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单月卡介苗膀胱内灌注是预防日本非肌肉浸润性膀胱癌患者复发的有效维持治疗方法。

Single monthly bacillus Calmette-Guérin intravesical instillation is effective maintenance therapy to prevent recurrence in Japanese patients with non-muscle-invasive bladder cancer.

机构信息

Department of Urology, J A Aichi Anjo Kosei Hospital, 28 Higashihirokute, Anjo-cho, Anjo 446-8602, Japan.

出版信息

Int J Clin Oncol. 2012 Oct;17(5):477-81. doi: 10.1007/s10147-011-0314-3. Epub 2011 Sep 28.

DOI:10.1007/s10147-011-0314-3
PMID:21947596
Abstract

BACKGROUND

A series of bacillus Calmette-Guérin (BCG) bladder instillations is the gold standard therapy to prevent recurrence after transurethral resection of bladder tumor (TUR-Bt) of non-muscle-invasive bladder cancer (NMIBC). However, in some cases the outcome is not optimal with the standard 6- to 8-week protocol and therefore interest has focused on additional maintenance therapy. The present study was conducted to assess the utility of single monthly intravesical instillation treatments for up to 1 year in Japanese patients.

METHODS

A total of 75 stage Ta and T1 patients who had undergone TUR-Bt were retrospectively evaluated, all first receiving 80 mg BCG (Tokyo 172 strain) given once a week, 6-8 times, for primary prophylaxis. Comparison was then made of groups with (group A, 48 patients) and without (group B, 27 patients) additional maintenance BCG therapy given once a month 6-8 times.

RESULTS

Recurrence-free survival rates at 5 years in groups A and B were 83.0 and 51.9% (P = 0.006), despite the greater proportion of T1 patients and the longer follow-up period in the group A patients. Significant protection against recurrence persisted on multivariate analysis with adjustment for age, stage, grade, and tumor number.

CONCLUSIONS

These findings indicate maintenance BCG therapy of single intravesical instillations given once a month with our protocol to be definitely effective for prophylactic use, especially in stage Ta patients. Further evaluation of parameters such as the continuance period and dose protocol is warranted.

摘要

背景

一系列的卡介苗膀胱内灌注是预防经尿道膀胱肿瘤切除术(TUR-Bt)后非肌肉浸润性膀胱癌(NMIBC)复发的金标准治疗方法。然而,在某些情况下,标准的 6-8 周方案的效果并不理想,因此人们对额外的维持治疗产生了兴趣。本研究旨在评估在日本患者中单次每月膀胱内灌注治疗长达 1 年的效果。

方法

共回顾性评估了 75 例 Ta 和 T1 期患者,所有患者均首先接受 80mg BCG(东京 172 株)每周一次,共 6-8 次,进行初级预防。然后比较了接受(A 组,48 例)和未接受(B 组,27 例)额外每月一次 BCG 治疗的两组患者。

结果

A 组和 B 组患者的 5 年无复发生存率分别为 83.0%和 51.9%(P=0.006),尽管 A 组患者中 T1 期患者比例较高,随访时间较长。多因素分析显示,在调整了年龄、分期、分级和肿瘤数量后,复发的保护作用仍然显著。

结论

这些发现表明,我们的方案中单次每月膀胱内灌注维持 BCG 治疗对预防复发绝对有效,特别是在 Ta 期患者中。需要进一步评估持续时间和剂量方案等参数。

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