Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer.
Humans
Adjuvants, Immunologic
/ therapeutic use
Administration, Intravenous
Antineoplastic Agents, Immunological
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
B7-H1 Antigen
/ administration & dosage
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Combined Modality Therapy
Lung Neoplasms
/ drug therapy
Neoplasm Recurrence, Local
/ drug therapy
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:
02 Nov 2023
02 Nov 2023
Historique:
medline:
3
11
2023
pubmed:
23
10
2023
entrez:
23
10
2023
Statut:
ppublish
Résumé
Neoadjuvant or adjuvant immunotherapy can improve outcomes in patients with resectable non-small-cell lung cancer (NSCLC). Perioperative regimens may combine benefits of both to improve long-term outcomes. We randomly assigned patients with resectable NSCLC (stage II to IIIB [N2 node stage] according to the eighth edition of the A total of 802 patients were randomly assigned to receive durvalumab (400 patients) or placebo (402 patients). The duration of event-free survival was significantly longer with durvalumab than with placebo; the stratified hazard ratio for disease progression, recurrence, or death was 0.68 (95% confidence interval [CI], 0.53 to 0.88; P = 0.004) at the first interim analysis. At the 12-month landmark analysis, event-free survival was observed in 73.4% of the patients who received durvalumab (95% CI, 67.9 to 78.1), as compared with 64.5% of the patients who received placebo (95% CI, 58.8 to 69.6). The incidence of pathological complete response was significantly greater with durvalumab than with placebo (17.2% vs. 4.3% at the final analysis; difference, 13.0 percentage points; 95% CI, 8.7 to 17.6; P<0.001 at interim analysis of data from 402 patients). Event-free survival and pathological complete response benefit were observed regardless of stage and PD-L1 expression. Adverse events of maximum grade 3 or 4 occurred in 42.4% of patients with durvalumab and in 43.2% with placebo. Data from 62 patients with documented In patients with resectable NSCLC, perioperative durvalumab plus neoadjuvant chemotherapy was associated with significantly greater event-free survival and pathological complete response than neoadjuvant chemotherapy alone, with a safety profile that was consistent with the individual agents. (Funded by AstraZeneca; AEGEAN ClinicalTrials.gov number, NCT03800134.).
Sections du résumé
BACKGROUND
BACKGROUND
Neoadjuvant or adjuvant immunotherapy can improve outcomes in patients with resectable non-small-cell lung cancer (NSCLC). Perioperative regimens may combine benefits of both to improve long-term outcomes.
METHODS
METHODS
We randomly assigned patients with resectable NSCLC (stage II to IIIB [N2 node stage] according to the eighth edition of the
RESULTS
RESULTS
A total of 802 patients were randomly assigned to receive durvalumab (400 patients) or placebo (402 patients). The duration of event-free survival was significantly longer with durvalumab than with placebo; the stratified hazard ratio for disease progression, recurrence, or death was 0.68 (95% confidence interval [CI], 0.53 to 0.88; P = 0.004) at the first interim analysis. At the 12-month landmark analysis, event-free survival was observed in 73.4% of the patients who received durvalumab (95% CI, 67.9 to 78.1), as compared with 64.5% of the patients who received placebo (95% CI, 58.8 to 69.6). The incidence of pathological complete response was significantly greater with durvalumab than with placebo (17.2% vs. 4.3% at the final analysis; difference, 13.0 percentage points; 95% CI, 8.7 to 17.6; P<0.001 at interim analysis of data from 402 patients). Event-free survival and pathological complete response benefit were observed regardless of stage and PD-L1 expression. Adverse events of maximum grade 3 or 4 occurred in 42.4% of patients with durvalumab and in 43.2% with placebo. Data from 62 patients with documented
CONCLUSIONS
CONCLUSIONS
In patients with resectable NSCLC, perioperative durvalumab plus neoadjuvant chemotherapy was associated with significantly greater event-free survival and pathological complete response than neoadjuvant chemotherapy alone, with a safety profile that was consistent with the individual agents. (Funded by AstraZeneca; AEGEAN ClinicalTrials.gov number, NCT03800134.).
