Prospective Randomized Phase II Trial of a Single Early Intravesical Instillation of Pirarubicin (THP) in the Prevention of Bladder Recurrence After Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma: The THP Monotherapy Study Group Trial
Prospective Randomized Phase II Trial of a Single Early Intravesical Instillation of Pirarubicin (THP) in the Prevention of Bladder Recurrence After Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma: The THP Monotherapy Study Group Trial
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DOI：
10.1200/jco.2012.45.2128
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发表时间：
2013-04-10
影响因子：
45.3
通讯作者：
Arai, Yoichi
中科院分区：
文献类型：
--
作者：
Ito, Akihiro;Shintaku, Ichiro;Arai, Yoichi
目的我们评估了早期单次膀胱灌注吡拉齐（THP）预防上尿路尿路上皮癌（UUT-UC）肾输尿管切除术后膀胱复发的疗效。来自参与东北泌尿学证据的11家机构的77名临床诊断为UUT-UC的患者-基础医学研究组术前入组本研究。在肾输尿管切除术后48小时内，患者被随机分配接受或不接受THP（30 mg溶于30 mL生理盐水中）单次膀胱灌注。膀胱镜检查和尿细胞学检查重复每3个月为2年或直到第一次膀胱recurrence. Results 72例患者的疗效分析，其中21人有随后的膀胱复发的发生。与对照组相比，接受THP治疗的患者复发率显著更低（THP组1年时为16.9%，2年时为16.9%，对照组1年时为31.8%，2年时为42.2%;对数秩P = 0.025）。THP治疗组未见明显不良反应。基于多变量分析，THP滴注（风险率[HR]，0.26; 95% CI，0.07 - 0.91; P = 0.035）和开放手术（HR，0.28; 95% CI，0.09 - 0.84; P = 0.024）是膀胱复发率降低的独立预测因素。单次膀胱灌注THP似乎可减少肾输尿管切除术后膀胱复发。需要一项III期、大规模、多中心研究来证实这些观察结果。J Clin Oncol 31：1422-1427. (C)2013年美国临床肿瘤学会
PurposeWe evaluated the efficacy of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma (UUT-UC).Patients and MethodsFrom December 2005 to November 2008, 77 patients clinically diagnosed with UUT-UC from 11 institutions participating in the Tohoku Urological Evidence-Based Medicine Study Group were preoperatively enrolled in this study. Patients were randomly assigned to receive or not receive a single instillation of THP (30 mg in 30 mL of saline) into the bladder within 48 hours after nephroureterectomy. Cystoscopy and urinary cytology were repeated every 3 months for 2 years or until the occurrence of first bladder recurrence.ResultsSeventy-two patients were evaluable for efficacy analysis, 21 of whom had a subsequent bladder recurrence. Significantly fewer patients who received THP had a recurrence compared with the control group (16.9% at 1 year and 16.9% at 2 years in the THP group v 31.8% at 1 year and 42.2% at 2 years in the control group; log-rank P = .025). No remarkable adverse events were observed in the THP-treated group. Based on multivariate analysis, THP instillation (hazard rate [HR], 0.26; 95% CI, 0.07 to 0.91; P = .035) and open surgery (HR, 0.28; 95% CI, 0.09 to 0.84; P = .024) were independently predictive of a reduced incidence of bladder recurrence.ConclusionIn this prospective randomized phase II study, a single intravesical instillation of THP seemed to reduce bladder recurrence after nephroureterectomy. A phase III, large-scale, multicenter study is needed to confirm these observations. J Clin Oncol 31:1422-1427. (C) 2013 by American Society of Clinical Oncology