New data support the safety of radical cystectomy and pelvic lymph node dissection (PLND) following neoadjuvant treatment with pembrolizumab for muscle-invasive bladder cancer (MIBC), according to investigators.
The data are from a prospective assessment of perioperative outcomes from the PURE-01 trial. A total of 68 consecutive patients with a median age of 67 years who received 3 courses of 200 mg pembrolizumab, a checkpoint inhibitor, every 3 weeks and subsequently underwent either open or robot-assisted radical cystectomy as well as PLND (52 and 16 patients, respectively). Thirty-one patients (46%) received an orthotopic neobladder.
Median blood loss and length of stay were 150 mL and 12 days, respectively, Alberto Briganti, MD, of San Raffaele Hospital in Milan, Italy, and colleagues reported in European Urology. A total of 52 patients (77%) experienced complications of any grade, whereas 47 (69%) and 22 (32%) experienced grade 2 or higher complications and readmission at 90 days, respectively.
High-grade complications (Clavien-Dindo 3a or higher) were observed in 23 patients (34%). The most frequent complications were fever and ileus, which occurred in 35 (52%) and 21 (31%) of patients, respectively. No patient died during the 90 days following surgery.
“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,” the authors wrote.
Briganti A, Gandaglia G, Scuderi S, et al. Surgical safety of radical cystectomy and pelvic lymph node dissection following neoadjuvant pembolizumab in patients with bladder cancer: Prospective assessment perioperative outcomes from the PURE-01 trial [published online January 3, 2020]. Eur Urol. doi: 10.1016/j.eururo.2019.12.019