Randomized Trial of Afatinib Plus Cetuximab Versus Afatinib Alone for First-Line Treatment of


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
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

4076-4085

Subventions

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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Auteurs

Sarah B Goldberg (SB)

Yale School of Medicine, New Haven, CT.

Mary W Redman (MW)

SWOG Statistical Center, Seattle, WA.

Rogerio Lilenbaum (R)

Yale School of Medicine, New Haven, CT.

Katerina Politi (K)

Yale School of Medicine, New Haven, CT.

Thomas E Stinchcombe (TE)

Duke Cancer Center, Durham, NC.

Leora Horn (L)

Vanderbilt-Ingram Cancer Center, Nashville, TN.

Everett H Chen (EH)

Kaiser Permanente Medical Group/NCORP, Bellflower CA.

Sandeep H Mashru (SH)

Kaiser Permanente Medical Group/NCORP, Portland, OR.

Scott N Gettinger (SN)

Yale School of Medicine, New Haven, CT.

Mary Ann Melnick (MA)

Yale School of Medicine, New Haven, CT.

Roy S Herbst (RS)

Yale School of Medicine, New Haven, CT.

Megan A Baumgart (MA)

University of Rochester Medical Center, Rochester, NY.

Jieling Miao (J)

SWOG Statistical Center, Seattle, WA.

James Moon (J)

SWOG Statistical Center, Seattle, WA.

Karen Kelly (K)

UC Davis Comprehensive Cancer Center, Sacramento, CA.

David R Gandara (DR)

UC Davis Comprehensive Cancer Center, Sacramento, CA.

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Classifications MeSH