Identifiants
pubmed: 37870974
doi: 10.1056/NEJMoa2304875
doi:
Substances chimiques
Adjuvants, Immunologic
0
Antineoplastic Agents, Immunological
0
B7-H1 Antigen
0
durvalumab
28X28X9OKV
Banques de données
ClinicalTrials.gov
['NCT03800134']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1672-1684Investigateurs
Gabriel Garbaos
(G)
Ruben Kowalyszyn
(R)
Susana Berutti
(S)
Susana Sena
(S)
Juan Cundom
(J)
Alejandro Salvatierra
(A)
Karina Vera
(K)
Susana Kahl
(S)
Sabine Zoechbauer-Mueller
(S)
Gudrun Absenger
(G)
Andreas Pircher
(A)
Thomas Winder
(T)
Arschang Valipour
(A)
Paul Germonpré
(P)
Stéphane Holbrechts
(S)
João Daniel Guedes
(JD)
Gustavo Junqueira
(G)
Ana Gelatti
(A)
Luis Antunes
(L)
Marcelo Felizola
(M)
Paulo Eduardo Pizão
(PE)
Sulene Cunha
(S)
Carlos Teixeira
(C)
Yeni Neron
(Y)
Leonardo Rodrigues
(L)
Glaucio Bertollo
(G)
Velko Minchev
(V)
Quincy Chu
(Q)
Mita Manna
(M)
Kevin Jao
(K)
Daniele Marceau
(D)
Jean-Luc Dionne
(JL)
Francisco Orlandi
(F)
Eugenia Loredo
(E)
Shugeng Gao
(S)
Jie He
(J)
Chang Chen
(C)
Hongbing Duan
(H)
Hongxu Liu
(H)
Gaofeng Li
(G)
Mei Xinyu
(M)
Zhidong Liu
(Z)
Wenxiang Wang
(W)
Qixun Chen
(Q)
Lunxu Liu
(L)
Ming Wu
(M)
Jie Bai
(J)
Waresijiang Yibulayin
(W)
Chenwei Li
(C)
Qing Geng
(Q)
Wentao Fang
(W)
Minhua Ye
(M)
Yufeng Ba
(Y)
Yi Ren
(Y)
Jian You
(J)
Yonghui Di
(Y)
Sheng Wang
(S)
Lin Yang
(L)
Jixian Liu
(J)
Ming Zhou
(M)
Qianyun Wang
(Q)
Chaoyang Liang
(C)
Luis Corrales Rodriguez
(L)
Adríán Gúzman Ramírez
(A)
Olivier Bylicki
(O)
Nicolas Cloarec
(N)
Benoît Godbert
(B)
Josiane Otto
(J)
Florian Weissinger
(F)
Eva Lotte Buchmeier
(EL)
Christian Schumann
(C)
Silvan Becker
(S)
Gyula Ostoros
(G)
Zsolt Pápai Székely
(Z)
Gabriella Gálffy
(G)
László Urbán
(L)
Zsuzsanna Szalai
(Z)
Vineet Gupta
(V)
Praveena Voonna
(P)
Ullas Batra
(U)
Shruti Kate
(S)
Bivas Biswas
(B)
Ahish Kaushal
(A)
Sewanti Limaye
(S)
Deepan Rajamanickam
(D)
Dipanjan Panda
(D)
Srinivas K G
(S)
Giulia Pasello
(G)
Michele Milella
(M)
Domenico Galetta
(D)
Emilio Bria
(E)
Diego Cortinovis
(D)
Alessandra Bulotta
(A)
Anna Bettini
(A)
Lorenzo Antonuzzo
(L)
Yasutaka Watanabe
(Y)
Hiroshi Tanaka
(H)
Hiroaki Kuroda
(H)
Tetsuji Kawamura
(T)
Yuichi Ozawa
(Y)
Shinichi Toyooka
(S)
Masao Nakata
(M)
Shoichi Kuyama
(S)
Hidekazu Suzuki
(H)
Fumihiro Tanaka
(F)
Junichi Soh
(J)
Morihito Okada
(M)
Yasuo Iwamoto
(Y)
Jeronimo Rodriguez Cid
(J)
Oscar Arrieta Rodriguez
(O)
Froylan López-López
(F)
Cesar Gozález de León
(C)
Emmanuel Peña Gómez Portugal
(E)
Emmanuel de la Mora Jiménez
(E)
Yamil López Chuken
(Y)
Niels Claessens
(N)
Atilio Romero
(A)
Natalia Valdiviezo
(N)
Arthur Gregory Lui
(AG)
Jarosław Kołb-Sielecki
(J)
Renata Duchnowska
(R)
Dariusz Kowalski
(D)
Robert Mróz
(R)
Doina Ganea
(D)
Lyubov Vladimirova
(L)
Ruslan Zukov
(R)
Alexey Smolin
(A)
Sergei Dvoretskiy
(S)
Guzel Mukhametshina
(G)
Liudmila Lenskaya
(L)
Vitaliy Skoropad
(V)
Nikolay Kislov
(N)
Marina Matrosova
(M)
Maria Kazantseva
(M)
Sang-We Kim
(SW)
Jong Seok Lee
(JS)
Ki Hyeong Lee
(KH)
Sung Sook Lee
(SS)
Jin-Hyoung Kang
(JH)
Byoung Yong Shim
(BY)
Manuel Cobo Dols
(M)
Luis León Mateos
(LL)
Emilio Esteban Gonzalez
(EE)
Ignacio Gil
(I)
Alfredo Paredes Lario
(A)
Manuel Domine Gomez
(M)
Noemi Reguart Aransay
(N)
Bartomeu Massuti Sureda
(B)
Kang-Yun Lee
(KY)
Tsung-Ying Yang
(TY)
Ming-Fang Wu
(MF)
Chien-Chung Lin
(CC)
Chong-Jen Yu
(CJ)
Han-Pin Kuo
(HP)
Chao-Hsun Chen
(CH)
Sheng-Hao Lin
(SH)
Somcharoen Saeteng
(S)
Yotsawaj Runglodvatana
(Y)
Aumkhae Sookprasert
(A)
Piyada Sitthideatphaiboon
(P)
Nilubol Raunroadroong
(N)
Mary Fidler
(M)
Panayiotis Savvides
(P)
Anirudha Dasgupta
(A)
Jae Kim
(J)
Bryan Steinberg
(B)
John Wrangle
(J)
Jeffrey Crawford
(J)
William Martin
(W)
Shaker Dakhil
(S)
Homam Alkaied
(H)
Mehdi Moezi
(M)
Ali Amjad
(A)
Firas Badin
(F)
Daniel Moore
(D)
John V Heymach
(JV)
Jamie Chaft
(J)
George Geils
(G)
Timothy Larson
(T)
James Uyeki
(J)
Alexander Spira
(A)
Tran V Tho
(TV)
Dinh Van Luong
(DV)
Le T Ha
(LT)
Huu-Vinh Vu
(HV)
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