Kawada Tatsushi, Yanagisawa Takafumi, Araki Motoo, Pradere Benjamin, Shariat Shahrokh F
Department of Urology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria.
Department of Urology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama.
Curr Opin Urol. 2023 May 1;33(3):211-218. doi: 10.1097/MOU.0000000000001065. Epub 2022 Dec 23.
Shortages in intravesical Bacillus Calmette-Guérin (BCG) immunotherapy represent a challenge in the management of high-risk nonmuscle invasive bladder cancer (HR-NMIBC). This study aimed to review the efficacy and safety of intravesical gemcitabine (GEM) and docetaxel (DOCE) for BCG-naive and unresponsive HR-NMIBC.
We identified six studies eligible for quantitative analysis through a systematic search according to the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) statement. In the two studies in the BCG-naive setting, 1-year and 2-year pooled recurrence-free survival (RFS) were 86 and 84%, respectively. In the two studies in the BCG unresponsive setting, 6-month, 1-year and 2-year pooled high-grade recurrence-free survival (HG-RFS) were 80, 66 and 51%, respectively. Cumulative data from four studies revealed that 2.3% of patients could not complete induction therapy and 6.9% experienced treatment delay or dose reduction due to adverse events.
Despite the preliminary data and based on a small sample size, intravesical GEM/DOCE therapy is a highly promising combination yielding an effective and well tolerated alternative to BCG when indicated. Further large, well designed comparative studies with BCG are needed.
膀胱内灌注卡介苗(BCG)免疫疗法的短缺是高危非肌层浸润性膀胱癌(HR-NMIBC)管理中的一项挑战。本研究旨在回顾膀胱内吉西他滨(GEM)和多西他赛(DOCE)用于初治及对BCG无反应的HR-NMIBC的疗效和安全性。
我们根据系统评价和Meta分析的首选报告项目(PRISMA)声明进行系统检索,确定了六项符合定量分析条件的研究。在两项初治BCG的研究中,1年和2年的汇总无复发生存率(RFS)分别为86%和84%。在两项BCG无反应的研究中,6个月、1年和2年的汇总高级别无复发生存率(HG-RFS)分别为80%、66%和51%。四项研究的累积数据显示,2.3%的患者无法完成诱导治疗,6.9%的患者因不良事件出现治疗延迟或剂量减少。
尽管数据初步且样本量小,但膀胱内GEM/DOCE疗法是一种非常有前景的联合疗法,在有指征时可作为BCG的有效且耐受性良好的替代方案。需要进一步开展与BCG的大型、设计良好的对比研究。