Electromotive Drug Administration Chemotherapy with Mitomycin C Versus Bacillus Calmette-Guerin for the Treatment of Non-Muscle Invasive Bladder Cancer.

IF 1 4区医学 Q4 ONCOLOGY

Bladder Cancer Pub Date : 2023-06-27 eCollection Date: 2023-01-01 DOI:10.3233/BLC-230042

María Teresa Melgarejo Segura, Ana Morales Martínez, Yaiza Yáñez Castillo, Miguel Ángel Arrabal Polo, Francisco Gutiérrez Tejero, Manuel Pareja Vílchez, Miguel Arrabal Martín

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引用次数: 0

Abstract

Background: Devices that increase the penetrance of intravesical chemotherapeutics are emerging as alternatives to classical Bacillus Calmette Guérin (BCG) treatment.

Objective: To compare the efficacy of mitomycin C applied with the electromotive drug delivery device (MMC-EMDA) versus BCG in patients with intermediate and high-risk non-muscle-invasive bladder cancer (NMIBC) without carcinoma in situ (CIS).

Methods: Prospective non-randomized study in which 47 patients received MMC-EMDA (40 mg of MMC diluted in 50 mg of distilled water at 20 mA for 30 min. Regimen of 6 weekly and then 6 monthly instillations) and 48 patients received BCG (50 mg of OncoCITE® diluted in 50 ml of normal saline for 60 min. Regimen of 6 weekly instillations and then 3 weekly instillations at months 3, 6 and 12). The primary endpoint was the recurrence-free rate (RFR) at 24 months. Secondary endpoints were time to recurrence and progression-free rate (PFR) at 24 months follow-up.

Results: Baseline patient assessment and mean follow-up time were similar in both groups (MMC-EMDA group: 26.4 months; BCG group: 28.4 months (p = 0.44)). The RFR at 24 months was 80.9% for the MMC-EMDA group and 77.1% for the BCG group (p = 0.969). The mean time to recurrence was 12.5 months in the MMC-EMDA group and 14 months in the BCG group (p = 0.681). At 24 months, PFR was 97.9% in the MMC-EMDA group and 93.8% in the BCG group (p = 0.419).

Conclusions: No differences were found between MMC-EMDA and BCG treatments in patients with high-risk and intermediate-risk NMIBC without CIS.

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使用丝裂霉素 C 和卡介苗治疗非肌层浸润性膀胱癌的电动力给药化疗。

背景：可增加膀胱内化疗药物渗透性的装置正在成为传统卡介苗（BCG）治疗的替代品：比较使用电动给药装置（MMC-EMDA）的丝裂霉素 C 与卡介苗对无原位癌（CIS）的中高危非肌浸润性膀胱癌（NMIBC）患者的疗效：前瞻性非随机研究：47 名患者接受了 MMC-EMDA（40 毫克 MMC 稀释在 50 毫克蒸馏水中，电流为 20 毫安，持续 30 分钟。疗程为每周注射 6 次，然后每月注射 6 次），48 名患者接受卡介苗治疗（50 毫克 OncoCITE® 稀释在 50 毫升生理盐水中 60 分钟，疗程为每周注射 6 次，然后每月注射 6 次）。疗程为每周注射 6 次，然后在第 3、6 和 12 个月每周注射 3 次）。主要终点是 24 个月时的无复发率 (RFR)。次要终点是随访 24 个月时的无复发率（RFR）和无进展率（PFR）：两组患者的基线评估和平均随访时间相似（MMC-EMDA组：26.4个月；BCG组：28.4个月（P = 0.44））。24个月时，MMC-EMDA组的RFR为80.9%，BCG组为77.1%（p = 0.969）。MMC-EMDA组的平均复发时间为12.5个月，BCG组为14个月（p = 0.681）。24个月时，MMC-EMDA组的PFR为97.9%，BCG组为93.8%（p = 0.419）：结论：对于无 CIS 的高危和中危 NMIBC 患者，MMC-EMDA 和 BCG 治疗方法之间没有差异。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bladder Cancer Medicine-Urology

CiteScore

1.60

自引率

0.00%

发文量

期刊介绍： Bladder Cancer is an international multidisciplinary journal to facilitate progress in understanding the epidemiology/etiology, genetics, molecular correlates, pathogenesis, pharmacology, ethics, patient advocacy and survivorship, diagnosis and treatment of tumors of the bladder and upper urinary tract. The journal publishes research reports, reviews, short communications, and letters-to-the-editor. The journal is dedicated to providing an open forum for original research in basic science, translational research and clinical medicine that expedites our fundamental understanding and improves treatment of tumors of the bladder and upper urinary tract.