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荷兰机器人辅助与开放性根治性膀胱切除术治疗肌层浸润性和高危非肌层浸润性膀胱癌的中期生存比较。

Intermediate-term survival of robot-assisted versus open radical cystectomy for muscle-invasive and high-risk non-muscle invasive bladder cancer in The Netherlands.

机构信息

Department of Urology, Amsterdam University Medical Centres location Vrije University Medical Centre, Amsterdam, The Netherlands.

Department of Urology, Erasmus Medical Centre, Rotterdam, The Netherlands.

出版信息

Urol Oncol. 2022 Feb;40(2):60.e1-60.e9. doi: 10.1016/j.urolonc.2021.06.018. Epub 2021 Jul 22.

DOI:10.1016/j.urolonc.2021.06.018
PMID:34303597
Abstract

BACKGROUND

Radical cystectomy with pelvic lymph node dissection is the recommended treatment in non-metastatic muscle-invasive bladder cancer (MIBC). In randomised trials, robot-assisted radical cystectomy (RARC) showed non-inferior short-term oncological outcomes compared with open radical cystectomy (ORC). Data on intermediate and long-term oncological outcomes of RARC are limited.

OBJECTIVE

To assess the intermediate-term overall survival (OS) and recurrence-free survival (RFS) of patients with MIBC and high-risk non-MIBC (NMIBC) who underwent ORC versus RARC in clinical practice.

METHODS AND MATERIALS

A nationwide retrospective study in 19 Dutch hospitals including patients with MIBC and high-risk NMIBC treated by ORC (n = 1086) or RARC (n = 386) between January 1, 2012 and December 31, 2015. Primary and secondary outcome measures were median OS and RFS, respectively. Survival outcomes were estimated using Kaplan-Meier curves. A multivariable Cox regression model was developed to adjust for possible confounders and to assess prognostic factors for survival including clinical variables, clinical and pathological disease stage, neoadjuvant therapy and surgical margin status.

RESULTS

The median follow-up was 5.1 years (95% confidence interval ([95%CI] 5.0-5.2). The median OS after ORC was 5.0 years (95%CI 4.3-5.6) versus 5.8 years after RARC (95%CI 5.1-6.5). The median RFS was 3.8 years (95%CI 3.1-4.5) after ORC versus 5.0 years after RARC (95%CI 3.9-6.0). After multivariable adjustment, the hazard ratio for OS was 1.00 (95%CI 0.84-1.20) and for RFS 1.08 (95%CI 0.91-1.27) of ORC versus RARC. Patients who underwent ORC were older, had higher preoperative serum creatinine levels and more advanced clinical and pathological disease stage.

CONCLUSION

ORC and RARC resulted in similar intermediate-term OS and RFS in a cohort of almost 1500 MIBC and high-risk NMIBC.

摘要

背景

根治性膀胱切除术联合盆腔淋巴结清扫术是治疗非转移性肌层浸润性膀胱癌(MIBC)的推荐方法。在随机试验中,机器人辅助根治性膀胱切除术(RARC)与开放性根治性膀胱切除术(ORC)相比,在短期肿瘤学结果方面显示出非劣效性。RARC 中期和长期肿瘤学结果的数据有限。

目的

评估 MIBC 和高危非 MIBC(NMIBC)患者接受 ORC 与 RARC 治疗的中期总生存期(OS)和无复发生存期(RFS)。

方法和材料

这是一项在 19 家荷兰医院进行的全国性回顾性研究,纳入了 2012 年 1 月 1 日至 2015 年 12 月 31 日期间接受 ORC(n=1086)或 RARC(n=386)治疗的 MIBC 和高危 NMIBC 患者。主要和次要终点分别为中位 OS 和 RFS。生存结果通过 Kaplan-Meier 曲线进行估计。采用多变量 Cox 回归模型来调整可能的混杂因素,并评估包括临床变量、临床和病理疾病分期、新辅助治疗和手术切缘状态在内的生存预后因素。

结果

中位随访时间为 5.1 年(95%置信区间[95%CI]5.0-5.2)。ORC 后的中位 OS 为 5.0 年(95%CI 4.3-5.6),RARC 后的中位 OS 为 5.8 年(95%CI 5.1-6.5)。ORC 后的中位 RFS 为 3.8 年(95%CI 3.1-4.5),RARC 后的中位 RFS 为 5.0 年(95%CI 3.9-6.0)。多变量调整后,ORC 与 RARC 的 OS 风险比为 1.00(95%CI 0.84-1.20),RFS 风险比为 1.08(95%CI 0.91-1.27)。接受 ORC 治疗的患者年龄更大,术前血清肌酐水平更高,且临床和病理疾病分期更晚期。

结论

在近 1500 例 MIBC 和高危 NMIBC 患者队列中,ORC 和 RARC 导致了相似的中期 OS 和 RFS。

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