Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT)
INTRODUCTION: Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibition is the preferred first-line treatment of advanced adenocarcinoma of the lung that harbors EGFR activating tyrosine kinase domain mutations. Most data available pertain to Asian populations in which such mutations are mo...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4816447/ https://www.ncbi.nlm.nih.gov/pubmed/27032107 http://dx.doi.org/10.1371/journal.pone.0147599 |
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author | De Grève, Jacques Van Meerbeeck, Jan Vansteenkiste, Johan F. Decoster, Lore Meert, Anne-Pascale Vuylsteke, Peter Focan, Christian Canon, Jean-Luc Humblet, Yves Berchem, Guy Colinet, Benoit Galdermans, Danny Bosquée, Lionel Vermeij, Joanna Dewaele, Alex Geers, Caroline Schallier, Denis Teugels, Erik |
author_facet | De Grève, Jacques Van Meerbeeck, Jan Vansteenkiste, Johan F. Decoster, Lore Meert, Anne-Pascale Vuylsteke, Peter Focan, Christian Canon, Jean-Luc Humblet, Yves Berchem, Guy Colinet, Benoit Galdermans, Danny Bosquée, Lionel Vermeij, Joanna Dewaele, Alex Geers, Caroline Schallier, Denis Teugels, Erik |
author_sort | De Grève, Jacques |
collection | PubMed |
description | INTRODUCTION: Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibition is the preferred first-line treatment of advanced adenocarcinoma of the lung that harbors EGFR activating tyrosine kinase domain mutations. Most data available pertain to Asian populations in which such mutations are more prevalent. We report on the long-term results of first-line treatment with erlotinib in Caucasian patients with advanced adenocarcinoma of the lung that have a somatic EGFR mutation in their tumor. METHODS: Multicenter academic prospective phase II study with erlotinib in patients with an activating EGFR tyrosine kinase (TK) domain somatic mutation (any exon encoding the kinase domain) in the tumor and no prior treatment for their advanced disease. RESULTS: Phenotypic preselecting of 229 patients led to a high EGFR mutation detection rate of 24% of which 46 patients were included in the phase II study. With a progression free survival (PFS) of 81% at three months the study met its primary endpoint for presumed superiority over chemotherapy. With an overall median PFS of 11 months and a median overall survival (OS) of 23 months, the results compare favorably with results obtained in randomized studies using TKI in first line in EGFR mutation positive adenocarcinoma of the lung. CONCLUSION: The present study reinforces the use of EGFR tyrosine kinase inhibition (TKI) as a first line treatment of choice for advanced adenocarcinoma of the lung carrying an activating EGFR mutation. The mutation rate in preselected Caucasian patients is higher than previously reported. Issues relevant for clinical practice are discussed. TRIAL REGISTRATION: ClinicalTrials.gov NCT00339586 |
format | Online Article Text |
id | pubmed-4816447 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-48164472016-04-14 Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT) De Grève, Jacques Van Meerbeeck, Jan Vansteenkiste, Johan F. Decoster, Lore Meert, Anne-Pascale Vuylsteke, Peter Focan, Christian Canon, Jean-Luc Humblet, Yves Berchem, Guy Colinet, Benoit Galdermans, Danny Bosquée, Lionel Vermeij, Joanna Dewaele, Alex Geers, Caroline Schallier, Denis Teugels, Erik PLoS One Research Article INTRODUCTION: Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibition is the preferred first-line treatment of advanced adenocarcinoma of the lung that harbors EGFR activating tyrosine kinase domain mutations. Most data available pertain to Asian populations in which such mutations are more prevalent. We report on the long-term results of first-line treatment with erlotinib in Caucasian patients with advanced adenocarcinoma of the lung that have a somatic EGFR mutation in their tumor. METHODS: Multicenter academic prospective phase II study with erlotinib in patients with an activating EGFR tyrosine kinase (TK) domain somatic mutation (any exon encoding the kinase domain) in the tumor and no prior treatment for their advanced disease. RESULTS: Phenotypic preselecting of 229 patients led to a high EGFR mutation detection rate of 24% of which 46 patients were included in the phase II study. With a progression free survival (PFS) of 81% at three months the study met its primary endpoint for presumed superiority over chemotherapy. With an overall median PFS of 11 months and a median overall survival (OS) of 23 months, the results compare favorably with results obtained in randomized studies using TKI in first line in EGFR mutation positive adenocarcinoma of the lung. CONCLUSION: The present study reinforces the use of EGFR tyrosine kinase inhibition (TKI) as a first line treatment of choice for advanced adenocarcinoma of the lung carrying an activating EGFR mutation. The mutation rate in preselected Caucasian patients is higher than previously reported. Issues relevant for clinical practice are discussed. TRIAL REGISTRATION: ClinicalTrials.gov NCT00339586 Public Library of Science 2016-03-31 /pmc/articles/PMC4816447/ /pubmed/27032107 http://dx.doi.org/10.1371/journal.pone.0147599 Text en © 2016 De Grève et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article De Grève, Jacques Van Meerbeeck, Jan Vansteenkiste, Johan F. Decoster, Lore Meert, Anne-Pascale Vuylsteke, Peter Focan, Christian Canon, Jean-Luc Humblet, Yves Berchem, Guy Colinet, Benoit Galdermans, Danny Bosquée, Lionel Vermeij, Joanna Dewaele, Alex Geers, Caroline Schallier, Denis Teugels, Erik Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT) |
title | Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT) |
title_full | Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT) |
title_fullStr | Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT) |
title_full_unstemmed | Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT) |
title_short | Prospective Evaluation of First-Line Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Carrying an Activating EGFR Mutation: A Multicenter Academic Phase II Study in Caucasian Patients (FIELT) |
title_sort | prospective evaluation of first-line erlotinib in advanced non-small cell lung cancer (nsclc) carrying an activating egfr mutation: a multicenter academic phase ii study in caucasian patients (fielt) |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4816447/ https://www.ncbi.nlm.nih.gov/pubmed/27032107 http://dx.doi.org/10.1371/journal.pone.0147599 |
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