Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial.
Identifieur interne : 001E66 ( PubMed/Corpus ); précédent : 001E65; suivant : 001E67Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial.
Auteurs : Keunchil Park ; Eng-Huat Tan ; Ken O'Byrne ; Li Zhang ; Michael Boyer ; Tony Mok ; Vera Hirsh ; James Chih-Hsin Yang ; Ki Hyeong Lee ; Shun Lu ; Yuankai Shi ; Sang-We Kim ; Janessa Laskin ; Dong-Wan Kim ; Catherine Dubos Arvis ; Karl Kölbeck ; Scott A. Laurie ; Chun-Ming Tsai ; Mehdi Shahidi ; Miyoung Kim ; Dan Massey ; Victoria Zazulina ; Luis Paz-AresSource :
- The Lancet. Oncology [ 1474-5488 ] ; 2016.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung (drug therapy), Carcinoma, Non-Small-Cell Lung (genetics), Carcinoma, Non-Small-Cell Lung (pathology), Disease-Free Survival, Drug-Related Side Effects and Adverse Reactions (classification), Drug-Related Side Effects and Adverse Reactions (genetics), Drug-Related Side Effects and Adverse Reactions (physiopathology), Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Mutation, Protein Kinase Inhibitors (administration & dosage), Protein Kinase Inhibitors (adverse effects), Quinazolines (administration & dosage), Quinazolines (adverse effects), Receptor, Epidermal Growth Factor (genetics).
- MESH :
- chemical , administration & dosage : Protein Kinase Inhibitors, Quinazolines.
- chemical , adverse effects : Protein Kinase Inhibitors, Quinazolines.
- classification : Drug-Related Side Effects and Adverse Reactions.
- drug therapy : Carcinoma, Non-Small-Cell Lung.
- genetics : Carcinoma, Non-Small-Cell Lung, Drug-Related Side Effects and Adverse Reactions, Receptor, Epidermal Growth Factor.
- pathology : Carcinoma, Non-Small-Cell Lung.
- physiopathology : Drug-Related Side Effects and Adverse Reactions.
- Adult, Aged, Aged, 80 and over, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Mutation.
Abstract
The irreversible ErbB family blocker afatinib and the reversible EGFR tyrosine kinase inhibitor gefitinib are approved for first-line treatment of EGFR mutation-positive non-small-cell lung cancer (NSCLC). We aimed to compare the efficacy and safety of afatinib and gefitinib in this setting.
DOI: 10.1016/S1470-2045(16)30033-X
PubMed: 27083334
Links to Exploration step
pubmed:27083334Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial.</title><author><name sortKey="Park, Keunchil" sort="Park, Keunchil" uniqKey="Park K" first="Keunchil" last="Park">Keunchil Park</name><affiliation><nlm:affiliation>Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: kpark@skku.edu.</nlm:affiliation></affiliation></author><author><name sortKey="Tan, Eng Huat" sort="Tan, Eng Huat" uniqKey="Tan E" first="Eng-Huat" last="Tan">Eng-Huat Tan</name><affiliation><nlm:affiliation>National Cancer Centre, Singapore, Singapore.</nlm:affiliation></affiliation></author><author><name sortKey="O Byrne, Ken" sort="O Byrne, Ken" uniqKey="O Byrne K" first="Ken" last="O'Byrne">Ken O'Byrne</name><affiliation><nlm:affiliation>Princess Alexandra Hospital and Queensland University of Technology, Brisbane, QLD, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Zhang, Li" sort="Zhang, Li" uniqKey="Zhang L" first="Li" last="Zhang">Li Zhang</name><affiliation><nlm:affiliation>State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.</nlm:affiliation></affiliation></author><author><name sortKey="Boyer, Michael" sort="Boyer, Michael" uniqKey="Boyer M" first="Michael" last="Boyer">Michael Boyer</name><affiliation><nlm:affiliation>Chris O'Brien Lifehouse, Camperdown, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Mok, Tony" sort="Mok, Tony" uniqKey="Mok T" first="Tony" last="Mok">Tony Mok</name><affiliation><nlm:affiliation>Key Laboratory of South China, Department of Clinical Oncology, The Chinese University of Hong Kong Sha Tin, Hong Kong.</nlm:affiliation></affiliation></author><author><name sortKey="Hirsh, Vera" sort="Hirsh, Vera" uniqKey="Hirsh V" first="Vera" last="Hirsh">Vera Hirsh</name><affiliation><nlm:affiliation>McGill University, Montreal, QC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Yang, James Chih Hsin" sort="Yang, James Chih Hsin" uniqKey="Yang J" first="James Chih-Hsin" last="Yang">James Chih-Hsin Yang</name><affiliation><nlm:affiliation>National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Lee, Ki Hyeong" sort="Lee, Ki Hyeong" uniqKey="Lee K" first="Ki Hyeong" last="Lee">Ki Hyeong Lee</name><affiliation><nlm:affiliation>Chungbuk National University Hospital, Cheongju, Chungbuk, South Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Lu, Shun" sort="Lu, Shun" uniqKey="Lu S" first="Shun" last="Lu">Shun Lu</name><affiliation><nlm:affiliation>Shanghai Chest Hospital, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Shi, Yuankai" sort="Shi, Yuankai" uniqKey="Shi