Perioperative Nivolumab in Resectable Lung Cancer.
Humans
Nivolumab
/ therapeutic use
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Female
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Aged
Neoadjuvant Therapy
Double-Blind Method
Chemotherapy, Adjuvant
Progression-Free Survival
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Adult
Antineoplastic Agents, Immunological
/ therapeutic use
Neoplasm Staging
Immune Checkpoint Inhibitors
/ therapeutic use
Pneumonectomy
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
16 May 2024
16 May 2024
Historique:
medline:
15
5
2024
pubmed:
15
5
2024
entrez:
15
5
2024
Statut:
ppublish
Résumé
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. 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 according to blinded independent review, overall survival, and safety. At this prespecified interim analysis (median follow-up, 25.4 months), the percentage 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<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. 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.).
Sections du résumé
BACKGROUND
BACKGROUND
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
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 according to blinded independent review, overall survival, and safety.
RESULTS
RESULTS
At this prespecified interim analysis (median follow-up, 25.4 months), the percentage 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<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
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.).
Identifiants
pubmed: 38749033
doi: 10.1056/NEJMoa2311926
doi:
Banques de données
ClinicalTrials.gov
['NCT04025879']
Types de publication
Journal Article
Randomized Controlled Trial
Clinical Trial, Phase III
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
1756-1769Investigateurs
Lorena Lupinacci
(L)
Carmen Pupareli
(C)
Gonzalo Recondo
(G)
Karina Vera
(K)
Wasek Faisal
(W)
Melissa Morre
(M)
Maryam Bourhaba
(M)
Ingel Demedts
(I)
Annelies Janssens
(A)
Marcelo Corassa
(M)
Fabio Franke
(F)
Ludmila de Oliveira Muniz Koch
(L)
Nicole Monteiro
(N)
Ke-Neng Chen
(KN)
Shugeng Gao
(S)
Yang Gao
(Y)
Jie He
(J)
Gening Jiang
(G)
Lunxu Liu
(L)
Shun Lu
(S)
Lijie Tan
(L)
Wenxiang Wang
(W)
Lin Wu
(L)
Fei Xiong
(F)
Kejing Ying
(K)
Libor Havel
(L)
Lubos B Petruzelka
(LB)
Jacques Cadranel
(J)
Florian Guisier
(F)
Hervé Lena
(H)
Denis Moro-Sibilot
(D)
Jean-Louis Pujol
(JL)
Akin Atmaca
(A)
Alexander Baraniskin
(A)
Helge Bischoff
(H)
Sabine Bohnet
(S)
Eva Lotte Buchmeier
(EL)
Nikolaj Frost
(N)
Petra Hoffknecht
(P)
Kato Kambartel
(K)
Jonas Kuon
(J)
Christian Schumann
(C)
Matthias Ulmer
(M)
Angelo Delmonte
(A)
Erika Rijavec
(E)
Marcello Tiseo
(M)
Hidehito Horinouchi
(H)
Hiroyuki Ito
(H)
Hiroaki Kuroda
(H)
Satoshi Muto
(S)
Morihito Okada
(M)
Jiro Okami
(J)
Kyoichi Okishio
(K)
Yuki Sato
(Y)
Masahiro Seike
(M)
Shunichi Sugawara
(S)
Kazuya Takamochi
(K)
Yuichi Tambo
(Y)
Fumihiro Tanaka
(F)
Masahiro Tsuboi
(M)
Yasutaka Watanabe
(Y)
Rene Lazaro Gonzalez Mendoza
(RL)
Juan Carlos Vazquez Limon
(JC)
Omar Alejandro Zayas Villaneuva
(OA)
Robin Cornelissen
(R)
Jeroen Hiltermann
(J)
Jaroslaw Kuzdzal
(J)
Aurelia Alexandru
(A)
Tudor-Eliade Ciuleanu
(TE)
Andrei Ungureanu
(A)
Nina Karaseva
(N)
Fedor V Moiseyenko
(FV)
Maria Smagina
(M)
Oscar Juan Vidal
(OJ)
Mariano Provencio Pulla
(M)
Jose Miguel Sanchez Torres
(JM)
Kang-Yun Lee
(KY)
Jin-Yuan Shih
(JY)
Mark M Awad
(MM)
Christine M Bestvina
(CM)
Rodolfo Bordoni
(R)
Debora Bruno
(D)
Tina Cascone
(T)
Jhanelle Gray
(J)
Andrew Parchman
(A)
Jyoti Patel
(J)
Christopher Vaughn
(C)
Ezra Baraban
(E)
Alexander S Baras
(AS)
Ashley Cimino-Mathews
(A)
Julie Stein Deutsch
(JS)
Edward Gabrielson
(E)
Peter B Illei
(PB)
Jaroslaw Jedrych
(J)
Janis M Taube
(JM)
Elizabeth D Thompson
(ED)
Informations de copyright
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