Evidence map›Paper›PMID 28426106›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017

Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial.

L Paz-Ares, E-H Tan, K O'Byrne, L Zhang, V Hirsh, M Boyer, J C-H Yang, T Mok, K H Lee, S Lu and 10 more

4 registry-linked trialsAbstract readClinical Trial, Phase IIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 279 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
279citing papers in PubMed, 13 pooled it
–field-weighted citation impact
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.

NCT01466660 phase2completednot on this map

LUX-Lung 7: A Randomised, Open-label Phase IIb Trial of Afatinib Versus Gefitinib as First-line Treatment of Patients With EGFR Mutation Positive Advanced Adenocarcinoma of the Lung

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2019Enrolled319ConditionsLung NeoplasmsArmsAfatinib, gefitinib
NCT04640870 completednot on this map

An Observational Study to Assess the Molecular Epidemiology of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients With Advanced EGFR Mutation-positive Non-small Cell Lung Cancer Treated With Afatinib in Real-world Clinical Set-tings in Greece

TypeobservationalSponsorHellenic Cooperative Oncology GroupRan2015 to 2020Enrolled59ConditionsNon Small Cell Lung Cancer, EGF-R Positive Non-Small Cell Lung Cancer, EGFR Gene MutationArmsAfatinib
NCT06643416 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Efficacy and Safety of Add-on Topical Timolol in the Management of Epidermal Growth Factor and Anaplastic Lymphoma Kinase Receptor Tyrosine Kinase Inhibitor-induced Paronychia: a Prospective Randomized Open-labelled Trial

TypeinterventionalSponsorQueen Mary Hospital, Hong KongRan2024 to 2025Enrolled40ConditionsParonychia, EGFR-TKI, ALK-TKIArmsTimolol 0.5% eye drops and betamethasone valerate 0.1% cream, Betamethasone valerate 0.1% cream
NCT06759857 phase3enrolling by invitationnot on this mapstarted 2021, after this paper: background citation

A Randomized, Open, Positives Parallel-controlled, Multicenter Phase III to Evaluate the Efficacy and Safety of FHND9041 Versus Afatinib in First-line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer

TypeinterventionalSponsorJiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.Ran2021 to 2025Enrolled350ConditionsNon Small Cell Lung CancerArmsFHND9041, Afatinib
3 · Its place in the literature

Who cites it

279 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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219 more citing papers are in PubMed but not listed here.

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

20 authors.

L Paz-AresMedical Oncology Department, Hospital Universitario Doce de Octubre, Universidad Complutense and CNIO, Madrid, Spain.
E-H TanDivision of Medical Oncology, National Cancer Centre, Singapore.
K O'ByrneCancer Section, Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Australia.
L ZhangState Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.
V HirshDepartment of Oncology, McGill University, Montreal, Canada.
M BoyerDepartment of Medical Oncology, Chris O'Brien Lifehouse, Camperdown, Australia.
J C-H YangDepartment of Oncology, National Taiwan University Hospital and National Taiwan University, Taipei, Taiwan.
T MokDepartment of Clinical Oncology, State Key Laboratory of South China, The Chinese University of Hong Kong, Hong Kong.
K H LeeDepartment of Internal Medicine, Chungbuk National University Hospital, Cheongju, Chungbuk, South Korea.
S LuShanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai.
Y ShiDepartment of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
D H LeeDepartment of Oncology, Asan Medical Center, Seoul, South Korea.
J LaskinMedical Oncology, BC Cancer Agency, Vancouver, British Columbia, Canada.
D-W KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
S A LaurieDivision of Medical Oncology, The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada.
K KölbeckPulmonary Diseases, Karolinska University Hospital, Solna, Stockholm, Sweden.
J FanClinical Program Leader, Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, USA.
N DoddBiostatistics, Boehringer Ingelheim Ltd UK, Bracknell, UK.
A MärtenTA Oncology, Boehringer Ingelheim GmbH, Ingelheim, Germany.
K ParkDivision of Hematology/Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: In LUX-Lung 7, the irreversible ErbB family blocker, afatinib, significantly improved progression-free survival (PFS), time-to-treatment failure (TTF) and objective response rate (ORR) versus gefitinib in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Here, we present primary analysis of mature overall survival (OS) data. Patients and methods: LUX-Lung 7 assessed afatinib 40 mg/day versus gefitinib 250 mg/day in treatment-naïve patients with stage IIIb/IV NSCLC and a common EGFR mutation (exon 19 deletion/L858R). Primary OS analysis was planned after ∼213 OS events and ≥32-month follow-up. OS was analysed by a Cox proportional hazards model, stratified by EGFR mutation type and baseline brain metastases. Results: Two-hundred and twenty-six OS events had occurred at the data cut-off (8 April 2016). After a median follow-up of 42.6 months, median OS (afatinib versus gefitinib) was 27.9 versus 24.5 months [hazard ratio (HR) = 0.86, 95% confidence interval (CI) 0.66‒1.12, P = 0.2580]. Prespecified subgroup analyses showed similar OS trends (afatinib versus gefitinib) in patients with exon 19 deletion (30.7 versus 26.4 months; HR, 0.83, 95% CI 0.58‒1.17, P = 0.2841) and L858R (25.0 versus 21.2 months; HR 0.91, 95% CI 0.62‒1.36, P = 0.6585) mutations. Most patients (afatinib, 72.6%; gefitinib, 76.8%) had at least one subsequent systemic anti-cancer treatment following discontinuation of afatinib/gefitinib; 20 (13.7%) and 23 (15.2%) patients received a third-generation EGFR tyrosine kinase inhibitor. Updated PFS (independent review), TTF and ORR data were significantly improved with afatinib. Conclusion: In LUX-Lung 7, there was no significant difference in OS with afatinib versus gefitinib. Updated PFS (independent review), TTF and ORR data were significantly improved with afatinib. Clinicaltrials.gov identifier: NCT01466660.

Indexed as

AfatinibAgedAntineoplastic AgentsCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleGefitinibHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMutationProportional Hazards ModelsQuinazolinesTreatment OutcomeAfatinibAntineoplastic AgentsEGFR protein, humanErbB ReceptorsGefitinibQuinazolinesafatinibgefitinibNSCLCoverall survival

Identifiers

PMID28426106
PMCPMC5391700

What OpenQuestion holds

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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.