Neoadjuvant chemoimmunotherapy followed by radical cystectomy followed by adjuvant immunotherapy

A randomized controlled trial (NIAGARA [NCT03732677]) compared neoadjuvant durvalumab plus gemcitabine and cisplatin followed by radical cystectomy and adjuvant durvalumab (durvalumab arm) with neoadjuvant gemcitabine and cisplatin followed by radical cystectomy (comparison arm). The study included 1,063 patients with clinical stage T2 or higher muscle-invasive bladder cancer. Patients were eligible to receive cisplatin if they had a creatinine clearance of at least 40 mL/min. Four cycles of neoadjuvant durvalumab (1,500 mg) were given every 3 weeks, and up to eight cycles of adjuvant durvalumab (1,500 mg) were given every 4 weeks.[19][Level of evidence A1]

A randomized controlled trial (NIAGARA [NCT03732677]) compared neoadjuvant durvalumab plus gemcitabine and cisplatin followed by radical cystectomy and adjuvant durvalumab (durvalumab arm) with neoadjuvant gemcitabine and cisplatin followed by radical cystectomy (comparison arm). The study included 1,063 patients with clinical stage T2 or higher muscle-invasive bladder cancer. Patients were eligible to receive cisplatin if they had a creatinine clearance of at least 40 mL/min. Four cycles of neoadjuvant durvalumab (1,500 mg) were given every 3 weeks, and up to eight cycles of adjuvant durvalumab (1,500 mg) were given every 4 weeks.[19][Level of evidence A1]

At 24 months, the OS rate was 82.2% (95% confidence interval [CI], 78.7%–85.2%) in the durvalumab arm and 75.2% (95% CI, 71.3%–78.8%) in the comparison arm (hazard ratio [HR], 0.75; 95% CI, 0.59–0.93).

A randomized controlled trial (NIAGARA [NCT03732677]) compared neoadjuvant durvalumab plus gemcitabine and cisplatin followed by radical cystectomy and adjuvant durvalumab (durvalumab arm) with neoadjuvant gemcitabine and cisplatin followed by radical cystectomy (comparison arm). The study included 1,063 patients with clinical stage T2 or higher muscle-invasive bladder cancer. Patients were eligible to receive cisplatin if they had a creatinine clearance of at least 40 mL/min. Four cycles of neoadjuvant durvalumab (1,500 mg) were given every 3 weeks, and up to eight cycles of adjuvant durvalumab (1,500 mg) were given every 4 weeks.[19][Level of evidence A1]

At 24 months, the event-free survival (EFS) rate was 67.8% (95% CI, 63.6%–71.7%) in the durvalumab arm and 59.8% (95% CI, 55.4%–64.0%) in the comparison arm (HR, 0.68; 95% CI, 0.56–0.82).

A randomized controlled trial (NIAGARA [NCT03732677]) compared neoadjuvant durvalumab plus gemcitabine and cisplatin followed by radical cystectomy and adjuvant durvalumab (durvalumab arm) with neoadjuvant gemcitabine and cisplatin followed by radical cystectomy (comparison arm). The study included 1,063 patients with clinical stage T2 or higher muscle-invasive bladder cancer. Patients were eligible to receive cisplatin if they had a creatinine clearance of at least 40 mL/min. Four cycles of neoadjuvant durvalumab (1,500 mg) were given every 3 weeks, and up to eight cycles of adjuvant durvalumab (1,500 mg) were given every 4 weeks.[19][Level of evidence A1]

Grade 3 or higher treatment-related adverse events occurred in 40.6% of patients in the durvalumab arm and 40.9% of patients in the comparison arm.

A randomized controlled trial (NIAGARA [NCT03732677]) compared neoadjuvant durvalumab plus gemcitabine and cisplatin followed by radical cystectomy and adjuvant durvalumab (durvalumab arm) with neoadjuvant gemcitabine and cisplatin followed by radical cystectomy (comparison arm). The study included 1,063 patients with clinical stage T2 or higher muscle-invasive bladder cancer. Patients were eligible to receive cisplatin if they had a creatinine clearance of at least 40 mL/min. Four cycles of neoadjuvant durvalumab (1,500 mg) were given every 3 weeks, and up to eight cycles of adjuvant durvalumab (1,500 mg) were given every 4 weeks.[19][Level of evidence A1]

Radical cystectomy was performed in 88.0% of patients in the durvalumab arm and 83.2% of patients in the comparison arm.