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接受卡介苗、丝裂霉素或化疗热疗辅助治疗的非肌肉浸润性膀胱癌患者的生活质量和不良反应。

Quality of life and adverse events in patients with nonmuscle invasive bladder cancer receiving adjuvant treatment with BCG, MMC, or chemohyperthermia.

机构信息

Department of Urology, University Hospital 12 de Octubre, Madrid, Spain.

Department of Urology, University Hospital 12 de Octubre, Madrid, Spain.

出版信息

Urol Oncol. 2021 Jan;39(1):76.e9-76.e14. doi: 10.1016/j.urolonc.2020.07.003. Epub 2020 Aug 1.

Abstract

INTRODUCTION

Chemohyperthermia (CHT) with mitomycin C (MMC) is together with Bacillus Calmette-Guérin (BCG), and passive MMC, a treatment option for patients with non muscle-invasive bladder cancer. There are no data published about the impact of CHT in quality of life (QoL). We evaluated QoL and adverse events (AE) in this 3-arm observational study.

PATIENTS AND METHODS

Prospective observational study from September 2016 to March 2017, we recruited consecutive patients that received adjuvant treatment after transurethral resection of bladder tumor. Patients received induction courses of either BCG, CHT, or passive MMC. Patients filled the questionnaires Functional assessment of cancer therapy for bladder cancer patients (FACT-Bl) and International prostate symptom score (IPSS) before, during, and after the induction course. A urologist documented AE using Common Terminology Criteria for AE (CTCAE criteria).

RESULTS

A total of 56 patients, receiving a total of 296 bladder instillations (BCG n = 27, CHT n = 14 and MMC n = 15). FACT-Bl showed statistically significant differences in the fourth week in favor of CHT versus BCG, IPSS did not show statistically significant differences before, during, and after induction course in all 3 arms. All patients recovered their baseline QoL at the end of the induction treatment. Overall 55.5%, 50% and 20% of patients presented any grade of AE in the BCG, CHT and MMC groups respectively. About 7% of patients in BCG and CHT arms had to discontinue treatment due to AE. BCG and CHT showed a similar rate of AE but in CHT were mostly grade I and BCG had grade I, II, and IV. Passive MMC had the safest profile.

CONCLUSION

There are no clinically significant differences between BCG, CHT, and passive MMC regarding QoL and lower urinary tract symptoms during the induction course. CHT has a more favorable AE profile when compared with BCG.

摘要

介绍

丝裂霉素 C(MMC)联合化疗热疗(CHT)与卡介苗(BCG)和被动 MMC 一样,是治疗非肌层浸润性膀胱癌患者的选择之一。目前尚无关于 CHT 对生活质量(QoL)影响的数据发表。我们在这项 3 臂观察性研究中评估了 QoL 和不良事件(AE)。

患者和方法

2016 年 9 月至 2017 年 3 月,我们连续招募了接受经尿道膀胱肿瘤切除术辅助治疗的患者。患者接受 BCG、CHT 或被动 MMC 诱导治疗。患者在诱导治疗前后填写膀胱癌患者癌症治疗功能评估问卷(FACT-Bl)和国际前列腺症状评分(IPSS)。泌尿科医生使用常见不良事件术语标准(CTCAE 标准)记录 AE。

结果

共 56 例患者,共进行了 296 次膀胱灌注(BCG n=27,CHT n=14,MMC n=15)。FACT-Bl 在第四周显示出 CHT 与 BCG 相比具有统计学显著差异,而在诱导治疗前后,3 组的 IPSS 均无统计学显著差异。所有患者在诱导治疗结束时均恢复了基线 QoL。BCG、CHT 和 MMC 组的患者分别有 55.5%、50%和 20%出现任何级别的 AE。BCG 和 CHT 组各有 7%的患者因 AE 而停止治疗。BCG 和 CHT 的 AE 发生率相似,但 CHT 主要为 1 级,而 BCG 为 1、2 和 4 级。被动 MMC 的安全性最高。

结论

在诱导治疗期间,BCG、CHT 和被动 MMC 在 QoL 和下尿路症状方面没有临床显著差异。与 BCG 相比,CHT 的 AE 谱更有利。

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