Perioperative Durvalumab Improved Survival Outcomes for Patients With Operable, Muscle-Invasive Bladder Cancer
According to results from the phase 3 NIAGARA trial, the addition of perioperative durvalumab to neoadjuvant chemotherapy showed a significant improvement of event-free survival (EFS) and overall survival (OS) among cisplatin-eligible patients with operable, muscle-invasive bladder cancer.
The current standard of care for patients in this population is neoadjuvant chemotherapy, followed by radical cystectomy. As the Thomas Powles, MD, Barts Cancer Institute, London, United Kingdom, and coauthors, noted, “Adding perioperative immunotherapy may improve outcomes.” In this open-label trial, 1063 patients were enrolled and randomized on a 1-to-1 basis to receive either neoadjuvant durvalumab plus gemcitabine and cisplatin every 3 weeks for 4 cycles, followed by radical cystectomy and adjuvant durvalumab every 4 weeks for 8 cycles (n = 533), or neoadjuvant gemcitabine-cisplatin followed by radical cystectomy alone (n = 530). One of primary end points was EFS and the key secondary end point was OS.
The estimated 24-month EFS was 67.8% in the durvalumab arm vs 59.8% in the comparison arm (hazard ratio [HR] for progression, recurrence, not undergoing radical cystectomy, or death from any cause, 0.68; 95% confidence interval [CI], 0.56 to 0.82; P < .001). The estimated 24-month OS was 82.2% in the durvalumab arm vs 75.2% in the comparison arm (HR for death, 0.75; 95% CI, 0.59 to 0.93; P = .01). There were 40.6% of patients in the durvalumab arm who experienced a grade 3/4 treatment-related adverse event, vs 40.9% in the comparison arm.
Dr Powles, et al, concluded, “Perioperative durvalumab plus neoadjuvant chemotherapy led to significant improvements in event-free survival and overall survival as compared with neoadjuvant chemotherapy alone.”
Source:
Powles T, Catto JWF, Galsky MD, et al. Perioperative durvalumab with neoadjuvant chemotherapy in operable bladder cancer. N Engl J Med. Published Online: September 15, 2024. doi:10.1056/NEJMoa2408154
