Di Stasi Savino M, Giannantoni Antonella, Stephen Robert L, Capelli Giovanni, Navarra Pierluigi, Massoud Renato, Vespasiani Giuseppe
Departments of Urology and Clinical Biochemistry, Tor Vergata University, Via Torrice n. 4, 00189 Rome, Italy.
J Urol. 2003 Sep;170(3):777-82. doi: 10.1097/01.ju.0000080568.91703.18.
In laboratory studies electromotive mitomycin C (MMC) demonstrated markedly increased transport rates compared with passive transport. We performed a prospective study in patients with high risk superficial bladder cancer to assess the efficacy of intravesical electromotive vs passive MMC using bacillus Calmette-Guerin (BCG) as a comparative treatment.
Following transurethral resection and multiple biopsies 108 patients with multifocal Tis, including 98 with T1 tumors, were randomized into 3 equal groups of 36 each who underwent 40 mg electromotive MMC instillation with 20 mA electric current for 30 minutes, 40 mg passive MMC with a dwell time of 60 minutes or 81 mg BCG with a dwell time of 120 minutes. Patients were scheduled for an initial 6 weekly treatments, a further 6 weekly treatments for nonresponders and a followup 10 monthly treatments for responders. Primary end points were the complete response rate at 3 and 6 months. MMC pharmacokinetics were assessed.
The complete response for electromotive vs passive MMC at 3 and 6 months was 53% versus 28% (p = 0.036) and 58% versus 31% (p = 0.012). For BCG the responses were 56% and 64%. Median time to recurrence was 35 vs 19.5 months (p = 0.013) and for BCG it was 26 months. Peak plasma MMC was significantly higher following electromotive MMC than after MMC (43 vs 8 ng/ml), consistent with bladder content absorption.
Intravesical electromotive administration increases bladder uptake of MMC, resulting in an improved response rate in cases of high risk superficial bladder cancer.
在实验室研究中，与被动转运相比，电动丝裂霉素C（MMC）显示出明显更高的转运速率。我们对高危浅表性膀胱癌患者进行了一项前瞻性研究，以评估膀胱内电动MMC与被动MMC的疗效，并将卡介苗（BCG）作为对照治疗。
经尿道切除及多次活检后，108例多灶性Tis患者（包括98例T1肿瘤患者）被随机分为3组，每组36例，分别接受40mg电动MMC（20mA电流，持续30分钟）、40mg被动MMC（保留时间60分钟）或81mg BCG（保留时间120分钟）膀胱灌注。患者计划接受最初6次每周治疗，无反应者再接受6次每周治疗，反应者随后接受10次每月随访治疗。主要终点为3个月和6个月时的完全缓解率。评估了MMC的药代动力学。
电动MMC与被动MMC在3个月和6个月时的完全缓解率分别为53%对28%（p = 0.036）和58%对31%（p = 0.012）。BCG的缓解率分别为56%和64%。复发的中位时间为35个月对19.5个月（p = 0.013），BCG为26个月。电动MMC后血浆MMC峰值显著高于被动MMC后（43对8ng/ml），这与膀胱内容物吸收一致。
膀胱内电动给药可增加MMC在膀胱中的摄取，从而提高高危浅表性膀胱癌患者的缓解率。
