Systematic Review and Individual Patient Data Meta-analysis of Randomized Trials Comparing a Single Immediate Instillation of Chemotherapy After Transurethral Resection with Transurethral Resection Alone in Patients with Stage pTa-pT1 Urothelial Carcinoma of the Bladder: Which Patients Benefit from the Instillation?
Systematic Review and Individual Patient Data Meta-analysis of Randomized Trials Comparing a Single Immediate Instillation of Chemotherapy After Transurethral Resection with Transurethral Resection Alone in Patients with Stage pTa-pT1 Urothelial Carcinoma of the Bladder: Which Patients Benefit from the Instillation?
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DOI：
10.1016/j.eururo.2015.05.050
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发表时间：
2016-02-01
期刊：
影响因子：
23.4
通讯作者：
Babjuk, Marek
中科院分区：
文献类型：
--
作者：
Sylvester, Richard J.;Oosterlinck, Willem;Babjuk, Marek
内容：欧洲泌尿外科协会非肌层浸润性膀胱癌（NMIBC）指南建议所有低危和中危患者在经尿道膀胱切除术（TURB）后接受单次立即灌注化疗，但其使用仍存在争议。目的：确定哪些NMIBC患者受益于单次立即灌注。证据获取：对比较TURB后单次滴注与单纯TURB治疗NMIBC患者疗效的随机试验进行了系统回顾和个体患者数据（IPD）荟萃分析。获得了11项研究的IPD，随机分配了2278例合格患者，1161例接受TURB，1117例接受单次滴注表阿霉素、丝裂霉素C、吡拉托品或噻替派。共有1128例复发，108例进展和460例死亡（59例死于膀胱癌[BCa]）。单次滴注可将复发风险降低35%（风险比[HR]：0.65; 95%置信区间[CI]，0.58-0.74; p < 0.001），5年复发率从58.8%降至44.8%。对于既往复发率超过每年一次的患者或欧洲癌症研究与治疗组织（EORTC）复发评分>= 5的患者，滴注没有减少复发。滴注没有延长BCa的进展时间或死亡时间，但它导致死亡的总体风险增加（HR：1.26; 95% CI，1.05-1.51; p = 0.015; 5年死亡率12.0% vs 11.2%），差异出现在EORTC复发评分>= 5的患者中。单次立即滴注可降低复发风险，但既往复发率超过每年一次或EORTC复发评分≥ 5的患者除外。它不会延长BCa的进展或死亡时间。灌注可能与高复发风险患者的死亡风险增加相关，其中灌注无效或不推荐。患者总结：切除术后立即单次灌注化疗可降低非肌层浸润性膀胱癌的复发风险;然而，由于其在该亚组中缺乏疗效，因此不应给予高复发风险患者。(C)2015年欧洲泌尿外科协会。Elsevier B. V.出版，保留所有权利。
Context: The European Association of Urology non-muscle-invasive bladder cancer (NMIBC) guidelines recommend that all low-and intermediate-risk patients receive a single immediate instillation of chemotherapy after transurethral resection of the bladder (TURB), but its use remains controversial.Objective: To identify which NMIBC patients benefit from a single immediate instillation.Evidence acquisition: A systematic review and individual patient data (IPD) meta-analysis of randomized trials comparing the efficacy of a single instillation after TURB with TURB alone in NMIBC patients was carried out.Evidence synthesis: A total of 13 eligible studies were identified. IPD were obtained for 11 studies randomizing 2278 eligible patients, 1161 to TURB and 1117 to a single instillation of epirubicin, mitomycin C, pirarubicin, or thiotepa. A total of 1128 recurrences, 108 progressions, and 460 deaths (59 due to bladder cancer [BCa]) occurred. A single instillation reduced the risk of recurrence by 35% (hazard ratio [HR]: 0.65; 95% confidence interval [CI], 0.58-0.74; p < 0.001) and the 5-yr recurrence rate from 58.8% to 44.8%. The instillation did not reduce recurrences in patients with a prior recurrence rate of more than one recurrence per year or in patients with an European Organization for Research and Treatment of Cancer (EORTC) recurrence score >= 5. The instillation did not prolong either the time to progression or death from BCa, but it resulted in an increase in the overall risk of death (HR: 1.26; 95% CI, 1.05-1.51; p = 0.015; 5-yr death rates 12.0% vs 11.2%), with the difference appearing in patients with an EORTC recurrence score >= 5.Conclusions: A single immediate instillation reduced the risk of recurrence, except in patients with a prior recurrence rate of more than one recurrence per year or an EORTC recurrence score >= 5. It does not prolong either time to progression or death from BCa. The instillation may be associated with an increase in the risk of death in patients at high risk of recurrence in whom the instillation is not effective or recommended.Patient summary: A single instillation of chemotherapy immediately after resection reduces the risk of recurrence in non-muscle-invasive bladder cancer; however, it should not be given to patients at high risk of recurrence due to its lack of efficacy in this subgroup. (C) 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.