Evidence map›Paper›PMID 27032107›Full record

Trial reportPloS one2016

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).

Jacques De Grève, Jan Van Meerbeeck, Johan F Vansteenkiste, Lore Decoster, Anne-Pascale Meert, Peter Vuylsteke, Christian Focan, Jean-Luc Canon, Yves Humblet, Guy Berchem and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in PloS one, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00339586 (Prospective Evaluation of Small Molecule EGFR-1 Tyrosine Kinase Inhibition as a First-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
4.1field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00339586 phase2unknown statusnot on this map

Prospective Evaluation of Small Molecule EGFR-1 Tyrosine Kinase Inhibition as a First-Line Treatment in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Harbouring a Mutant EGFR Gene

TypeinterventionalSponsorUniversitair Ziekenhuis BrusselRan2006Enrolled40ConditionsLung Neoplasms, Non-Small Cell Lung Cancer, Adenocarcinoma, Bronchiolo-AlveolarArmsErlotinib
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. A systematic review of pharmacoeconomic evaluations of erlotinib in the first-line treatment of advanced non-small cell lung cancer.The European journal of health economics : HEPAC : health economics in prevention and care · 2019
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 2 countries.

Jacques De GrèveDepartment of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Jan Van MeerbeeckDepartment of Thoracic Oncology, University Hospital, Gent, Belgium.
Johan F VansteenkisteDepartment of Pneumology, University Hospital KU Leuven, Leuven, Belgium.
Lore DecosterDepartment of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Anne-Pascale MeertDepartment of Pneumology, Institut Jules Bordet, Brussels, Belgium.
Peter VuylstekeDepartment of Medical Oncology, Clinique et Maternité Sainte-Elisabeth, Namur, Belgium.
Christian FocanDepartment of Medical Oncology, CHC Clinique Saint Joseph, Liège, Belgium.
Jean-Luc CanonDepartment of Medical Oncology, Grand Hôpital de Charleroi, Charleroi, Belgium.
Yves HumbletDepartment of Medical Oncology, Centre du Cancer de l'Université Catholique de Louvain, Brussels, Belgium.
Guy BerchemDepartment of Medical Oncology, Centre Hospitalier du Luxembourg, Luxembourg, Luxembourg.
Benoit ColinetDepartment of Medical Oncology, Grand Hôpital de Charleroi, Charleroi, Belgium.
Danny GaldermansDepartment of Medical Oncology, ZNA Middelheim Hospital, Antwerp, Belgium.
Lionel BosquéeDepartment of Respiratory Medicine, CHU Sart-Tilman, Liège, Belgium.
Joanna VermeijDepartment of Medical Oncology, ZNA Jan Palfijn, Merksem, Belgium.
Alex DewaeleDepartment of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Caroline GeersDepartment of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Denis SchallierDepartment of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Erik TeugelsDepartment of Medical Oncology, Oncologisch Centrum, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Universitair Ziekenhuis Brussel · BEGrand Charleroi Hospital · BEAZ Sint-Jan · BECentre Hospitalier de Luxembourg · LUCentre Hospitalier Universitaire de Liège · BEClinique Saint-Joseph · BEGhent University Hospital · BEInstitut Jules Bordet · BEKU Leuven · BEUCLouvain · BEZNA Middelheim Hospital · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEpidermal 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.

methodsMulticenter 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.

resultsPhenotypic 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.

conclusionThe 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 registrationClinicalTrials.gov NCT00339586.

Indexed as

AdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungDNA Mutational AnalysisErbB ReceptorsErlotinib HydrochlorideFemaleHumansMaleMiddle AgedMutationProspective StudiesSurvival AnalysisTreatment OutcomeWhite PeopleErbB ReceptorsErlotinib Hydrochloride

Identifiers

PMID27032107
PMCPMC4816447
OpenAlexW2328523564

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.