Overall Survival and Biomarker Analysis of Neoadjuvant Nivolumab Plus Chemotherapy in Operable Stage IIIA Non-Small-Cell Lung Cancer (NADIM phase II trial).
Journal
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN: 1527-7755
Titre abrégé: J Clin Oncol
Pays: United States
ID NLM: 8309333
Informations de publication
Date de publication:
01 09 2022
01 09 2022
Historique:
pubmed:
17
5
2022
medline:
1
9
2022
entrez:
16
5
2022
Statut:
ppublish
Résumé
Neoadjuvant chemotherapy plus nivolumab has been shown to be effective in resectable non-small-cell lung cancer (NSCLC) in the NADIM trial (ClinicalTrials.gov identifier: NCT03081689). The 3-year overall survival (OS) and circulating tumor DNA (ctDNA) analysis have not been reported. This was an open-label, multicenter, single-arm, phase II trial in which patients with stage IIIA NSCLC, who were deemed to be surgically resectable, were treated with neoadjuvant paclitaxel (200 mg/m OS at 36 months was 81.9% (95% CI, 66.8 to 90.6) in the intention-to-treat population, rising to 91.0% (95% CI, 74.2 to 97.0) in the per-protocol population. Neither tumor mutation burden nor programmed cell death ligand-1 staining was predictive of survival. Conversely, low pretreatment levels of ctDNA were significantly associated with improved progression-free survival and OS (hazard ratio [HR], 0.20; 95% CI, 0.06 to 0.63, and HR, 0.07; 95% CI, 0.01 to 0.39, respectively). Clinical responses according to RECIST v1.1 criteria did not predict survival outcomes. However, undetectable ctDNA levels after neoadjuvant treatment were significantly associated with progression-free survival and OS (HR, 0.26; 95% CI, 0.07 to 0.93, and HR, 0.04; 95% CI, 0.00 to 0.55, respectively). The C-index to predict OS for ctDNA levels after neoadjuvant treatment (0.82) was superior to that of RECIST criteria (0.72). The efficacy of neoadjuvant chemotherapy plus nivolumab in resectable NSCLC is supported by 3-year OS. ctDNA levels were significantly associated with OS and outperformed radiologic assessments in the prediction of survival.
Identifiants
pubmed: 35576508
doi: 10.1200/JCO.21.02660
pmc: PMC9426809
doi:
Substances chimiques
Biomarkers
0
Nivolumab
31YO63LBSN
Banques de données
ClinicalTrials.gov
['NCT03081689']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2924-2933Commentaires et corrections
Type : ErratumIn
Références
NPJ Precis Oncol. 2020 Dec 1;4(1):32
pubmed: 33299121
N Engl J Med. 2015 Nov 5;373(19):1803-13
pubmed: 26406148
Lancet. 2016 Apr 9;387(10027):1540-1550
pubmed: 26712084
JAMA. 1982 May 14;247(18):2543-6
pubmed: 7069920
Int J Epidemiol. 2018 Jun 1;47(3):850-859
pubmed: 29444326
Oncoimmunology. 2018 Jan 29;7(5):e1424675
pubmed: 29721388
J Thorac Oncol. 2018 Dec;13(12):1818-1831
pubmed: 30268698
CA Cancer J Clin. 2021 Jan;71(1):7-33
pubmed: 33433946
N Engl J Med. 2015 Oct 22;373(17):1627-39
pubmed: 26412456
Nat Med. 2021 Feb;27(2):301-309
pubmed: 33558722
Br J Cancer. 2003 Jul 21;89(2):232-8
pubmed: 12865907
J Thorac Oncol. 2019 Mar;14(3):482-493
pubmed: 30503889
Clin Cancer Res. 2020 Apr 15;26(8):1924-1931
pubmed: 31852833
Lancet Oncol. 2013 Jun;14(7):619-26
pubmed: 23680111
Medicine (Baltimore). 2015 Jun;94(23):e879
pubmed: 26061306
J Clin Oncol. 2008 Aug 20;26(24):3913-5
pubmed: 18711176
J Clin Oncol. 2021 Sep 10;39(26):2872-2880
pubmed: 34251873
Lancet Oncol. 2021 Feb;22(2):198-211
pubmed: 33476593
Biom J. 2015 Jul;57(4):592-613
pubmed: 25530064
Eur J Cancer. 2021 May;149:61-72
pubmed: 33831609
Lung Cancer. 2021 Mar;153:25-34
pubmed: 33453470
Clin Transl Med. 2021 Jul;11(7):e491
pubmed: 34323406
N Engl J Med. 2016 Nov 10;375(19):1823-1833
pubmed: 27718847
Lancet Oncol. 2014 Jan;15(1):e42-50
pubmed: 24384493
Lancet Oncol. 2020 Nov;21(11):1413-1422
pubmed: 32979984
Lancet. 2014 May 3;383(9928):1561-71
pubmed: 24576776
Clin Cancer Res. 2021 Nov 1;27(21):5878-5890
pubmed: 34376534
Ann Oncol. 2018 Feb 1;29(2):311-323
pubmed: 29216340
N Engl J Med. 2018 May 31;378(22):2093-2104
pubmed: 29658845
Lancet Oncol. 2021 Apr;22(4):525-537
pubmed: 33721560
J Clin Oncol. 2020 May 10;38(14):1505-1517
pubmed: 32150489
Clin Cancer Res. 2020 Feb 1;26(3):545-551
pubmed: 31672770
Ann Oncol. 2018 Aug 1;29(8):1853-1860
pubmed: 29982279
Chest. 2013 May;143(5 Suppl):e314S-e340S
pubmed: 23649445
Cancer Res. 2019 Mar 15;79(6):1214-1225
pubmed: 30541742
Lung Cancer. 2021 Jul;157:109-115
pubmed: 34016490
N Engl J Med. 2015 Jul 9;373(2):123-35
pubmed: 26028407