英国癌症研究所发现,在肾输尿管切除术后90天内实施吉西他滨铂联合化疗可延长局部晚期上尿路上皮癌(UTUC)[1]患者的无病生存期。第三期POUT试验(NCT01993979)随机分配261例肾输尿管切除术后患者,只进行监测,或接受4个21天周期的辅助化疗。对于化疗组的参与者,在术后90天内开始治疗,包括吉西他滨-顺铂或吉西他滨-卡铂(肾功能受损患者)的联合治疗。随访以监测在相同频率的两组治疗中复发的迹象;即在4、7、10、13周,对应于每个化疗周期的结束。每次随访患者均接受影像学检查和膀胱镜检查。3年无病生存期包括主要终点;总生存期(OS)和患者报告的生活质量包括关键的次要终点。中位随访48.1个月,监测组129例患者中52例(40.3%),化疗组131例患者中41例(31.3%)死亡。研究人员报告化疗组3年无病生存率为71%,监测组为46%;化疗组3年OS率为79%,监测组为67%。 In the chemotherapy group, 44% of participants experienced grade ≥3 treatment-emergent adverse events, as compared with only 4% of participants in the surveillance group. These adverse events were consistent with those previously reported for this chemotherapy protocol. Chemotherapy did not have any long-term toxicity associated with it. There were no differences in quality of life outcomes between the groups. The improved DFS outcomes achieved by patients treated with platinum-based chemotherapy within 90 days post-nephroureterectomy have prompted researchers to recommend this protocol be considered a new standard of care for these UTUC patients [2].
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  1. Birtle AJ。POUT最新结果:一项上尿路上皮癌(UTUC)围手术期化疗与监测的III期随机试验。ASCO泌尿生殖癌研讨会,2021年2月11-13日。
  2. Birtle A等。柳叶刀。2020年4月18日;395(10232):1268-1277。