Title :

First-line afatinib plus cetuximab for EGFR-mutant non–small cell lung cancer: Results from the randomized phase II IFCT-1503 ACE-lung study

Author(s) :

Cortot, Alexis Benjamin [Auteur correspondant]
Cancer Heterogeneity, Plasticity and Resistance to Therapies - UMR 9020 - U 1277 [CANTHER]
Madroszyk, Anne Catherine [Auteur]
Institut Paoli-Calmettes
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Giroux-Leprieur, Étienne [Auteur]
Hôpital Ambroise Paré [AP-HP]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Biomarqueurs et essais cliniques en Cancérologie et Onco-Hématologie [BECCOH]
Molinier, Olivier [Auteur]
Centre Hospitalier Le Mans (CH Le Mans)
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Quoix, Élisabeth A. [Auteur]
CHU Strasbourg
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Berard, Henri [Auteur]
Hopital d'instruction des armées Sainte-Anne [Toulon] [HIA]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Otto, Josiane [Auteur]
Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] [UNICANCER/CAL]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Rault, Isabelle [Auteur]
CHU Amiens-Picardie
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Moro-Sibilot, Denis L. [Auteur]
Institut d'oncologie/développement Albert Bonniot de Grenoble [INSERM U823]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Raimbourg, Judith [Auteur]
CRLCC René Gauducheau
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Amour, Elodie [Auteur]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Morin, Franck [Auteur]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Hureaux, José [Auteur]
Centre Hospitalier Universitaire d'Angers [CHU Angers]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Moreau, Lionel [Auteur]
Hôpitaux Civils de Colmar
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Debieuvre, Didier [Auteur]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Morel, Hugues [Auteur]
Centre Hospitalier Régional d'Orléans [CHRO]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Renault, Aldo [Auteur]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Pichon, Éric [Auteur]
Centre Hospitalier Régional Universitaire de Tours [CHRU Tours]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Huret, Benjamin [Auteur]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Charpentier, Sandrine [Auteur]
Centre hospitalier universitaire de Nantes [CHU Nantes]
Denis, M. G. [Auteur]
Centre hospitalier universitaire de Nantes [CHU Nantes]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]
Cadranel, Jacques L. [Auteur]
CHU Tenon [AP-HP]
Intergroupe Francophone de Cancérologie Thoracique [Paris] [IFCT]

Journal title :

Clinical Cancer Research

Pages :

4168-4176

Publisher :

American Association for Cancer Research

Publication date :

2021

ISSN :

1078-0432

HAL domain(s) :

Sciences du Vivant [q-bio]/Cancer

English abstract : [en]

Purpose: Double inhibition of epidermal growth factor receptor (EGFR) using a tyrosine kinase inhibitor plus a monoclonal antibody may be a novel treatment strategy for non–small cell lung cancer (NSCLC). We assessed the ...
Show more >Purpose: Double inhibition of epidermal growth factor receptor (EGFR) using a tyrosine kinase inhibitor plus a monoclonal antibody may be a novel treatment strategy for non–small cell lung cancer (NSCLC). We assessed the efficacy and toxicity of afatinib þ cetuximab versus afatinib alone in the first-line treatment of advanced EGFR-mutant NSCLC. Patients and Methods: In this phase II, randomized, open-label study, patients with stage III/IV EGFR-positive NSCLC were randomly assigned (1:1) to receive afatinib (group A) or afatinib þ cetuximab (group A þ C). Oral afatinib 40 mg was given once daily; cetuximab 250 mg/m2 was administered intravenously on day 15 of cycle 1, then every 2 weeks at 500 mg/m2 for 6 months. The primary endpoint was time to treatment failure (TTF) rate at 9 months. Exploratory analysis of EGFR circulating tumor DNA in plasma was performed. Results: Between June 2016 and November 2018, 59 patients were included in group A and 58 in group A þ C. The study was ended early after a futility analysis was performed. The percentage of patients without treatment failure at 9 months was similar for both groups (59.3% for group A vs. 64.9% for group A þ C), and median TTF was 11.1 (95% CI, 8.5–14.1) and 12.9 (9.2–14.5) months, respectively. Other endpoints, including progression-free survival and overall survival, also showed no improvement with the combination versus afatinib alone. There was a slight numerical increase in grade ≥3 adverse events in group A þ C. Allele frequency of the EGFR gene mutation in circulating tumor DNA at baseline was associated with shorter PFS, regardless of the treatment received. Conclusions: These results suggest that addition of cetuximab to afatinib does not warrant further investigation in treatment-naïve advanced EGFR-mutant NSCLC.Show less >

Language :

Anglais

Peer reviewed article :

Oui

Audience :

Internationale

Popular science :

Non

Collections :

• Cancer Heterogeneity, Plasticity and Resistance to Therapies (CANTHER) - UMR 9020 - UMR 1277

Source :

Harvested from HAL