No data are available on the surgical safety of radical cystectomy (RC) and pelvic lymph node dissection (PLND) after the administration of checkpoint inhibitors. We aimed at reporting the first prospective rigorous assessment of perioperative outcomes after RC and extended PLND following neoadjuvant pembrolizumab in a contemporary cohort of patients with muscle-invasive bladder cancer (MIBC) enrolled in the PURE-01 trial. From February 2017 to June 2019, a total of 68 consecutive patients who received three courses of 200 mg pembrolizumab intravenously every 3 wk and were subsequently treated with either open or robot-assisted RC and PLND at a single high-volume tertiary referral center were identified. All men had prospectively collected data about intra- and postoperative outcomes. Postoperative complications were graded according to the Clavien-Dindo system. Perioperative data were prospectively and systematically collected during patient interviews at 90 d after surgery according to the European Association of Urology (EAU) Guidelines Panel recommendations on reporting and grading complications. Overall, 52 (77%) versus 16 (23%) patients underwent robot-assisted versus open RC, and 31 patients (46%) received an orthotopic neobladder. Median blood loss and length of stay were 150 ml and 12 d, respectively. Overall, 52 (77%), 47 (69%), and 22 (32%) patients experienced any-grade complications, grade ≥2 complications, and readmission at 90 d, respectively. High-grade complications (defined as Clavien-Dindo ≥3a) were observed in 23 patients (34%). The most frequent complications were fever (n = 35, 52%) and ileus (n = 21, 31%). None of the patients experienced perioperative mortality at 90 d. Our data represent the first prospective evidence supporting the surgical safety of RC and PLND in patients with N0M0 MIBC who received neoadjuvant immunotherapy with pembrolizumab. PATIENT SUMMARY: The current study represents the first prospective evidence supporting the surgical safety of radical cystectomy and pelvic lymph node dissection in patients with nonmetastatic bladder cancer who received neoadjuvant immunotherapy with pembrolizumab.

中文翻译：

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新辅助性派姆单抗治疗膀胱癌后行根治性膀胱切除术和盆腔淋巴结清扫术的手术安全性：PURE-01试验围手术期结果的前瞻性评估。

在使用检查点抑制剂后，尚无关于根治性膀胱切除术（RC）和盆腔淋巴结清扫术（PLND）的手术安全性的数据。我们的目标是报告在PURE-01试验中纳入的当代一组肌肉浸润性膀胱癌（MIBC）患者的新辅助性派姆单抗治疗后RC和扩展PLND后的围手术期结局的首次前瞻性严格评估。从2017年2月到2019年6月，总共确定了68名连续患者，每3周接受3疗程的200 mg pembrolizumab静脉注射，随后在一个大容量的三级转诊中心接受开放式或机器人辅助RC和PLND的治疗。所有男性均前瞻性收集了有关术中和术后结果的数据。术后并发症根据Clavien-Dindo系统分级。根据欧洲泌尿外科协会（EAU）指南小组关于报告和分级并发症的建议，在手术后90 d的患者访谈中前瞻性和系统地收集围手术期数据。总体而言，分别有52例（77％）和16例（23％）的患者接受了机器人辅助或开放式RC，并且31例（46％）的患者接受了原位新膀胱。中位数失血量和住院时间分别为150 ml和12 d。总体而言，分别有52（77％），47（69％）和22（32％）的患者经历了任何等级的并发症，≥2级的并发症和90 d时再次入院。23例患者（34％）观察到严重并发症（定义为Clavien-Dindo≥3a）。最常见的并发症是发烧（n = 35，52％）和肠梗阻（n = 21，31％）。没有患者在90 d时发生围手术期死亡。我们的数据代表了接受pembrolizumab新辅助免疫治疗的N0M0 MIBC患者的RC和PLND手术安全性的首个前瞻性证据。病人总结：本研究代表了第一项前瞻性证据，支持接受培贝珠单抗新辅助免疫治疗的非转移性膀胱癌患者行根治性膀胱切除术和盆腔淋巴结清扫术的安全性。