经尿道非肌肉浸润性膀胱癌切除术后短时间持续盐水冲洗的随机研究。

IF 1.6 4区 医学 Q4 ONCOLOGY
Takehisa Onishi, Sho Sekito, Takuji Shibahara, Tadashi Yabana
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引用次数: 0

摘要

背景/目的:比较经尿道膀胱肿瘤切除术(TURBT)后短时间连续生理盐水膀胱冲洗(S-CSBI)与长时间生理盐水膀胱冲洗(L-CSBI)对非肌肉浸润性膀胱癌(NMIBC)的疗效和安全性。患者和方法:在2016年至2021年期间,纳入了323例基于膀胱镜外观的疑似原发性NMIBC患者。随机分配患者在TURBT后接受S-CSBI(3小时)或L-CSBI(过夜)。排除NMIBC和肌肉浸润性膀胱癌风险最高的患者。主要终点是S-CSBI的2年无复发生存率(RFS),并进行了非劣效性测试。2年RFS率(60%)差异15%被定义为比较长期CSBI的非劣效性裕度。结果:排除后,共有230例患者(S-CSBI组110例,L-CSBI组120例)保留用于按方案分析。S-CSBI和L-CSBI的2年RFS率分别为70.5%[95%可信区间(CI)=60.9-78.2]和70.5% (95%CI=61.4-77.9)。S-CSBI的95%CI高于60%的非劣效性下限,证实了S-CSBI对L-CSBI的非劣效性。意向治疗分析也证明了S-CSBI的非劣效性。在不良事件方面,两组均未观察到严重的全身毒性,S-CSBI组的血尿IIIa级较高,但无统计学意义。结论:TURBT术后S-CSBI的2年RFS率不低于L-CSBI。S-CSBI易于管理,特别是在日间手术中,可能是NMIBC患者的治疗选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Randomized Study of Short-time Continuous Saline Irrigation After Transurethral Resection in Non-muscle Invasive Bladder Cancer.

Background/aim: To investigate the efficacy and safety of short-time continuous saline bladder irrigation (S-CSBI) compared to long-time CSBI (L-CSBI) after transurethral resection of bladder tumor (TURBT) in non-muscle invasive bladder cancer (NMIBC).

Patients and methods: Between 2016 and 2021, 323 patients with suspected primary NMIBC based on cystoscopic appearance were enrolled. Patients were randomly allocated to receive S-CSBI (3 hours) or L-CSBI (overnight) after TURBT. Patients with the highest risk NMIBC and muscle-invasive bladder cancer were excluded. The primary endpoint was the 2-year recurrence-free survival (RFS) rate for S-CSBI, which was tested for non-inferiority. A difference of 15% in the 2-year RFS rate (60%) was defined as the non-inferiority margin for comparing the long-time CSBI.

Results: A total of 230 patients (110 in the S-CSBI group and 120 in the L-CSBI group) remained for the per-protocol analysis after exclusion. The 2-year RFS rates for S-CSBI and L-CSBI were 70.5% [95% confidence interval (CI)=60.9-78.2] and 70.5% (95%CI=61.4-77.9), respectively. The 95%CI for S-CSBI was above the lower non-inferiority limit of 60%, confirming the non-inferiority of S-CSBI to L-CSBI. The intention to treat analysis also demonstrated the non-inferiority of S-CSBI. In terms of adverse events, no severe systemic toxicities were observed in either group, hematuria grade IIIa was higher in the S-CSBI group, although not statistically significant.

Conclusion: S-CSBI after TURBT was non-inferior to L-CSBI with regard to the 2-year RFS rate. S-CSBI is easy to administer, especially in day surgery, and may be a treatment choice for patients with NMIBC.

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来源期刊
Anticancer research
Anticancer research 医学-肿瘤学
CiteScore
3.70
自引率
10.00%
发文量
566
审稿时长
2 months
期刊介绍: ANTICANCER RESEARCH is an independent international peer-reviewed journal devoted to the rapid publication of high quality original articles and reviews on all aspects of experimental and clinical oncology. Prompt evaluation of all submitted articles in confidence and rapid publication within 1-2 months of acceptance are guaranteed. ANTICANCER RESEARCH was established in 1981 and is published monthly (bimonthly until the end of 2008). Each annual volume contains twelve issues and index. Each issue may be divided into three parts (A: Reviews, B: Experimental studies, and C: Clinical and Epidemiological studies). Special issues, presenting the proceedings of meetings or groups of papers on topics of significant progress, will also be included in each volume. There is no limitation to the number of pages per issue.
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