Y" first="Yuankai" last="Shi">Yuankai Shi</name><affiliation><nlm:affiliation>Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Sang We" sort="Kim, Sang We" uniqKey="Kim S" first="Sang-We" last="Kim">Sang-We Kim</name><affiliation><nlm:affiliation>Asan Medical Center, Seoul, South Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Laskin, Janessa" sort="Laskin, Janessa" uniqKey="Laskin J" first="Janessa" last="Laskin">Janessa Laskin</name><affiliation><nlm:affiliation>BC CancerAgency, Vancouver, BC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Dong Wan" sort="Kim, Dong Wan" uniqKey="Kim D" first="Dong-Wan" last="Kim">Dong-Wan Kim</name><affiliation><nlm:affiliation>Seoul National University Hospital, Seoul, South Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Arvis, Catherine Dubos" sort="Arvis, Catherine Dubos" uniqKey="Arvis C" first="Catherine Dubos" last="Arvis">Catherine Dubos Arvis</name><affiliation><nlm:affiliation>Centre François Baclesse, Oncology, Caen, France.</nlm:affiliation></affiliation></author><author><name sortKey="Kolbeck, Karl" sort="Kolbeck, Karl" uniqKey="Kolbeck K" first="Karl" last="Kölbeck">Karl Kölbeck</name><affiliation><nlm:affiliation>Karolinska University Hospital, Solna, Stockholm, Sweden.</nlm:affiliation></affiliation></author><author><name sortKey="Laurie, Scott A" sort="Laurie, Scott A" uniqKey="Laurie S" first="Scott A" last="Laurie">Scott A. Laurie</name><affiliation><nlm:affiliation>The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Tsai, Chun Ming" sort="Tsai, Chun Ming" uniqKey="Tsai C" first="Chun-Ming" last="Tsai">Chun-Ming Tsai</name><affiliation><nlm:affiliation>Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Shahidi, Mehdi" sort="Shahidi, Mehdi" uniqKey="Shahidi M" first="Mehdi" last="Shahidi">Mehdi Shahidi</name><affiliation><nlm:affiliation>Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Miyoung" sort="Kim, Miyoung" uniqKey="Kim M" first="Miyoung" last="Kim">Miyoung Kim</name><affiliation><nlm:affiliation>Boehringer Ingelheim GmbH, Ingelheim, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Massey, Dan" sort="Massey, Dan" uniqKey="Massey D" first="Dan" last="Massey">Dan Massey</name><affiliation><nlm:affiliation>Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Zazulina, Victoria" sort="Zazulina, Victoria" uniqKey="Zazulina V" first="Victoria" last="Zazulina">Victoria Zazulina</name><affiliation><nlm:affiliation>Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Paz Ares, Luis" sort="Paz Ares, Luis" uniqKey="Paz Ares L" first="Luis" last="Paz-Ares">Luis Paz-Ares</name><affiliation><nlm:affiliation>Hospital Universitario Doce de Octubre and CNIO, Madrid Spain.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27083334</idno><idno type="pmid">27083334</idno><idno type="doi">10.1016/S1470-2045(16)30033-X</idno><idno type="wicri:Area/PubMed/Corpus">001E66</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001E66</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial.</title><author><name sortKey="Park, Keunchil" sort="Park, Keunchil" uniqKey="Park K" first="Keunchil" last="Park">Keunchil Park</name><affiliation><nlm:affiliation>Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: kpark@skku.edu.</nlm:affiliation></affiliation></author><author><name sortKey="Tan, Eng Huat" sort="Tan, Eng Huat" uniqKey="Tan E" first="Eng-Huat" last="Tan">Eng-Huat Tan</name><affiliation><nlm:affiliation>National Cancer Centre, Singapore, Singapore.</nlm:affiliation></affiliation></author><author><name sortKey="O Byrne, Ken" sort="O Byrne, Ken" uniqKey="O Byrne K" first="Ken" last="O'Byrne">Ken O'Byrne</name><affiliation><nlm:affiliation>Princess Alexandra Hospital and Queensland University of Technology, Brisbane, QLD, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Zhang, Li" sort="Zhang, Li" uniqKey="Zhang L" first="Li" last="Zhang">Li Zhang</name><affiliation><nlm:affiliation>State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.</nlm:affiliation></affiliation></author><author><name sortKey="Boyer, Michael" sort="Boyer, Michael" uniqKey="Boyer M" first="Michael" last="Boyer">Michael Boyer</name><affiliation><nlm:affiliation>Chris O'Brien Lifehouse, Camperdown, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Mok, Tony" sort="Mok, Tony" uniqKey="Mok T" first="Tony" last="Mok">Tony Mok</name><affiliation><nlm:affiliation>Key Laboratory of South China, Department of Clinical Oncology, The Chinese University of Hong Kong Sha Tin, Hong Kong.