1. LungBEAM: A prospective multicenter study to monitor stage IV NSCLC patients with EGFR mutations using BEAMing technology
- Author
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José Luis González-Larriba, Jose Manuel Trigo, Nuria Viñolas, Rosario Garcίa-Campelo, Angel Artal, Joaquim Bosch-Barrera, Teresa Moran, Carlos Camps, Enriqueta Felip, Bartomeu Massuti, José Miguel Sánchez-Torres, Alfredo Paredes, Luis Paz-Ares, Marta López-Brea, José Palacios, Amelia Insa, Pilar Garrido, Dolores Isla, Margarita Majem, Oscar Juan, Institut Català de la Salut, [Garrido P] Medical Oncology Department, IRYCIS Hospital Universitario Ramón y Cajal, Universidad Alcalá, Madrid, Spain. CIBERONC, Madrid, Spain. [Paz-Ares L] CIBERONC, Madrid, Spain. Medical Oncology Department, Hospital Universitario 12 de Octubre and i+12 Research Institute, Madrid, Spain. Lung Cancer Group, Clinical Research Program, Spanish National Cancer Research Center (CNIO), Madrid, Spain. Complutense University, Madrid, Spain. [Majem M] Medical Oncology Department, Hospital De La Santa Creu I Sant Pau, Barcelona, Spain. Spanish Lung Cancer Group (GECP), Barcelona, Spain. [Morán T] Spanish Lung Cancer Group (GECP), Barcelona, Spain. ICO Badalona, Hospital Germans Trias i Pujol, Barcelona, Spain. [Trigo JM] Medical Oncology Department, Hospital Universitario Virgen de la Victoria, Málaga, Spain. [Bosch-Barrera J] Medical Oncology, Catalan Institute of Oncology (ICO), Dr. Josep Trueta Hospital of Girona, Girona, Spain. [Felip E] Servei d’Oncologia Mèdica, Vall d’Hebron Hospital Universitari, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
- Subjects
Oncology ,Male ,Cancer Research ,Pulmons - Càncer - Prognosi ,Lung Neoplasms ,técnicas de investigación::técnicas genéticas::análisis de secuencias::análisis de secuencias de ADN::análisis de mutaciones del ADN [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS] ,medicine.disease_cause ,BEAMing ,Exon ,non-small cell lung carcinoma ,Interquartile range ,Carcinoma, Non-Small-Cell Lung ,Epidermal growth factor receptor ,Prospective Studies ,RC254-282 ,Research Articles ,Mutation ,medicine.diagnostic_test ,biology ,Hazard ratio ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Neoplasms::Neoplasms by Site::Thoracic Neoplasms::Respiratory Tract Neoplasms::Lung Neoplasms::Bronchial Neoplasms::Carcinoma, Bronchogenic::Carcinoma, Non-Small-Cell Lung [DISEASES] ,ErbB Receptors ,Investigative Techniques::Genetic Techniques::Sequence Analysis::Sequence Analysis, DNA::DNA Mutational Analysis [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT] ,Female ,ADN - Anàlisi ,Research Article ,medicine.medical_specialty ,Otros calificadores::/diagnóstico [Otros calificadores] ,Internal medicine ,Biopsy ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Liquid biopsy ,Aged ,liquid biopsy ,business.industry ,Clinical Cancer Research ,neoplasias::neoplasias por localización::neoplasias torácicas::neoplasias del tracto respiratorio::neoplasias pulmonares::neoplasias de los bronquios::carcinoma broncogénico::carcinoma de pulmón de células no pequeñas [ENFERMEDADES] ,EGFR mutations ,Confidence interval ,non‐small cell lung carcinoma ,respiratory tract diseases ,Neoplasms [DISEASES] ,biology.protein ,business ,Pulmons - Càncer - Tractament - Abstract
Objectives The aim of LungBEAM was to determine the value of a novel epidermal growth factor receptor (EGFR) mutation test in blood based on BEAMing technology to predict disease progression in advanced non‐small cell lung cancer (NSCLC) patients treated with first‐ or second‐generation EGFR‐tyrosine kinase inhibitors (EGFR‐TKIs). Another goal was to monitor the dynamics of EGFR mutations, as well as to track EGFR exon 20 p.T790M (p.T790M) resistance during treatment, as critical indicators of therapeutic efficacy and patient survival. Methods Stage IV NSCLC patients with locally confirmed EGFR‐TKI sensitizing mutations (ex19del and/or L858R) in biopsy tissue who were candidates to receive first‐ or second‐generation EGFR‐TKI as first‐line therapy were included. Plasma samples were obtained at baseline and every 4 weeks during treatment until a progression‐free survival (PFS) event or until study completion (72‐week follow‐up). The mutant allele fraction (MAF) was determined for each identified mutation using BEAMing. Results A total of 68 of the 110 (61.8%) patients experienced a PFS event. Twenty‐six patients (23.6%) presented with an emergent p.T790M mutation in plasma at some point during follow‐up, preceding radiologic progression with a median of 76 (interquartile ratio: 54–111) days. Disease progression correlated with the appearance of p.T790M in plasma with a hazard ratio (HR) of 1.94 (95% confidence interval [CI], 1.48–2.54; p, The manuscript is a multicenter, prospective study conducted in the real‐world setting. The study reveals that the detection and quantification (MAF slope) of EGFR mutations in ctDNA using the highly sensitive BEAMing method may assist in optimizing treatment decisions for advanced NSCLC patients.
- Published
- 2021