A Multicenter Study of 2-year Outcomes Following Hyperthermia Therapy with Mitomycin C in Treating Non-Muscle Invasive Bladder Cancer: HIVEC-E.

IF 1 4区医学 Q4 ONCOLOGY

Bladder Cancer Pub Date : 2022-12-14 eCollection Date: 2022-01-01 DOI:10.3233/BLC-220026

Wei Phin Tan, Ana Plata Bello, Carlos Garcia Alvarez, Félix Guerrero-Ramos, Daniel A González-Padilla, Cajetan Nzeh, Jose Manuel de la Morena, Ignacio Gonzalez Valcarcel de Torres, Kees Hendricksen, Francisco Javier Díaz Goizueta, Julio Fernandez Del Álamo, Francesco Chiancone, Paolo Fedelini, Massimiliano Poggio, Francesco Porpiglia, Victoria C Gonzalo Rodríguez, Javier Montero Torres, Daniel Wilby, Richard Robinson, Alejandro Sousa-Escandón, Juan León Mata, Jose L Pontones Moreno, Francisco Delgados Molina, Miguel A Adriazola Semino, Andrew T Stemberger, Jesús Calleja Escudero, Joan Palou Redorta, Wei Shen Tan

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引用次数: 0

Abstract

Introduction: High grade, non-muscle invasive bladder cancer (NMIBC) is usually treated with intravesical Bacillus Calmette-Guérin. Chemohyperthermia therapy (CHT) may be a novel alternative therapy for the treatment of NMIBC.

Objective: To evaluate the recurrence-free survival (RFS) of patients treated with CHT using the Combat bladder recirculation system (BRS) for NMIBC.

Methods: This was a prospective multi-institutional study of 1,028 consecutive patients with NMIBC undergoing CHT between 2012 and 2020. A total of 835 patients were treated with CHT with Mitomycin C (MMC). Disease was confirmed on transurethral resection of bladder tumor (TURBT) prior to starting CHT. Follow-up included cystoscopy and subsequent TURBT if recurrence/progression was suspected. The primary endpoint was RFS. Secondary endpoints were progression-free survival (PFS) and adverse events from CHT.

Results and limitations: Median follow up was 22.4 months (Interquartile range (IQR): 12.8 -35.8). Median age was 70.4 years (IQR: 62.1 -78.6). A total of 557 (66.7%), 172 (20.6) and 74 (8.9%) of patients were classified to BCG naïve, BCG unresponsive and BCG failure, respectively. The RFS at 12 months and 24 months for BCG naïve was 87.6% (95% CI 85.0% - 90.4%) and 75.0% (95% CI 71.3% - 78.8%), respectively. The RFS at 12 months and 24 months for BCG unresponsive cohort was 78.1% (95% CI 72.0% - 84.7%) and 57.4% (95% CI 49.7% - 66.3%), respectively. The RFS at 24 months for the BCG unresponsive cohort for CIS with/without papillary disease and papillary only disease were 43.6% (95% CI 31.4% -60.4%) and 64.5% (95% CI 55.4% - 75.1%), respectively. Minor adverse events occurred in 216 (25.6%) patients and severe events occurred in 17 (2.0%) patients.

Conclusions: CHT with MMC using the Combat BRS is effective in the medium term and has a favorable adverse event profile.

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丝裂霉素C热疗治疗非肌肉浸润性膀胱癌2年疗效的多中心研究:hiv - e

高级别、非肌肉浸润性膀胱癌(NMIBC)采用膀胱内卡介苗芽孢杆菌治疗。化疗热疗(CHT)可能是治疗NMIBC的一种新的替代疗法。目的:评价使用战斗膀胱再循环系统(BRS)治疗NMIBC的CHT患者的无复发生存率(RFS)。方法:这是一项前瞻性多机构研究，在2012年至2020年期间连续1028例NMIBC患者接受了CHT治疗。共有835例患者接受了CHT和丝裂霉素C (MMC)治疗。经尿道膀胱肿瘤切除术(TURBT)确诊。NMIBC患者行MMC合并CHT。随访包括膀胱镜检查，如果怀疑复发/进展，随后进行TURBT检查。主要终点为RFS。次要终点是无进展生存期(PFS)和CHT的不良事件。结果和局限性:中位随访时间为22.4个月(四分位间距(IQR): 12.8 -35.8)。中位年龄70.4岁(IQR: 62.1 -78.6)。557例(66.7%)、172例(20.6%)和74例(8.9%)患者被分为卡介苗naïve、卡介苗无应答和卡介苗难治性/复发性/不耐受。BCG naïve 12个月和24个月的RFS分别为87.6% (95% CI 85.0% - 90.4%)和75.0% (95% CI 71.3% - 78.8%)。BCG无应答组12个月和24个月的RFS分别为78.1% (95% CI 72.0% - 84.7%)和57.4% (95% CI 49.7% - 66.3%)。对于CIS阳性和CIS阴性患者，BCG无应答队列24个月时的RFS分别为43.6% (95% CI 31.4% - 60.4%)和64.5% (95% CI 55.4% - 75.1%)。发生轻微事件216例(25.6%)，发生严重事件17例(2.0%)。结论:使用Combat BRS的MMC合并CHT在中期是有效的，并且具有良好的不良事件特征。

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.