</nlm:affiliation></affiliation></author><author><name sortKey="Hirsh, Vera" sort="Hirsh, Vera" uniqKey="Hirsh V" first="Vera" last="Hirsh">Vera Hirsh</name><affiliation><nlm:affiliation>McGill University, Montreal, QC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Yang, James Chih Hsin" sort="Yang, James Chih Hsin" uniqKey="Yang J" first="James Chih-Hsin" last="Yang">James Chih-Hsin Yang</name><affiliation><nlm:affiliation>National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Lee, Ki Hyeong" sort="Lee, Ki Hyeong" uniqKey="Lee K" first="Ki Hyeong" last="Lee">Ki Hyeong Lee</name><affiliation><nlm:affiliation>Chungbuk National University Hospital, Cheongju, Chungbuk, South Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Lu, Shun" sort="Lu, Shun" uniqKey="Lu S" first="Shun" last="Lu">Shun Lu</name><affiliation><nlm:affiliation>Shanghai Chest Hospital, Shanghai, China.</nlm:affiliation></affiliation></author><author><name sortKey="Shi, Yuankai" sort="Shi, Yuankai" uniqKey="Shi Y" first="Yuankai" last="Shi">Yuankai Shi</name><affiliation><nlm:affiliation>Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Sang We" sort="Kim, Sang We" uniqKey="Kim S" first="Sang-We" last="Kim">Sang-We Kim</name><affiliation><nlm:affiliation>Asan Medical Center, Seoul, South Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Laskin, Janessa" sort="Laskin, Janessa" uniqKey="Laskin J" first="Janessa" last="Laskin">Janessa Laskin</name><affiliation><nlm:affiliation>BC CancerAgency, Vancouver, BC, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Dong Wan" sort="Kim, Dong Wan" uniqKey="Kim D" first="Dong-Wan" last="Kim">Dong-Wan Kim</name><affiliation><nlm:affiliation>Seoul National University Hospital, Seoul, South Korea.</nlm:affiliation></affiliation></author><author><name sortKey="Arvis, Catherine Dubos" sort="Arvis, Catherine Dubos" uniqKey="Arvis C" first="Catherine Dubos" last="Arvis">Catherine Dubos Arvis</name><affiliation><nlm:affiliation>Centre François Baclesse, Oncology, Caen, France.</nlm:affiliation></affiliation></author><author><name sortKey="Kolbeck, Karl" sort="Kolbeck, Karl" uniqKey="Kolbeck K" first="Karl" last="Kölbeck">Karl Kölbeck</name><affiliation><nlm:affiliation>Karolinska University Hospital, Solna, Stockholm, Sweden.</nlm:affiliation></affiliation></author><author><name sortKey="Laurie, Scott A" sort="Laurie, Scott A" uniqKey="Laurie S" first="Scott A" last="Laurie">Scott A. Laurie</name><affiliation><nlm:affiliation>The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Tsai, Chun Ming" sort="Tsai, Chun Ming" uniqKey="Tsai C" first="Chun-Ming" last="Tsai">Chun-Ming Tsai</name><affiliation><nlm:affiliation>Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.</nlm:affiliation></affiliation></author><author><name sortKey="Shahidi, Mehdi" sort="Shahidi, Mehdi" uniqKey="Shahidi M" first="Mehdi" last="Shahidi">Mehdi Shahidi</name><affiliation><nlm:affiliation>Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Miyoung" sort="Kim, Miyoung" uniqKey="Kim M" first="Miyoung" last="Kim">Miyoung Kim</name><affiliation><nlm:affiliation>Boehringer Ingelheim GmbH, Ingelheim, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Massey, Dan" sort="Massey, Dan" uniqKey="Massey D" first="Dan" last="Massey">Dan Massey</name><affiliation><nlm:affiliation>Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Zazulina, Victoria" sort="Zazulina, Victoria" uniqKey="Zazulina V" first="Victoria" last="Zazulina">Victoria Zazulina</name><affiliation><nlm:affiliation>Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Paz Ares, Luis" sort="Paz Ares, Luis" uniqKey="Paz Ares L" first="Luis" last="Paz-Ares">Luis Paz-Ares</name><affiliation><nlm:affiliation>Hospital Universitario Doce de Octubre and CNIO, Madrid Spain.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Carcinoma, Non-Small-Cell Lung (drug therapy)</term><term>Carcinoma, Non-Small-Cell Lung (genetics)</term><term>Carcinoma, Non-Small-Cell Lung (pathology)</term><term>Disease-Free Survival</term><term>Drug-Related Side Effects and Adverse Reactions (classification)</term><term>Drug-Related Side Effects and Adverse Reactions (genetics)</term><term>Drug-Related Side Effects and Adverse Reactions (physiopathology)</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Middle Aged</term><term>Mutation</term><term>Protein Kinase Inhibitors (administration & dosage)</term><term>Protein Kinase Inhibitors (adverse effects)</term><term>Quinazolines (administration & dosage)</term><term>Quinazolines (adverse effects)</term><term>Receptor, Epidermal Growth Factor (genetics)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Protein Kinase Inhibitors</term><term>Quinazolines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Protein Kinase Inhibitors</term><term>Quinazolines</term></keywords><keywords scheme="MESH" qualifier="classification" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Carcinoma, Non-Small-Cell Lung</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Carcinoma, Non-Small-Cell Lung</term><term>Drug-Related Side Effects and Adverse Reactions</term><term>Receptor, Epidermal Growth Factor</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Carcinoma, Non-Small-Cell Lung</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Middle Aged</term><term>Mutation</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The irreversible ErbB family blocker afatinib and the reversible EGFR tyrosine kinase inhibitor gefitinib are approved for first-line treatment of EGFR mutation-positive non-small-cell lung cancer (NSCLC). We aimed to compare the efficacy and safety of afatinib and gefitinib in this setting.