showed no significant differences (each p >0.05). The rate of serious adverse events in groups A through E was 9.6%, 3.9%, 15.7%, 5.9% and 13.5%, respectively. However, the differences were not significant (p = 0.222).

CONCLUSIONS:

Intravesical instillation of para-aminomethylbenzoic acid or epsilon aminocaproic acid is a more effective and safer method to improve the bacillus Calmette-Guerin antitumor effect, and can reduce the dose of bacillus Calmette-Guerin with the same effect as the full dose.

PMID:
18289576
[PubMed - indexed for MEDLINE]
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