[Prospective controlled observation ofeffect of adjuvant chemotherapy onsurvival and prognosis ofhigh-risk upper tract urothelial carcinoma patients underwent radical nephroureterectomy].

Objective: To assess the oncologic outcomes of radical nephroureterectomy (RNU) combined with adjuvant chemotherapy (ACT) in patients with high risk upper tract urothelial carcinoma (UTUC). Methods: From January 2014, all high-risk UTUC patients after RNU surgery were enrolled in this prospective comparative trial. And these patients were randomized to ACT group (Gemcitabine+Cisplatin three weeks regimen) and observing group. Cox proportional hazard modeling and Kaplan-Meier analysis were used to determine overall survival (OS), cancer specific survival (CSS) and disease-free survival (PFS) in the cohort. Results: The median follow-up duration was36 months (range: 6-54) in the ACT group (n=94) and 30 months (range: 6-54) in the observing group (n=82). Oncologic outcomes of RNU treated high-risk UTUC patients were improved much significantly by ACT: OS [P=0.0397, HR: 1.39(0.91-1.75)], CSS [P=0.0255, HR: 1.26(1.07-1.45)] and PFS [P=0.0033, HR: 3.78(3.13-4.55)]. The further analysis in lymph node positive cohort displayed that median times of oncologic events were prolonged in the ACT group compared with the observing group: OS (26.8mon vs 36.3mon, P=0.0255), CSS (28.2mon vs39.3mon, P=0.0197) and PFS (11.4mon vs 31.9mon, P=0.0018). Additionally in T3/4 cohort, the significant growth in the median times of OS (20.6mon vs 32.2mon, P=0.0183), CSS (21.9mon vs 38.4mon, P=0.0226) and PFS (13.9mon vs 36.3mon, P=0.0217) were observed in ACT group. Conclusion: ACT could play the important synergistic role in improving the OS, CSS and PFS of high-risk UTUC patients after RNU.

目的: 探讨根治性肾输尿管切除术(RNU)后辅助化疗对高危上尿路尿路上皮癌(UTUC)患者的生存预后的影响。 方法: 采用前瞻性随机对照研究方法,将2014年1月起收治的接受RNU治疗的高危UTUC患者,按照随机分为两组:化疗组和对照组。其中,化疗组患者于根治术后1个月开始进行3个周期的吉西他滨+顺铂(GC)3周化疗方案,对照组患者则未行术后辅助治疗、进行常规影像学随访。观察化疗临床反应,并对比总结两组患者的总体生存率(OS)、肿瘤特异生存率(CSS)及疾病无进展生存率(PFS),评价辅助化疗(ACT)对UTUC患者的预后影响。 结果: 化疗组患者94例,中位年龄64岁,男37例、女57例,对照组入组患者82例,中位年龄67岁,男31例、女51例。所有化疗患者均未观察到WHO3级及以上肾功能毒性反应。化疗组和对照组的中位随访时间分别为36个月和30个月(P=0.67)。ACT显著改善高危UTUC患者RNU术后OS(P=0.0397,)、CSS(P=0.0255)及PFS(P=0.0033)。分层分析显示:ACT改善淋巴结阳性UTUC患者的预后:中位OS延长9.5个月(P=0.0255)、中位CSS延长11.1个月(P=0.0197)、中位PFS延长20.5个月(P=0.0018);此外,ACT延长T3/4期UTUC患者中位OS 11.6个月(P=0.0183)、中位CSS 16.5个月(P=0.0226)、中位PFS 22.4个月(P=0.0217)。 结论: ACT是一项安全有效的治疗措施,对RNU术后高危UTUC患者具有显著改善预后的应用价值。.

Zhonghua yi xue za zhi. 2019 Oct 29 [Epub]

Y Luo, B F Feng, D C Wei, Y L Han, M C Li, J H Zhao, Y H Lin, Q Li, Z Hou, G Y Zhang, Y G Jiang

Department of Urology, Beijing Anzhen hospital, Capital Medical University, Beijing, 100029, China.