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Durvalumab after Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer

Authors
 S.J. Antonia  ;  A. Villegas  ;  D. Daniel  ;  D. Vicente  ;  S. Murakami  ;  R. Hui  ;  T. Yokoi  ;  A. Chiappori  ;  K.H. Lee  ;  M. de Wit  ;  B.C. Cho, M. Bourhaba  ;  X. Quantin  ;  T. Tokito  ;  T. Mekhail  ;  D. Planchard  ;  Y.-C. Kim  ;  C.S. Karapetis  ;  S. Hiret  ;  G. Ostoros  ;  K. Kubota  ;  J.E. Gray  ;  L. Paz‑Ares  ;  J. de Castro Carpeño  ;  C. Wadsworth  ;  G. Melillo  ;  H. Jiang  ;  Y. Huang  ;  P.A. Dennis  ;  M. Özgüroğlu 
Citation
 NEW ENGLAND JOURNAL OF MEDICINE, Vol.377(20) : 1919-1929, 2017 
Journal Title
NEW ENGLAND JOURNAL OF MEDICINE
ISSN
 0028-4793 
Issue Date
2017
MeSH
Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal/therapeutic use ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/therapeutic use ; B7-H1 Antigen/antagonists & inhibitors ; Carcinoma, Non-Small-Cell Lung/mortality ; Carcinoma, Non-Small-Cell Lung/secondary ; Carcinoma, Non-Small-Cell Lung/therapy ; Chemoradiotherapy ; Disease-Free Survival ; Female ; Humans ; Intention to Treat Analysis ; Kaplan-Meier Estimate ; Lung Neoplasms/mortality ; Lung Neoplasms/pathology ; Lung Neoplasms/therapy ; Male ; Middle Aged ; Neoplasm Staging
Abstract
BACKGROUND:

Most patients with locally advanced, unresectable, non-small-cell lung cancer (NSCLC) have disease progression despite definitive chemoradiotherapy (chemotherapy plus concurrent radiation therapy). This phase 3 study compared the anti-programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy.

METHODS:

We randomly assigned patients, in a 2:1 ratio, to receive durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) or placebo every 2 weeks for up to 12 months. The study drug was administered 1 to 42 days after the patients had received chemoradiotherapy. The coprimary end points were progression-free survival (as assessed by means of blinded independent central review) and overall survival (unplanned for the interim analysis). Secondary end points included 12-month and 18-month progression-free survival rates, the objective response rate, the duration of response, the time to death or distant metastasis, and safety.

RESULTS:

Of 713 patients who underwent randomization, 709 received consolidation therapy (473 received durvalumab and 236 received placebo). The median progression-free survival from randomization was 16.8 months (95% confidence interval [CI], 13.0 to 18.1) with durvalumab versus 5.6 months (95% CI, 4.6 to 7.8) with placebo (stratified hazard ratio for disease progression or death, 0.52; 95% CI, 0.42 to 0.65; P<0.001); the 12-month progression-free survival rate was 55.9% versus 35.3%, and the 18-month progression-free survival rate was 44.2% versus 27.0%. The response rate was higher with durvalumab than with placebo (28.4% vs. 16.0%; P<0.001), and the median duration of response was longer (72.8% vs. 46.8% of the patients had an ongoing response at 18 months). The median time to death or distant metastasis was longer with durvalumab than with placebo (23.2 months vs. 14.6 months; P<0.001). Grade 3 or 4 adverse events occurred in 29.9% of the patients who received durvalumab and 26.1% of those who received placebo; the most common adverse event of grade 3 or 4 was pneumonia (4.4% and 3.8%, respectively). A total of 15.4% of patients in the durvalumab group and 9.8% of those in the placebo group discontinued the study drug because of adverse events.

CONCLUSIONS:

Progression-free survival was significantly longer with durvalumab than with placebo. The secondary end points also favored durvalumab, and safety was similar between the groups. (Funded by AstraZeneca; PACIFIC ClinicalTrials.gov number, NCT02125461 .).
DOI
10.1056/NEJMoa1709937
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Cho, Byoung Chul(조병철) ORCID logo https://orcid.org/0000-0002-5562-270X
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/161556
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