U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.
Identifieur interne : 001140 ( Main/Exploration ); précédent : 001139; suivant : 001141U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.
Auteurs : Chana Weinstock [États-Unis] ; Sean Khozin [États-Unis] ; Daniel Suzman [États-Unis] ; Lijun Zhang [États-Unis] ; Shenghui Tang [États-Unis] ; Sakar Wahby [États-Unis] ; Kirsten B. Goldberg [États-Unis] ; Geoffrey Kim [États-Unis] ; Richard Pazdur [États-Unis]Source :
- Clinical cancer research : an official journal of the American Association for Cancer Research [ 1078-0432 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte (MeSH), Adulte d'âge moyen (MeSH), Agrément de médicaments (MeSH), Anticorps monoclonaux (administration et posologie), Anticorps monoclonaux (effets indésirables), Anticorps monoclonaux humanisés (MeSH), Carcinome pulmonaire non à petites cellules (anatomopathologie), Carcinome pulmonaire non à petites cellules (traitement médicamenteux), Docetaxel (MeSH), Dyspnée (induit chimiquement), Essais contrôlés randomisés comme sujet (MeSH), Estimation de Kaplan-Meier (MeSH), Fatigue (induit chimiquement), Femelle (MeSH), Food and Drug Administration (USA) (MeSH), Humains (MeSH), Mâle (MeSH), Protocoles de polychimiothérapie antinéoplasique (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Résultat thérapeutique (MeSH), Sujet âgé (MeSH), Sujet âgé de 80 ans ou plus (MeSH), Taxoïdes (administration et posologie), Taxoïdes (effets indésirables), Tumeurs du poumon (anatomopathologie), Tumeurs du poumon (traitement médicamenteux), États-Unis (MeSH).
- MESH :
- administration et posologie : Anticorps monoclonaux, Taxoïdes.
- anatomopathologie : Carcinome pulmonaire non à petites cellules, Tumeurs du poumon.
- effets indésirables : Anticorps monoclonaux, Protocoles de polychimiothérapie antinéoplasique, Taxoïdes.
- induit chimiquement : Dyspnée, Fatigue.
- traitement médicamenteux : Carcinome pulmonaire non à petites cellules, Tumeurs du poumon.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- Adulte, Adulte d'âge moyen, Agrément de médicaments, Anticorps monoclonaux humanisés, Docetaxel, Essais contrôlés randomisés comme sujet, Estimation de Kaplan-Meier, Femelle, Food and Drug Administration (USA), Humains, Mâle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, États-Unis.
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- Adult (MeSH), Aged (MeSH), Aged, 80 and over (MeSH), Antibodies, Monoclonal (administration & dosage), Antibodies, Monoclonal (adverse effects), Antibodies, Monoclonal, Humanized (MeSH), Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Carcinoma, Non-Small-Cell Lung (drug therapy), Carcinoma, Non-Small-Cell Lung (pathology), Docetaxel (MeSH), Drug Approval (MeSH), Dyspnea (chemically induced), Fatigue (chemically induced), Female (MeSH), Humans (MeSH), Kaplan-Meier Estimate (MeSH), Lung Neoplasms (drug therapy), Lung Neoplasms (pathology), Male (MeSH), Middle Aged (MeSH), Randomized Controlled Trials as Topic (MeSH), Taxoids (administration & dosage), Taxoids (adverse effects), Treatment Outcome (MeSH), United States (MeSH), United States Food and Drug Administration (MeSH).
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Taxoids.
- chemical , adverse effects : Antibodies, Monoclonal, Taxoids.
- geographic : United States.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols.
- chemically induced : Dyspnea, Fatigue.
- drug therapy : Carcinoma, Non-Small-Cell Lung, Lung Neoplasms.
- pathology : Carcinoma, Non-Small-Cell Lung, Lung Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized, Docetaxel, Drug Approval, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Randomized Controlled Trials as Topic, Treatment Outcome, United States Food and Drug Administration.
Abstract
On October 18, 2016, the FDA approved atezolizumab (TECENTRIQ; Genentech, Inc.) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose disease progressed during or following platinum-containing chemotherapy. Approval was based on demonstration of clinically meaningful improvements in overall survival (OS) and an acceptable safety profile in two randomized clinical trials (OAK and POPLAR). Median OS in OAK, a phase III trial, was 13.8 months [95% confidence interval (CI), 11.8-15.7] in the atezolizumab arm compared with 9.6 months (95% CI, 8.6-11.2) in the docetaxel arm [hazard ratio (HR) = 0.74; 95% CI, 0.63-0.87; P = 0.0004]. Median OS in POPLAR, a phase II trial, was 12.6 months (95% CI, 9.7-16.0) and 9.7 months (95% CI, 8.6-12.0; HR = 0.69; 95% CI, 0.52-0.92) for the atezolizumab and docetaxel arms, respectively. In patients treated with atezolizumab, the most common (≥20%) adverse reactions were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation; the most common (≥2%) grade 3 to 4 adverse events were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, aspartate aminotransferase increase, alanine aminotransferase increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab included 1.4% incidence each of grade 3 to 4 pneumonitis, hepatitis, colitis, and thyroid disease. Clin Cancer Res; 23(16); 4534-9. ©2017 AACR.
