Immunotherapy-based neoadjuvant treatment and complication rates after radical cystectomy.

Objective: To assess 30- and 90-day postoperative complication rates in patients who underwent robot-assisted radical cystectomy (RARC) after receiving novel immunotherapy-based neoadjuvant treatment.

Methods: A bi-centre analysis was conducted in patients who underwent RARC with intracorporeal urinary diversion and who received an immunotherapy-based neoadjuvant regimen between 2017 and 2023. Complications were classified using the Clavien-Dindo system.

Results: The cohort included 136 patients, with a median (interquartile range [IQR]) age of 66 (61-73) years, of whom 22 were female (16.2%). The overall 30-day and 31-90-day Clavien-Dindo grade ≥3a complication rates were 15.4%, and 14.7%, respectively. The most common cumulative 90-day complications by category were infectious (59.6%), genitourinary (33.1%), and gastrointestinal (22.7%). The median (IQR) hospital stay was 11 (7-16) days, and 36 patients (26.5%) required readmission. Eighty-four patients received monotherapy with an immune checkpoint inhibitor and 52 received combination immunochemotherapy. A higher rate of 30-day infectious complications was seen in the immuno-monotherapy group (46.4% vs 26.9%; P = 0.03), while pulmonary complications were more commonly reported in the combination immunochemotherapy group (9.6% vs 1.2%; P = 0.03). No statistically significant differences were found in the other complication categories between the groups. Eleven patients (8.1%) experienced 13 (9.6%) immune-related adverse events (irAEs). The most common irAEs were hypothyroidism and dermatitis.

Conclusions: The cumulative 90-day complication rate after novel immunotherapy-based neoadjuvant treatment appears higher than those previously reported for RARC alone or for chemotherapy-based neoadjuvant regimens. We observed irAEs in 8.1% of patients after RARC, highlighting the need for urologists to recognise such events.