Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial
Adjuvant chemotherapy in upper tract urothelial carcinoma (the POUT trial): a phase 3, open-label, randomised controlled trial
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DOI：
10.1016/s0140-6736(20)30415-3
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发表时间：
2020-04-18
期刊：
影响因子：
168.9
通讯作者：
Hall, Emma
中科院分区：
文献类型：
--
作者：
Birtle, Alison;Johnson, Mark;Hall, Emma
研究背景上尿路上皮癌(UTUCs)是一种罕见的肿瘤，其分期预后比膀胱尿路上皮癌差。对于有治疗意图的肾输尿管切除术后UTUCs患者辅助化疗的益处，国际上尚无共识。POUT(上尿路上皮癌围手术期化疗与监测)试验旨在评估以铂为基础的全身化疗对输尿管上皮癌患者的疗效。方法我们在英国71家医院进行了一项3期开放标签随机对照试验。我们招募了肾输尿管切除术后的UTUC患者，分期为pt2-T4 pN0-N3 M0或pTany N1-3 M0。我们使用带有随机元素的最小化算法，将参与者集中(1：1)随机分配到监视或四个21天周期的化疗中。化疗方案为顺铂(70 mg/m(2))或卡铂(曲线下面积[AUC]4.5/AUC5，肾小球滤过率
Background Urothelial carcinomas of the upper urinary tract (UTUCs) are rare, with poorer stage-for-stage prognosis than urothelial carcinomas of the urinary bladder. No international consensus exists on the benefit of adjuvant chemotherapy for patients with UTUCs after nephroureterectomy with curative intent. The POUT (Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer) trial aimed to assess the efficacy of systemic platinum-based chemotherapy in patients with UTUCs.Methods We did a phase 3, open-label, randomised controlled trial at 71 hospitals in the UK. We recruited patients with UTUC after nephroureterectomy staged as either pT2-T4 pN0-N3 M0 or pTany N1-3 M0. We randomly allocated participants centrally (1:1) to either surveillance or four 21-day cycles of chemotherapy, using a minimisation algorithm with a random element. Chemotherapy was either cisplatin (70 mg/m(2)) or carboplatin (area under the curve [AUC]4.5/AUC5, for glomerular filtration rate