DOI: 10.1158/1078-0432.CCR-17-0540
PubMed: 28611199
Affiliations:
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Spring</wicri:cityArea></affiliation></author><author><name sortKey="Wahby, Sakar" sort="Wahby, Sakar" uniqKey="Wahby S" first="Sakar" last="Wahby">Sakar Wahby</name><affiliation wicri:level="2"><nlm:affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring</wicri:cityArea></affiliation></author><author><name sortKey="Goldberg, Kirsten B" sort="Goldberg, Kirsten B" uniqKey="Goldberg K" first="Kirsten B" last="Goldberg">Kirsten B. Goldberg</name><affiliation wicri:level="2"><nlm:affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring</wicri:cityArea></affiliation></author><author><name sortKey="Kim, Geoffrey" sort="Kim, Geoffrey" uniqKey="Kim G" first="Geoffrey" last="Kim">Geoffrey Kim</name><affiliation wicri:level="2"><nlm:affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring</wicri:cityArea></affiliation></author><author><name sortKey="Pazdur, Richard" sort="Pazdur, Richard" uniqKey="Pazdur R" first="Richard" last="Pazdur">Richard Pazdur</name><affiliation wicri:level="2"><nlm:affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</nlm:affiliation><country xml:lang="fr">États-Unis</country><placeName><region type="state">Maryland</region></placeName><wicri:cityArea>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring</wicri:cityArea></affiliation></author></analytic><series><title level="j">Clinical cancer research : an official journal of the American Association for Cancer Research</title><idno type="ISSN">1078-0432</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term><term>Aged (MeSH)</term><term>Aged, 80 and over (MeSH)</term><term>Antibodies, Monoclonal (administration & dosage)</term><term>Antibodies, Monoclonal (adverse effects)</term><term>Antibodies, Monoclonal, Humanized (MeSH)</term><term>Antineoplastic Combined Chemotherapy Protocols (adverse effects)</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Carcinoma, Non-Small-Cell Lung (drug therapy)</term><term>Carcinoma, Non-Small-Cell Lung (pathology)</term><term>Docetaxel (MeSH)</term><term>Drug Approval (MeSH)</term><term>Dyspnea (chemically induced)</term><term>Fatigue (chemically induced)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Kaplan-Meier Estimate (MeSH)</term><term>Lung Neoplasms (drug therapy)</term><term>Lung Neoplasms (pathology)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Randomized Controlled Trials as Topic (MeSH)</term><term>Taxoids (administration & dosage)</term><term>Taxoids (adverse effects)</term><term>Treatment Outcome (MeSH)</term><term>United States (MeSH)</term><term>United States Food and Drug Administration (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte (MeSH)</term><term>Adulte d'âge moyen (MeSH)</term><term>Agrément de médicaments (MeSH)</term><term>Anticorps monoclonaux (administration et posologie)</term><term>Anticorps monoclonaux (effets indésirables)</term><term>Anticorps monoclonaux humanisés (MeSH)</term><term>Carcinome pulmonaire non à petites cellules (anatomopathologie)</term><term>Carcinome pulmonaire non à petites cellules (traitement médicamenteux)</term><term>Docetaxel (MeSH)</term><term>Dyspnée (induit chimiquement)</term><term>Essais contrôlés randomisés comme sujet (MeSH)</term><term>Estimation de Kaplan-Meier (MeSH)</term><term>Fatigue (induit chimiquement)</term><term>Femelle (MeSH)</term><term>Food and Drug Administration (USA) (MeSH)</term><term>Humains (MeSH)</term><term>Mâle (MeSH)</term><term>Protocoles de polychimiothérapie antinéoplasique (effets indésirables)</term><term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term><term>Résultat thérapeutique (MeSH)</term><term>Sujet âgé (MeSH)</term><term>Sujet âgé de 80 ans ou plus (MeSH)</term><term>Taxoïdes (administration et posologie)</term><term>Taxoïdes (effets indésirables)</term><term>Tumeurs du poumon (anatomopathologie)</term><term>Tumeurs du poumon (traitement médicamenteux)</term><term>États-Unis (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Taxoids</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal</term><term>Taxoids</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>United States</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Taxoïdes</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Carcinome pulmonaire non à petites cellules</term><term>Tumeurs du poumon</term></keywords><keywords scheme="MESH" qualifier="chemically induced" xml:lang="en"><term>Dyspnea</term><term>Fatigue</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Carcinoma, Non-Small-Cell Lung</term><term>Lung Neoplasms</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Anticorps monoclonaux</term><term>Protocoles de polychimiothérapie antinéoplasique</term><term>Taxoïdes</term></keywords><keywords