1346 SIGLE PREOPERATIVE INTRAVESICAL INSTILLATION OF ELECTROMOTIVE MITOMYCIN-C FOR PRIMARY NON-MUSCLE INVASIVE BLADDER CANCER: A RANDOMIZED TRIAL

Article Outline

• INTRODUCTION AND OBJECTIVES
• METHODS
• RESULTS
• CONCLUSIONS
• Copyright

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INTRODUCTION AND OBJECTIVES 

We compared the effects of one immediate pre-transurethal resection (TUR) intravesical electromotive (EMDA) mitomycin-C (MMC) instillation with one early post-TUR intravesical passive diffusion (PD) MMC instillation and TUR alone in patients with non-muscle invasive bladder cancer (NMIBC).

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METHODS 

From 1994 to 2003, 352 elegible patients with primary NMIBC were randomized into 3 groups who underwent transurethral resection alone (TUR/alone group; n=116); TUR plus single immediate postoperative instillation (immediately after TUR) of 40 mg PD/MMC with a dwell time of 60 minutes (PD/MMC post-TUR group; n=119); or single immediate preoperative instillation (immediately before TUR) of 40 mg EMDA/MMC with 20 mA electric current for 30 minutes (EMDA/MMC pre-TUR group; n=117). Patients with intermediate and high risk NMIBC underwent adjuvant intravesical therapy. The primary end points were the recurrence rate and disease-free interval. All clinical analyses were performed on an intent to treat basis.

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RESULTS 

During a median followup of 85.4 months there was recurrence in 188/352 patients (53.4%), including 74/116 (63.8%) TUR/alone group, 70/119 (58.8%) in PD/MMC post-TUR group and 44/117 (37.6%) in EMDA/MMC pre-TUR group (p=<0.001). In 30/352 patients (8.5%) with low risk disease, only 1 (3.3%), in EMDA/MMC pre-TUR group, had recurrence (p=0.409). In 225/352 patients (63.9%) with intermediate risk disease, 119 (52.9%) had recurrence, 47/75 (62.7%) in TUR/alone group, 46/77 (59.7%) in PD/MMC post-TUR group and 26/73 (35.6%) in EMDA/MMC pre-TUR group (p=0.001). In 97/352 patients (27.6%) with high disease, 68 (70.1%) had recurrence, 27/33 (84.4%) in TUR/alone group, 24/32 (75.0%) in PD/MMC post-TUR group and 17/33 (51.5%) in EMDA/MMC pre-TUR group (p=0.012). Overall median disease-free interval was 12.9 months for TUR/alone group, 16.4 months for PD/MMC post-TUR group and 56.9 for EMDA/MMC pre-TUR group (p=<0.001). In the PD/MMC post-TUR group 43 patients (36.1%) had bladder symptoms and 28 (23.5%) had treatment discontinued because of pain or bladder spasms. No side effects were reported in the EMDA/MMC pre-TUR group.

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CONCLUSIONS 

In patients with intermediate and high risk NMIBC one immediate pre-TUR intravesical EMDA/MMC instillation decreases the risk of recurrence and enhances the disease-free interval, compared with one immediate post-TUR intravesical PD/MMC instillation and TUR alone.

Robert Stephen leaves us with the memory of an inspiring teacher, scientist, colleague and friend. We sorely miss him.