Hwang Eu Chang, Sathianathen Niranjan J, Jung Jae Hung, Kim Myung Ha, Dahm Philipp, Risk Michael C
Department of Urology, Chonnam National University Medical School, Chonnam National University Hwasun Hospital, Hwasun, Korea, South.
Cochrane Database Syst Rev. 2019 May 18;5(5):CD013160. doi: 10.1002/14651858.CD013160.pub2.
Single-dose, postoperative intravesical chemotherapy reduces the risk of bladder cancer recurrence after transurethral resection of bladder tumours. However, there is limited evidence whether single-dose intravesical chemotherapy is similarly effective at preventing bladder cancer recurrence after nephroureterectomy.
To assess the effects of single-dose intravesical chemotherapy instillation after nephroureterectomy for upper tract urothelial carcinoma.
We performed a comprehensive literature search using multiple databases (MEDLINE, Cochrane Library, Embase, Scopus, Web of Science, and LILACS), trials registries, other sources of grey literature, and conference proceedings published up to April 15 2019, with no restrictions on language or status of publication.
We included randomised controlled trials in which participants either received or did not receive single-dose intravesical chemotherapy instillation after nephroureterectomy.
Two review authors screened and independently assessed studies and extracted data from included studies. We performed statistical analyses using a random-effects model. We rated the certainty of evidence according to the GRADE approach.
The search identified two studies (a multicenter study from Japan and the United Kingdom) with 361 participants.Primary outcomesOur results indicate that single-dose intravesical chemotherapy instillation may reduce the risk of bladder cancer recurrence over time compared to no instillation (hazard ratio [HR]: 0.51, 95% confidence interval [CI]: 0.32 to 0.82, low-certainty evidence). After 12 months follow-up, this would result in 127 fewer bladder cancer recurrences (95% CI: 182 to 44 fewer bladder cancer recurrences) per 1000 participants. We downgraded the certainty of evidence by two levels due to study limitations and imprecision.We found no trials that reported on the outcomes of time to death from upper tract urothelial carcinoma. The effect of single-dose intravesical chemotherapy instillation on serious adverse events is uncertain (risk ratio [RR]: not estimable, 95% CI: not estimable, there were no events, very low-certainty evidence). We downgraded the certainty of evidence by one level due to study limitations and by two levels due to imprecision.Secondary outcomesWe found no trials that reported on the outcomes of time to death from any cause and participants' disease-specific quality of life. The effect of single-dose intravesical chemotherapy instillation on minor adverse events is uncertain (risk ratio [RR]: not estimable, 95% CI: not estimable, there were no events, very low-certainty evidence). We downgraded the certainty of evidence by one level due to study limitations and by two levels due to imprecision.
AUTHORS' CONCLUSIONS: For patients who have undergone nephroureterectomy for upper tract urothelial carcinoma, single-dose intravesical chemotherapy instillation may reduce bladder cancer recurrence after nephroureterectomy. However, we are uncertain as to the risk of serious (and minor) adverse events. We found no evidence for the outcome of time to death from upper tract urothelial carcinoma. We were unable to conduct any of the preplanned subgroup analyses, particularly those based on operative approach, pathologic stage, and method of bladder cuff excision.
单剂量术后膀胱内化疗可降低经尿道膀胱肿瘤切除术后膀胱癌复发的风险。然而,关于单剂量膀胱内化疗在预防肾盂输尿管切除术后膀胱癌复发方面是否同样有效,证据有限。
评估肾盂输尿管切除术后单剂量膀胱内化疗灌注对上尿路尿路上皮癌的影响。
我们使用多个数据库(MEDLINE、Cochrane图书馆、Embase、Scopus、Web of Science和LILACS)、试验注册库、其他灰色文献来源以及截至2019年4月15日发表的会议论文集进行了全面的文献检索,对语言或出版状态无限制。
我们纳入了随机对照试验,其中参与者在肾盂输尿管切除术后接受或未接受单剂量膀胱内化疗灌注。
两位综述作者筛选并独立评估研究,并从纳入的研究中提取数据。我们使用随机效应模型进行统计分析。我们根据GRADE方法对证据的确定性进行评级。
检索确定了两项研究(一项来自日本和英国的多中心研究),共361名参与者。
我们的结果表明,与未进行灌注相比,单剂量膀胱内化疗灌注可能会随着时间的推移降低膀胱癌复发的风险(风险比[HR]:0.51,95%置信区间[CI]:0.32至0.82,低确定性证据)。随访12个月后,每1000名参与者中膀胱癌复发将减少127例(95%CI:减少182至44例膀胱癌复发)。由于研究局限性和不精确性,我们将证据的确定性降低了两个等级。我们未发现报告上尿路尿路上皮癌死亡时间结局的试验。单剂量膀胱内化疗灌注对严重不良事件的影响尚不确定(风险比[RR]:无法估计,95%CI:无法估计,无事件发生,极低确定性证据)。由于研究局限性,我们将证据的确定性降低了一个等级,由于不精确性,降低了两个等级。
我们未发现报告任何原因死亡时间和参与者疾病特异性生活质量结局的试验。单剂量膀胱内化疗灌注对轻微不良事件的影响尚不确定(风险比[RR]:无法估计,95%CI:无法估计,无事件发生,极低确定性证据)。由于研究局限性,我们将证据的确定性降低了一个等级,由于不精确性,降低了两个等级。
对于接受过上尿路尿路上皮癌肾盂输尿管切除术的患者,单剂量膀胱内化疗灌注可能会降低肾盂输尿管切除术后膀胱癌的复发率。然而,我们不确定严重(和轻微)不良事件的风险。我们未找到上尿路尿路上皮癌死亡时间结局的证据。我们无法进行任何预先计划的亚组分析,特别是那些基于手术方式、病理分期和膀胱袖口切除方法的分析。