Lu Jun-Lin, Xia Qi-Dong, Liu Chen-Qian, Sun Jian-Xuan, Yang Yuan-Yuan, Hu Heng-Long, Wang Shao-Gang
Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Transl Cancer Res. 2021 Jun;10(6):2849-2858. doi: 10.21037/tcr-21-291.
We conducted a meta-analysis to compare the efficacy and toxicity of scheduled intravesical gemcitabine (GEM) and Bacille Calmette-Guérin (BCG) for Ta and T1 non-muscle invasive bladder cancer (NMIBC).
The database search was performed in Ovid Medline, Embase, Web of Science, Cochrane Library from the commencement of the database to July 7, 2020. Trials using immediate instillation were excluded and we present the included studies in accordance with the PRISMA 2020 reporting checklist. The data extracted was analyzed using Stata 11.0 software.
Six studies of 466 patients comparing GEM and BCG were finally included. No significant difference was detected between GEM and BCG group in recurrence free survival [hazard ratio (HR) =0.80, 95% confidence interval (95% CI), 0.46-1.37, P=0.410], progression free survival (HR =0.82, 95% CI, 0.38-1.77, P=0.621), and total adverse events [odds ratio (OR) =0.70, 95% CI, 0.38-1.29, P=0.253). However, patients receiving GEM treatment are less likely to develop urinary adverse events, such as dysuria (OR =0.50, 95% CI, 0.29-0.87) and hematuria (OR =0.40, 95% CI, 0.18-0.91). We performed subgroup analysis and found that the effects of GEM and BCG were similar even on patients with high recurrence risk tumor. Sensitivity analysis showed the robustness of the results.
Scheduled intravesical GEM instillation has a similar effect with BCG instillation in preventing NMIBC recurrence and progression, but GEM therapy causes a lower incidence of dysuria and hematuria than BCG. GEM may be an alternative therapy for BCG. However, the results should be treated with caution due to the low to moderate quality of the included studies.
我们进行了一项荟萃分析，以比较计划性膀胱内注射吉西他滨（GEM）和卡介苗（BCG）治疗Ta和T1期非肌层浸润性膀胱癌（NMIBC）的疗效和毒性。
在Ovid Medline、Embase、Web of Science、Cochrane图书馆进行数据库检索，检索时间从数据库建立至2020年7月7日。排除采用即刻灌注的试验，我们按照PRISMA 2020报告清单展示纳入的研究。使用Stata 11.0软件对提取的数据进行分析。
最终纳入6项研究，共466例比较GEM和BCG的患者。GEM组和BCG组在无复发生存率[风险比（HR）=0.80，95%置信区间（95%CI），0.46 - 1.37，P = 0.410]、无进展生存率（HR = 0.82，95%CI，0.38 - 1.77，P = 0.621）和总不良事件[比值比（OR）=0.70，95%CI，0.38 - 1.29，P = 0.253]方面未检测到显著差异。然而，接受GEM治疗的患者发生尿痛（OR = 0.50，95%CI，0.29 - 0.87）和血尿（OR = 0.40，95%CI，0.18 - 0.91）等泌尿系统不良事件的可能性较小。我们进行了亚组分析，发现即使对于高复发风险肿瘤患者，GEM和BCG的效果也相似。敏感性分析显示结果具有稳健性。
计划性膀胱内注射GEM在预防NMIBC复发和进展方面与BCG注射效果相似，但GEM治疗引起的尿痛和血尿发生率低于BCG。GEM可能是BCG的替代疗法。然而，由于纳入研究的质量为低到中等，结果应谨慎对待。
