Study findings support the safety of radical cystectomy and pelvic lymph node dissection (PLND) in patients with nonmetastatic bladder cancer who received neoadjuvant pembrolizumab (Eur Urol. 2020;77[5]:576-580).

“No data are available on the surgical safety of radical cystectomy…[and PLND]…after the administration of checkpoint inhibitors” explained Alberto Briganti, MD, Unit of Urology/Division of Oncology, URI, IRCCS Ospedale San Raffaele, Milan, Italy, and colleagues, who sought to evaluate perioperative outcomes following radical cystectomy and extended PLND in patients with muscle-invasive bladder cancer (MIBC) given neoadjuvant pembrolizumab therapy.

Between February 2017 and June 2019, a total of 68 patients given 3 courses of intravenous pembrolizumab 200 mg every 3 weeks before undergoing open or robot-assisted radical cystectomy and PLND were enrolled in the PURE-01 trial.

Intra- and post-operative outcomes data were prospectively collected for all patients, and the Clavien-Dindo system was used to grade postoperative complications. At 90 days post-surgery, peri-operative data were prospectively and systematically collected via patient interviews in accordance with European Association of Urology Guidelines Panel recommendations on reporting and grading complications.

A total of 52 (77%) patients had robot-assisted surgery, whereas 16 (23%) had open radical cystectomies; 31 (46%) patients received an orthotopic neobladder. Patients lost a median of 150 mL of blood and had a 12-day hospital stay.

Findings showed that 52 (77%) and 47 (69%) patients had any-grade complications and grade ≥2 complications, respectively. In addition, there were 22 (32%) patients readmitted at 90 days.

With regard to complications, 23 (34%) patients had high-grade complications (defined as Clavien-Dindo ≥3a). Fever and ileus were the most frequently reported complications, occurring in 35 (52%) and 21 (31%) patients, respectively.

There were no reports of perioperative mortality at 90 days.

“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,” Dr Briganti and colleagues concluded.—Hina Porcelli