The effect of immediate neoadjuvant electromotive instillation of mitomycin C with Bacillus Calmette-Guérin versus BCG alone in non-muscle-invasive bladder cancer: A randomized controlled trial

丝裂霉素C联合卡介苗新辅助电动力灌注与单独使用卡介苗治疗非肌层浸润性膀胱癌的疗效比较:一项随机对照试验

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Abstract

PURPOSE: The clinical effect of neoadjuvant intravesical instillation of chemotherapy immediately before transurethral resection of bladder tumors (TURBT) has been a subject of recent research. The aim of this study was to assess the effect of immediate neoadjuvant electromotive instillation of mitomycin C before transurethral resection for patients with non-muscle-invasive urothelial bladder cancer. MATERIALS AND METHODS: Our study was a randomized clinical trial carried out on 50 patients diagnosed with non-muscle-invasive urothelial bladder cancer. Patients were classified into two groups: Group I consisted of 25 patients who received neoadjuvant electromotive drug administration of mitomycin C before TURBT and intravesical bacille Calmette-Guerin (BCG) per week for 6 weeks; Group II consisted of 25 patients who were treated with TURBT followed by intravesical BCG per week for 6 weeks alone (standard of care). Patients were followed up at 3, 6, 12, and 18 months by cystoscopy. RESULTS: Patients who received neoadjuvant electromotive drug administration of mitomycin C before TURBT in combination with BCG had a low recurrence rate compared with those who received BCG alone (12.0% vs. 48.0%, respectively; p=0.012) and a longer disease-free interval (88.0% vs. 52.0%, respectively; p=0.012). Four patients developed progression to muscle-invasive disease (16.0%) in the BCG alone group. However, this difference was not statistically significant (p=0.516). Regarding adverse effects, there were no statistically significant differences between the groups. CONCLUSIONS: Neoadjuvant intravesical electromotive drug administration of mitomycin C before TURBT is safe; reduces recurrence rates and enhances the disease-free interval compared with TURBT followed by BCG alone.

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