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27083334</PMID><DateCreated><Year>2016</Year><Month>06</Month><Day>15</Day></DateCreated><DateCompleted><Year>2017</Year><Month>06</Month><Day>13</Day></DateCompleted><DateRevised><Year>2017</Year><Month>06</Month><Day>13</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>17</Volume><Issue>5</Issue><PubDate><Year>2016</Year><Month>May</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomised controlled trial.</ArticleTitle><Pagination><MedlinePgn>577-89</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(16)30033-X</ELocationID><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(16)30033-X</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">The irreversible ErbB family blocker afatinib and the reversible EGFR tyrosine kinase inhibitor gefitinib are approved for first-line treatment of EGFR mutation-positive non-small-cell lung cancer (NSCLC). We aimed to compare the efficacy and safety of afatinib and gefitinib in this setting.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This multicentre, international, open-label, exploratory, randomised controlled phase 2B trial (LUX-Lung 7) was done at 64 centres in 13 countries. Treatment-naive patients with stage IIIB or IV NSCLC and a common EGFR mutation (exon 19 deletion or Leu858Arg) were randomly assigned (1:1) to receive afatinib (40 mg per day) or gefitinib (250 mg per day) until disease progression, or beyond if deemed beneficial by the investigator. Randomisation, stratified by EGFR mutation type and status of brain metastases, was done centrally using a validated number generating system implemented via an interactive voice or web-based response system with a block size of four. Clinicians and patients were not masked to treatment allocation; independent review of tumour response was done in a blinded manner. Coprimary endpoints were progression-free survival by independent central review, time-to-treatment failure, and overall survival. Efficacy analyses were done in the intention-to-treat population and safety analyses were done in patients who received at least one dose of study drug. This ongoing study is registered with ClinicalTrials.gov, number NCT01466660.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Dec 13, 2011, and Aug 8, 2013, 319 patients were randomly assigned (160 to afatinib and 159 to gefitinib). Median follow-up was 27·3 months (IQR 15·3-33·9). Progression-free survival (median 11·0 months [95% CI 10·6-12·9] with afatinib vs 10·9 months [9·1-11·5] with gefitinib; hazard ratio [HR] 0·73 [95% CI 0·57-0·95], p=0·017) and time-to-treatment failure (median 13·7 months [95% CI 11·9-15·0] with afatinib vs 11·5 months [10·1-13·1] with gefitinib; HR 0·73 [95% CI 0·58-0·92], p=0·0073) were significantly longer with afatinib than with gefitinib. Overall survival data are not mature. The most common treatment-related grade 3 or 4 adverse events were diarrhoea (20 [13%] of 160 patients given afatinib vs two [1%] of 159 given gefitinib) and rash or acne (15 [9%] patients given afatinib vs five [3%] of those given gefitinib) and liver enzyme elevations (no patients given afatinib vs 14 [9%] of those given gefitinib). Serious treatment-related adverse events occurred in 17 (11%) patients in the afatinib group and seven (4%) in the gefitinib group. Ten (6%) patients in each group discontinued treatment due to drug-related adverse events. 15 (9%) fatal adverse events occurred in the afatinib group and ten (6%) in the gefitinib group. All but one of these deaths were considered unrelated to treatment; one patient in the gefitinib group died from drug-related hepatic and renal failure.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Afatinib significantly improved outcomes in treatment-naive patients with EGFR-mutated NSCLC compared with gefitinib, with a manageable tolerability profile. These data are potentially important for clinical decision making in this patient population.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Boehringer Ingelheim.