scheme="MESH" qualifier="induit chimiquement" xml:lang="fr"><term>Dyspnée</term><term>Fatigue</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Carcinoma, Non-Small-Cell Lung</term><term>Lung Neoplasms</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Carcinome pulmonaire non à petites cellules</term><term>Tumeurs du poumon</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antibodies, Monoclonal, Humanized</term><term>Docetaxel</term><term>Drug Approval</term><term>Female</term><term>Humans</term><term>Kaplan-Meier Estimate</term><term>Male</term><term>Middle Aged</term><term>Randomized Controlled Trials as Topic</term><term>Treatment Outcome</term><term>United States Food and Drug Administration</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte</term><term>Adulte d'âge moyen</term><term>Agrément de médicaments</term><term>Anticorps monoclonaux humanisés</term><term>Docetaxel</term><term>Essais contrôlés randomisés comme sujet</term><term>Estimation de Kaplan-Meier</term><term>Femelle</term><term>Food and Drug Administration (USA)</term><term>Humains</term><term>Mâle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term><term>États-Unis</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>États-Unis</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">On October 18, 2016, the FDA approved atezolizumab (TECENTRIQ; Genentech, Inc.) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose disease progressed during or following platinum-containing chemotherapy. Approval was based on demonstration of clinically meaningful improvements in overall survival (OS) and an acceptable safety profile in two randomized clinical trials (OAK and POPLAR). Median OS in OAK, a phase III trial, was 13.8 months [95% confidence interval (CI), 11.8-15.7] in the atezolizumab arm compared with 9.6 months (95% CI, 8.6-11.2) in the docetaxel arm [hazard ratio (HR) = 0.74; 95% CI, 0.63-0.87; <i>P</i> = 0.0004]. Median OS in POPLAR, a phase II trial, was 12.6 months (95% CI, 9.7-16.0) and 9.7 months (95% CI, 8.6-12.0; HR = 0.69; 95% CI, 0.52-0.92) for the atezolizumab and docetaxel arms, respectively. In patients treated with atezolizumab, the most common (≥20%) adverse reactions were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation; the most common (≥2%) grade 3 to 4 adverse events were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, aspartate aminotransferase increase, alanine aminotransferase increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab included 1.4% incidence each of grade 3 to 4 pneumonitis, hepatitis, colitis, and thyroid disease. <i>Clin Cancer Res; 23(16); 4534-9. ©2017 AACR</i>.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28611199</PMID><DateCompleted><Year>2018</Year><Month>04</Month><Day>30</Day></DateCompleted><DateRevised><Year>2019</Year><Month>12</Month><Day>10</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">1078-0432</ISSN><JournalIssue CitedMedium="Internet"><Volume>23</Volume><Issue>16</Issue><PubDate><Year>2017</Year><Month>Aug</Month><Day>15</Day></PubDate></JournalIssue><Title>Clinical cancer research : an official journal of the American Association for Cancer Research</Title><ISOAbbreviation>Clin Cancer Res</ISOAbbreviation></Journal><ArticleTitle>U.S. Food and Drug Administration Approval Summary: Atezolizumab for Metastatic Non-Small Cell Lung Cancer.</ArticleTitle><Pagination><MedlinePgn>4534-4539</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1158/1078-0432.CCR-17-0540</ELocationID><Abstract><AbstractText>On October 18, 2016, the FDA approved atezolizumab (TECENTRIQ; Genentech, Inc.) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose disease progressed during or following platinum-containing chemotherapy. Approval was based on demonstration of clinically meaningful improvements in overall survival (OS) and an acceptable safety profile in two randomized clinical trials (OAK and POPLAR). Median OS in OAK, a phase III trial, was 13.8 months [95% confidence interval (CI), 11.8-15.7] in the atezolizumab arm compared with 9.6 months (95% CI, 8.6-11.2) in the docetaxel arm [hazard ratio (HR) = 0.74; 95% CI, 0.63-0.87; <i>P</i> = 0.0004]. Median OS in POPLAR, a phase II trial, was 12.6 months (95% CI, 9.7-16.0) and 9.7 months (95% CI, 8.6-12.0; HR = 0.69; 95% CI, 0.52-0.92) for the atezolizumab and docetaxel arms, respectively. In patients treated with atezolizumab, the most common (≥20%) adverse reactions were fatigue, decreased appetite, dyspnea, cough, nausea, musculoskeletal pain, and constipation; the most common (≥2%) grade 3 to 4 adverse events were dyspnea, pneumonia, hypoxia, hyponatremia, fatigue, anemia, musculoskeletal pain, aspartate aminotransferase increase, alanine aminotransferase increase, dysphagia, and arthralgia. Clinically significant immune-related adverse events for patients receiving atezolizumab included 1.4% incidence each of grade 3 to 4 pneumonitis, hepatitis, colitis, and thyroid disease. <i>Clin Cancer Res; 23(16); 4534-9. ©2017 AACR</i>.