Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of
Adult
Afatinib
/ administration & dosage
Aged
Aged, 80 and over
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Carcinoma, Non-Small-Cell Lung
/ drug therapy
Cetuximab
/ administration & dosage
ErbB Receptors
/ genetics
Female
Humans
Lung Neoplasms
/ drug therapy
Male
Middle Aged
Mutation
Progression-Free Survival
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 12 2020
01 12 2020
Historique:
pubmed:
7
10
2020
medline:
7
4
2021
entrez:
6
10
2020
Statut:
ppublish
Résumé
The irreversible ErbB family tyrosine kinase inhibitor (TKI) afatinib plus the EGFR monoclonal antibody cetuximab was previously shown to overcome resistance to EGFR TKIs. We studied whether the combination of afatinib plus cetuximab compared with afatinib alone would improve progression-free survival (PFS) in patients with treatment-naive Patients with Between March 25, 2015 and April 23, 2018, 174 patients were randomly assigned, and 168 (83 on afatinib + cetuximab and 85 on afatinib) were eligible. There was no improvement in PFS in patients receiving afatinib plus cetuximab compared with afatinib alone (hazard ratio [HR], 1.01; 95% CI, 0.72 to 1.43; The addition of cetuximab to afatinib did not improve outcomes in previously untreated
Identifiants
pubmed: 33021871
doi: 10.1200/JCO.20.01149
pmc: PMC7768342
doi:
Substances chimiques
Afatinib
41UD74L59M
EGFR protein, human
EC 2.7.10.1
ErbB Receptors
EC 2.7.10.1
Cetuximab
PQX0D8J21J
Banques de données
ClinicalTrials.gov
['NCT02438722']
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
4076-4085Subventions
Organisme : NCI NIH HHS
ID : U10 CA180826
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA093373
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189971
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189873
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189821
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233230
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180835
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180798
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA239767
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189972
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233340
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180820
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189808
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189957
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180888
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180819
Pays : United States
Organisme : NCI NIH HHS
ID : P50 CA196530
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180821
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180801
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189872
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189822
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180846
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189858
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189860
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189830
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA189954
Pays : United States
Déclaration de conflit d'intérêts
The author(s) meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. Boehringer Ingelheim Pharmaceuticals (BIPI) had no role in the design, analysis or interpretation of the results in this study; BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as it relates to BIPI substances, as well as intellectual property considerations. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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