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Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer
Journal article   Peer reviewed

Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer

Toan Quang Vu, Lorenzo Antonuzzo, Pawel Wiechno, Vagif Atduev, Ariel G. Kann, Tae-Hwan Kim, Cristina Suarez, Chao-Hsiang Chang, Florian Roghmann, Mustafa Ozguroglu, …
The New England journal of medicine, Vol.391(19), pp.1773-1786
09/15/2024
DOI: 10.1056/NEJMoa2408154
PMID: 39282910
url
https://www.nejm.org/doi/10.1056/NEJMoa2408154?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pubView
Open Access

Abstract

BACKGROUND Neoadjuvant chemotherapy followed by radical cystectomy is the standard treatment for cisplatin-eligible patients with muscle-invasive bladder cancer. Adding perioperative immunotherapy may improve outcomes. METHODS In this phase 3, open-label, randomized trial, we assigned, in a 1:1 ratio, cisplatineligible patients with muscle-invasive bladder cancer to receive neoadjuvant durvalumab plus gemcitabine-cisplatin every 3 weeks for four cycles, followed by radical cystectomy and adjuvant durvalumab every 4 weeks for eight cycles (durvalumab group), or to receive neoadjuvant gemcitabine-cisplatin followed by radical cystectomy alone (comparison group). Event-free survival was one of two primary end points. Overall survival was the key secondary end point. RESULTS In total, 533 patients were assigned to the durvalumab group and 530 to the comparison group. The estimated event-free survival at 24 months was 67.8% (95% confidence interval [CI], 63.6 to 71.7) in the durvalumab group and 59.8% (95% CI, 55.4 to 64.0) in the comparison group (hazard ratio for progression, recurrence, not undergoing radical cystectomy, or death from any cause, 0.68; 95% CI, 0.56 to 0.82; P<0.001 by stratified log-rank test). The estimated overall survival at 24 months was 82.2% (95% CI, 78.7 to 85.2) in the durvalumab group and 75.2% (95% CI, 71.3 to 78.8) in the comparison group (hazard ratio for death, 0.75; 95% CI, 0.59 to 0.93; P = 0.01 by stratified log-rank test). Treatment-related adverse events of grade 3 or 4 in severity occurred in 40.6% of the patients in the durvalumab group and in 40.9% of those in the comparison group; treatment-related adverse events leading to death occurred in 0.6% in each group. Radical cystectomy was performed in 88.0% of the patients in the durvalumab group and in 83.2% of those in the comparison group. CONCLUSIONS Perioperative durvalumab plus neoadjuvant chemotherapy led to significant improvements in event-free survival and overall survival as compared with neoadjuvant chemotherapy alone.
 General & Internal Medicine Life Sciences & Biomedicine Medicine, General & Internal Science & Technology

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