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卡介苗诱导治疗非肌层浸润性膀胱癌的耐受性和疗效

Tolerability and efficacy of induction Bacillus Calmette-Guérin for non-muscle invasive bladder cancer.

作者信息

Patel Mann, Rajagopalan Aravind, Cahill Ellen M, Chua Kevin J, Passarelli Rachel, Pfail John, Doppalapudi Sai Krishnaraya, Golombos David, Jang Thomas, Packiam Vignesh T, Ghodoussipour Saum

机构信息

Division of Urology, Department of Surgery, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey 08901, United States.

Department of Urology, School of Medicine, Yale University, New Haven, Connecticut 06510, United States.

出版信息

Bladder (San Franc). 2025 Apr 11;12(2):e21200031. doi: 10.14440/bladder.2024.0051. eCollection 2025.

Abstract

BACKGROUND

Intravesical Bacillus Calmette-Guérin (BCG) is the standard treatment for intermediate-risk, high-grade, and high-risk non-muscle invasive bladder cancer (NMIBC). However, it is associated with adverse effects, potentially causing treatment interruptions or discontinuation.

OBJECTIVES

This study analyzed the tolerability and efficacy of induction BCG, with associated patient- and disease-related factors.

METHODS

A retrospective analysis was conducted on BCG-naive patients diagnosed with high-grade NMIBC, who received induction BCG at our institution between 2011 and 2021. Tolerability was defined as the completion of a 6-week induction course of BCG without treatment interruption or discontinuation. Multivariable logistic regression was performed to determine risk factors associated with the inability to tolerate treatment.

RESULTS

Induction BCG was given to 203 NMIBC patients, where 147 (72%) patients tolerated the treatment. Treatment interruptions occurred in 44 (22%) patients, while 12 (5.9%) patients discontinued the treatment. The median length of interruption was 1 week, primarily due to concerns about urinary tract infection (UTI) ( = 18, 41%) or gross hematuria ( = 5, 11%). No significant difference in 1-year recurrence rates was observed between those who tolerated BCG and those who did not (50% vs. 48%). Risk factors associated with the inability to tolerate induction BCG included male sex (odds ratio [OR] = 5.76, < 0.01), hypertension (OR = 3.47, = 0.02), and low pre-treatment hemoglobin levels (OR = 0.73, = 0.03).

CONCLUSION

Inability to tolerate BCG occurred in 28% of patients, with 5.9% experiencing discontinuation. Interruptions were short, mostly concerning UTI, and rarely leading to discontinuation. Poor tolerability was associated with male sex, hypertension, and low pre-treatment hemoglobin levels, highlighting critical targets for reducing the risk of BCG interruption or discontinuation.

摘要

背景

膀胱内灌注卡介苗(BCG)是中危、高危和高级别非肌层浸润性膀胱癌(NMIBC)的标准治疗方法。然而,它会带来不良反应,可能导致治疗中断或停止。

目的

本研究分析了诱导性BCG的耐受性和疗效,以及相关的患者和疾病相关因素。

方法

对2011年至2021年期间在我院接受诱导性BCG治疗的初治高级别NMIBC患者进行回顾性分析。耐受性定义为完成6周的BCG诱导疗程且未中断或停止治疗。进行多变量逻辑回归以确定与无法耐受治疗相关的危险因素。

结果

203例NMIBC患者接受了诱导性BCG治疗,其中147例(72%)患者耐受治疗。44例(22%)患者出现治疗中断,12例(5.9%)患者停止治疗。中断的中位时长为1周,主要原因是担心尿路感染(UTI)(n = 18,41%)或肉眼血尿(n = 5,11%)。耐受BCG和未耐受BCG的患者1年复发率无显著差异(50%对48%)。与无法耐受诱导性BCG相关的危险因素包括男性(比值比[OR]=5.76,P<0.01)、高血压(OR = 3.47,P = 0.02)和治疗前血红蛋白水平低(OR = 0.73,P = 0.03)。

结论

28%的患者无法耐受BCG,5.9%的患者停止治疗。中断时间较短,主要与UTI有关,很少导致停止治疗。耐受性差与男性、高血压和治疗前血红蛋白水平低有关,突出了降低BCG中断或停止风险的关键靶点。

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