Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F24%3A10001342" target="_blank" >RIV/00064190:_____/24:10001342 - isvavai.cz</a>

Result on the web

<a href="https://doi.org/10.1056/NEJMoa2408154" target="_blank" >https://doi.org/10.1056/NEJMoa2408154</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1056/NEJMoa2408154" target="_blank" >10.1056/NEJMoa2408154</a>

Result language

angličtina

Original language name

Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer

Original language description

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, cisplatin-eligible 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&lt;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. Copyright (C) 2024 Massachusetts Medical Society.

Czech name

—

Czech description

—

Type

J_SC - Article in a specialist periodical, which is included in the SCOPUS database

CEP classification

—

OECD FORD branch

30204 - Oncology

Project

—

Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2024

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

NEW ENGLAND JOURNAL OF MEDICINE

ISSN

0028-4793

e-ISSN

—

Volume of the periodical

391

Issue of the periodical within the volume

19

Country of publishing house

US - UNITED STATES

Number of pages

14

Pages from-to

1773-1786

UT code for WoS article

—

EID of the result in the Scopus database

2-s2.0-85207709532