</AbstractText><CopyrightInformation>©2017 American Association for Cancer Research.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Weinstock</LastName><ForeName>Chana</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland. chana.weinstock@fda.hhs.gov.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Khozin</LastName><ForeName>Sean</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Suzman</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Lijun</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tang</LastName><ForeName>Shenghui</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wahby</LastName><ForeName>Sakar</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goldberg</LastName><ForeName>Kirsten B</ForeName><Initials>KB</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kim</LastName><ForeName>Geoffrey</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pazdur</LastName><ForeName>Richard</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>06</Month><Day>13</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Clin Cancer Res</MedlineTA><NlmUniqueID>9502500</NlmUniqueID><ISSNLinking>1078-0432</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000911">Antibodies, Monoclonal</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D043823">Taxoids</NameOfSubstance></Chemical><Chemical><RegistryNumber>15H5577CQD</RegistryNumber><NameOfSubstance UI="D000077143">Docetaxel</NameOfSubstance></Chemical><Chemical><RegistryNumber>52CMI0WC3Y</RegistryNumber><NameOfSubstance UI="C000594389">atezolizumab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000911" MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D061067" MajorTopicYN="N">Antibodies, Monoclonal, Humanized</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002289" MajorTopicYN="N">Carcinoma, Non-Small-Cell Lung</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000077143" MajorTopicYN="N">Docetaxel</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D017277" MajorTopicYN="Y">Drug Approval</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004417" MajorTopicYN="N">Dyspnea</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005221" MajorTopicYN="N">Fatigue</DescriptorName><QualifierName UI="Q000139" MajorTopicYN="N">chemically induced</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008175" MajorTopicYN="N">Lung Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D043823" MajorTopicYN="N">Taxoids</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014486" MajorTopicYN="N">United States Food and Drug Administration</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>03</Month><Day>09</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2017</Year><Month>05</Month><Day>01</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2017</Year><Month>06</Month><Day>07</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>6</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2018</Year><Month>5</Month><Day>1</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>6</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28611199</ArticleId><ArticleId IdType="pii">1078-0432.CCR-17-0540</ArticleId><ArticleId IdType="doi">10.1158/1078-0432.CCR-17-0540</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Maryland</li></region></list><tree><country name="États-Unis"><region name="Maryland"><name sortKey="Weinstock, Chana" sort="Weinstock, Chana" uniqKey="Weinstock C" first="Chana" last="Weinstock">Chana Weinstock</name></region><name sortKey="Goldberg, Kirsten B" sort="Goldberg, Kirsten B" uniqKey="Goldberg K" first="Kirsten B" last="Goldberg">Kirsten B. Goldberg</name><name sortKey="Khozin, Sean" sort="Khozin, Sean" uniqKey="Khozin S" first="Sean" last="Khozin">Sean Khozin</name><name sortKey="Kim, Geoffrey" sort="Kim, Geoffrey" uniqKey="Kim G" first="Geoffrey" last="Kim">Geoffrey Kim</name><name sortKey="Pazdur, Richard" sort="Pazdur, Richard" uniqKey="Pazdur R" first="Richard" last="Pazdur">Richard Pazdur</name><name sortKey="Suzman, Daniel" sort="Suzman, Daniel" uniqKey="Suzman D" first="Daniel" last="Suzman">Daniel Suzman</name><name sortKey="Tang, Shenghui" sort="Tang, Shenghui" uniqKey="Tang S" first="Shenghui" last="Tang">Shenghui Tang</name><name sortKey="Wahby, Sakar" sort="Wahby, Sakar" uniqKey="Wahby S" first="Sakar" last="Wahby">Sakar Wahby</name><name sortKey="Zhang, Lijun" sort="Zhang, Lijun" uniqKey="Zhang L" first="Lijun" last="Zhang">Lijun Zhang</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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