Safety and quality of cystectomy and pelvic lymph node dissection after neoadjuvant durvalumab and cisplatin/gemcitabine

Abstract

ObjectiveTo report on the surgical safety and quality of pelvic lymph node dissection (PLND) in patients treated with radical cystectomy (RC) and PLND for muscle‐invasive bladder cancer (MIBC) after neoadjuvant chemo‐immunotherapy.Patients and MethodsThe Swiss Group for Clinical Cancer Research (SAKK) 06/17 was an open‐label single‐arm phase II trial including 61 cisplatin‐fit patients with clinical stage (c)T2–T4a cN0–1 operable urothelial MIBC or upper urinary tract cancer. Patients received neoadjuvant cisplatin/gemcitabine and durvalumab followed by surgery. Prospective quality assessment of surgeries was performed via central review of intraoperative photographs. Postoperative complications were assessed using the Clavien–Dindo Classification. Data were analysed descriptively.ResultsA total of 50 patients received RC and PLND. All patients received neoadjuvant chemo‐immunotherapy. The median (interquartile range) number of lymph nodes removed was 29 (23–38). No intraoperative complications were registered. Grade ≥III postoperative complications were reported in 12 patients (24%). Complete nodal dissection (100%) was performed at the level of the obturator fossa (bilaterally) and of the left external iliac region; in 49 patients (98%) at the internal iliac region and at the right external iliac region; in 39 (78%) and 38 (76%) patients at the right and left presacral level, respectively.ConclusionThis study supports the surgical safety of RC and PLND following neoadjuvant chemo‐immunotherapy in patients with MIBC. The extent and completeness of protocol‐defined PLND varies between patients, highlighting the need to communicate and monitor the surgical template.