</AbstractText><CopyrightInformation>Copyright © 2016 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Park</LastName><ForeName>Keunchil</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: kpark@skku.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tan</LastName><ForeName>Eng-Huat</ForeName><Initials>EH</Initials><AffiliationInfo><Affiliation>National Cancer Centre, Singapore, Singapore.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>O'Byrne</LastName><ForeName>Ken</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Princess Alexandra Hospital and Queensland University of Technology, Brisbane, QLD, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Li</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Boyer</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Chris O'Brien Lifehouse, Camperdown, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Mok</LastName><ForeName>Tony</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Key Laboratory of South China, Department of Clinical Oncology, The Chinese University of Hong Kong Sha Tin, Hong Kong.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hirsh</LastName><ForeName>Vera</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>McGill University, Montreal, QC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yang</LastName><ForeName>James Chih-Hsin</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lee</LastName><ForeName>Ki Hyeong</ForeName><Initials>KH</Initials><AffiliationInfo><Affiliation>Chungbuk National University Hospital, Cheongju, Chungbuk, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lu</LastName><ForeName>Shun</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Shanghai Chest Hospital, Shanghai, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shi</LastName><ForeName>Yuankai</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, Beijing, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Sang-We</ForeName><Initials>SW</Initials><AffiliationInfo><Affiliation>Asan Medical Center, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Laskin</LastName><ForeName>Janessa</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>BC CancerAgency, Vancouver, BC, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Dong-Wan</ForeName><Initials>DW</Initials><AffiliationInfo><Affiliation>Seoul National University Hospital, Seoul, South Korea.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Arvis</LastName><ForeName>Catherine Dubos</ForeName><Initials>CD</Initials><AffiliationInfo><Affiliation>Centre François Baclesse, Oncology, Caen, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kölbeck</LastName><ForeName>Karl</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Karolinska University Hospital, Solna, Stockholm, Sweden.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Laurie</LastName><ForeName>Scott A</ForeName><Initials>SA</Initials><AffiliationInfo><Affiliation>The Ottawa Hospital Cancer Centre, Ottawa, ON, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tsai</LastName><ForeName>Chun-Ming</ForeName><Initials>CM</Initials><AffiliationInfo><Affiliation>Taipei Veterans General Hospital and National Yang-Ming University, Taipei, Taiwan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shahidi</LastName><ForeName>Mehdi</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Miyoung</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Boehringer Ingelheim GmbH, Ingelheim, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Massey</LastName><ForeName>Dan</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zazulina</LastName><ForeName>Victoria</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Boehringer Ingelheim Ltd UK, Bracknell, Berkshire, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paz-Ares</LastName><ForeName>Luis</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Hospital Universitario Doce de Octubre and CNIO, Madrid Spain.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01466660</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate 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MajorTopicYN="Y">genetics</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>02</Month><Day>03</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>03</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>03</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2016</Year><Month>4</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>4</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>6</Month><Day>14</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27083334</ArticleId><ArticleId IdType="pii">S1470-2045(16)30033-X</ArticleId><ArticleId IdType="doi">10.1016/S1470-2045(16)30033-X</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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