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日本非肌肉浸润性膀胱癌患者行卡介苗膀胱内灌注治疗的真实世界治疗模式和临床结局。

Real-world treatment patterns and clinical outcomes of Japanese patients with non-muscle invasive bladder cancer receiving intravesical bacillus Calmette-Guérin treatment.

机构信息

Department of Urology, Nara Medical University, Nara, Japan.

Department of Urology, St. Marianna University School of Medicine, Kanagawa, Japan.

出版信息

Int J Urol. 2022 Oct;29(10):1120-1129. doi: 10.1111/iju.14933. Epub 2022 May 21.

Abstract

OBJECTIVES

To investigate current patterns and outcomes of intravesical bacillus Calmette-Guérin treatment in Japanese patients with bladder cancer, including the proportion of patients completing induction therapy, and time to subsequent treatments.

METHODS

This retrospective cohort study utilized administrative claims data from the Medical Data Vision Co., Ltd. database to identify patients with a diagnosis of bladder cancer who had received ≥1 prescription of intravesical bacillus Calmette-Guérin between April 2008 and September 2015, and had ≥1 database record dated ≥12 weeks after the initial bacillus Calmette-Guérin dose. Patients were followed until September 2018, the last date of available data, or in-hospital death. Patients receiving six doses of bacillus Calmette-Guérin at intervals of <21 days were considered to have completed induction according to guidelines. Time from initial bacillus Calmette-Guérin dose to subsequent bladder cancer treatment after the end of treatment was defined as the recurrence-free duration.

RESULTS

Of 6140 patients identified (median age 73.0 years; 83.4% males), 4588 (74.7%) completed induction and 1552 (25.3%) did not. Median recurrence-free duration was 64.4, 77.7, and 31.6 months in the overall, complete-induction and incomplete-induction cohorts, respectively. Corresponding 3-year recurrence-free rate was 56.3%, 59.0%, and 48.2% in these groups. The rate of cystectomy was approximately 6% at 5 years in all cohorts.

CONCLUSIONS

Approximately 75% of Japanese patients who undergo intravesical bacillus Calmette-Guérin treatment receive a guideline-compliant induction regimen, but outcomes were not satisfactory, highlighting the need for more effective treatments for non-muscle invasive bladder cancer.

摘要

目的

调查日本膀胱癌患者膀胱内卡介苗治疗的现状和结局,包括完成诱导治疗的患者比例以及后续治疗的时间。

方法

本回顾性队列研究利用 Medical Data Vision Co., Ltd. 数据库中的行政索赔数据,确定了 2008 年 4 月至 2015 年 9 月期间接受过≥1 次膀胱内卡介苗治疗且在初始卡介苗剂量后至少有 1 个数据库记录日期≥12 周的膀胱癌诊断患者。患者随访至 2018 年 9 月(最后可用数据日期)或住院死亡。根据指南,间隔<21 天接受 6 剂卡介苗的患者被认为完成了诱导。治疗结束后至后续膀胱癌治疗的时间定义为无复发生存期。

结果

在确定的 6140 例患者中(中位年龄 73.0 岁;男性占 83.4%),4588 例(74.7%)完成了诱导,1552 例(25.3%)未完成。在整个队列、完全诱导和不完全诱导队列中,中位无复发生存期分别为 64.4、77.7 和 31.6 个月。相应的 3 年无复发生存率分别为 56.3%、59.0%和 48.2%。在所有队列中,5 年内膀胱切除术的发生率约为 6%。

结论

接受膀胱内卡介苗治疗的日本患者中,约 75%接受了符合指南的诱导方案,但结局并不令人满意,这突出表明需要为非肌肉浸润性膀胱癌提供更有效的治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c324/9790662/5455ecc8227a/IJU-29-1120-g005.jpg

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