Perioperative Nivolumab in Resectable Lung Cancer

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F24%3A10001251" target="_blank" >RIV/00064190:_____/24:10001251 - isvavai.cz</a>

Result on the web

<a href="https://doi.org/10.1056/NEJMoa2311926" target="_blank" >https://doi.org/10.1056/NEJMoa2311926</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1056/NEJMoa2311926" target="_blank" >10.1056/NEJMoa2311926</a>

Result language

angličtina

Original language name

Perioperative Nivolumab in Resectable Lung Cancer

Original language description

Standard treatment with neoadjuvant nivolumab plus chemotherapy significantly improves outcomes in patients with resectable non-small-cell lung cancer (NSCLC). Perioperative treatment (i.e., neoadjuvant therapy followed by surgery and adjuvant therapy) with nivolumab may further improve clinical outcomes. METHODS In this phase 3, randomized, double-blind trial, we assigned adults with resectable stage IIA to IIIB NSCLC to receive neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for 4 cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary outcome was event-free survival according to blinded independent review. Secondary outcomes were pathological complete response and major pathological response ac¬cording to blinded independent review, overall survival, and safety. RESULTS At this prespecified interim analysis (median follow-up, 25.4 months), the percent¬age of patients with 18-month event-free survival was 70.2% in the nivolumab group and 50.0% in the chemotherapy group (hazard ratio for disease progression or recurrence, abandoned surgery, or death, 0.58; 97.36% confidence interval [CI], 0.42 to 0.81; P&lt;0.001). A pathological complete response occurred in 25.3% of the patients in the nivolumab group and in 4.7% of those in the chemotherapy group (odds ratio, 6.64; 95% CI, 3.40 to 12.97); a major pathological response occurred in 35.4% and 12.1%, respectively (odds ratio, 4.01; 95% CI, 2.48 to 6.49). Grade 3 or 4 treatment-related adverse events occurred in 32.5% of the patients in the nivolumab group and in 25.2% of those in the chemotherapy group. CONCLUSIONS Perioperative treatment with nivolumab resulted in significantly longer event-free survival than chemotherapy in patients with resectable NSCLC. No new safety signals were observed. (Funded by Bristol Myers Squibb; CheckMate 77T ClinicalTrials.gov number, NCT04025879.). © 2024 Massachussetts Medical Society. All rights reserved.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30203 - Respiratory systems

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

1533-4406

Volume of the periodical

390

Issue of the periodical within the volume

19

Country of publishing house

US - UNITED STATES

Number of pages

14

Pages from-to

1756-1769

UT code for WoS article

001320338200009

EID of the result in the Scopus database

2-s2.0-85193375009