Department of Preventive Medicine, College of Medicine, Chosun University, Gwangju, Korea.
Department of Urology, Rechtsder Isar Medical Center, Technical University of Munich, Munich, Germany.
Investig Clin Urol. 2021 Nov;62(6):623-630. doi: 10.4111/icu.20210265.
To assess the comparative effectiveness and toxicity of intravesical gemcitabine instillation for non-muscle invasive bladder cancer (NMIBC).
We performed a comprehensive literature search on 11 September 2020. We included RCTs in which participants received intravesical gemcitabine for primary or recurrent NMIBC. Two review authors independently assessed the included studies and extracted data for the primary outcomes (time to recurrence, time to progression, grade III to V adverse events) and the secondary outcomes (time to death from bladder cancer, time to death from any cause, grade I or II adverse events, and disease-specific quality of life). We performed statistical analyses using a random-effects model and rated the certainty of the evidence using GRADE.
We found seven studies with 1,222 participants. Gemcitabine may reduce the risk of recurrence over time, but may have a similar effect on progression and grade III to V adverse events compared to saline. Gemcitabine may reduce recurrence and progression compared to mitomycin. We are uncertain about the effect of gemcitabine on the grade III to V adverse events compared to mitomycin. Gemcitabine may reduce recurrence and progression compared to giving BCG again in recurrent high-risk NMIBC after BCG treatment.
Based on the findings of this review, gemcitabine may have a favorable impact on recurrence and progression-free survival than saline and mitomycin but we are uncertain about how major adverse events compare. The same is true when comparing gemcitabine to BCG in individuals with high-risk diseases who have previously failed BCG.
评估膀胱内吉西他滨灌注治疗非肌肉浸润性膀胱癌(NMIBC)的疗效和毒性。
我们于 2020 年 9 月 11 日进行了全面的文献检索。纳入了参与者接受膀胱内吉西他滨治疗初发或复发性 NMIBC 的 RCT。两位综述作者独立评估了纳入的研究并提取了主要结局(复发时间、进展时间、III 级至 V 级不良事件)和次要结局(膀胱癌死亡时间、任何原因死亡时间、I 级或 II 级不良事件、疾病特异性生活质量)的数据。我们使用随机效应模型进行统计分析,并使用 GRADE 评估证据的确定性。
我们发现了 7 项研究,共纳入 1222 名参与者。吉西他滨可能会降低复发的风险,但与生理盐水相比,对进展和 III 级至 V 级不良事件的影响可能相似。与丝裂霉素相比,吉西他滨可能会降低复发和进展的风险。与丝裂霉素相比,我们不确定吉西他滨对 III 级至 V 级不良事件的影响。与在 BCG 治疗后再次给予 BCG 治疗复发性高危 NMIBC 相比,吉西他滨可能会降低复发和进展的风险。
基于本综述的结果,吉西他滨在复发和无进展生存方面可能优于生理盐水和丝裂霉素,但我们不确定主要不良事件的比较情况。对于以前 BCG 治疗失败的高危疾病患者,吉西他滨与 BCG 相比也是如此。