Bologna Eugenio, Wu Zhenjie, Franco Antonio, Abdollah Firas, Finati Marco, Simone Giuseppe, Tuderti Gabriele, Licari Leslie Claire, Correa Andres F, Lee Randall, De Cobelli Ottavio, Ferro Matteo, Porpiglia Francesco, Amparore Daniele, Checcucci Enrico, Tufano Antonio, Perdonà Sisto, Bhanvadia Raj, Margulis Vitaly, Brönimann Stephan, Singla Nirmish, Puri Dhruv, Derweesh Ithaar H, Mendiola Dinno F, Gonzalgo Mark L, Ben-David Reuben, Mehrazin Reza, Moon Sol C, Rais-Bahrami Soroush, Yong Courtney, Sundaram Chandru P, Ghoreifi Alireza, Moghaddam Farshad S, Djaladat Hooman, Ditonno Francesco, Antonelli Alessandro, Autorino Riccardo
Department of Urology, Rush University Medical Center, Chicago, IL, USA.
Department of Urology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.
Asian J Urol. 2025 Apr;12(2):250-257. doi: 10.1016/j.ajur.2024.10.006. Epub 2025 Jan 9.
Radical nephroureterectomy (RNU) is considered the standard of care for patients with high-risk upper tract urothelial carcinoma. Current literature reveals a deficit in direct comparative studies evaluating the efficacy of different chemotherapeutic agents administered in single postoperative instillation following RNU. The primary aim of this study was to compare the bladder recurrence (BR) rates between patients receiving a single instillation of mitomycin C (MMC) versus gemcitabine (Gem) after RNU.
The ROBUUST (ROBotic surgery for Upper tract Urothelial cancer STudy) 2.0 is an international, multicenter registry that aggregates data on patients who have undergone curative surgery for upper tract urothelial carcinoma across participating centers from January 2015 to December 2022. Data including primary baseline variables of the patients, characteristics of the tumors, surgical management, and definitive histopathological characterizations were collected and stratified based on the type of postoperative bladder instillation: MMC (the MMC group) and Gem (the Gem group). We selected variables correlated with our primary outcome to conduct a propensity-score match analysis.
One hundred patients in the MMC group were matched 1:1 with 100 patients in the Gem group. At 36 months of follow-up, 30 patients in the MMC group and 39 patients in the Gem group experienced BR, representing recurrence rates of 30% and 39%, respectively (=0.2). The Cox proportional hazards model comparing BR between the groups revealed a hazard ratio of 1.58 (95% confidence interval: 0.98-2.55) with a non-statistically significant increased risk of BR in the Gem group compared with the MMC group (=0.059).
A single perioperative instillation of Gem or MMC seems to offer similar efficacy in reducing the risk of BR in patients undergoing RNU. Further research, ideally within the framework of prospective studies, is warranted to elucidate the optimal chemotherapeutic approach in this setting.
根治性肾输尿管切除术（RNU）被认为是高危上尿路尿路上皮癌患者的标准治疗方法。当前文献显示，在评估RNU术后单次膀胱灌注不同化疗药物疗效的直接对比研究方面存在不足。本研究的主要目的是比较RNU术后接受单次丝裂霉素C（MMC）灌注与吉西他滨（Gem）灌注患者的膀胱复发（BR）率。
ROBUUST（上尿路尿路上皮癌机器人手术研究）2.0是一项国际多中心注册研究，汇总了2015年1月至2022年12月期间参与中心接受上尿路尿路上皮癌根治性手术患者的数据。收集包括患者的主要基线变量、肿瘤特征、手术管理和明确的组织病理学特征等数据，并根据术后膀胱灌注类型进行分层：MMC（MMC组）和Gem（Gem组）。我们选择与主要结局相关的变量进行倾向评分匹配分析。
MMC组100例患者与Gem组100例患者进行1:1匹配。随访36个月时，MMC组30例患者和Gem组39例患者发生BR，复发率分别为30%和39%（=0.2）。比较两组BR的Cox比例风险模型显示，风险比为1.58（95%置信区间：0.98 - 2.55），Gem组与MMC组相比，BR风险虽有增加但无统计学意义（=0.059）。
围手术期单次灌注Gem或MMC在降低RNU患者BR风险方面似乎具有相似疗效。有必要进行进一步研究，理想情况下是在前瞻性研究框架内，以阐明这种情况下的最佳化疗方法。
