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Efficacy of alectinib in central nervous system metastases in crizotinib-resistant ALK-positive non-small-cell lung cancer: Comparison of RECIST 1.1 and RANO-HGG criteria.

Identifieur interne : 000641 ( PubMed/Curation ); précédent : 000640; suivant : 000642

Efficacy of alectinib in central nervous system metastases in crizotinib-resistant ALK-positive non-small-cell lung cancer: Comparison of RECIST 1.1 and RANO-HGG criteria.

Auteurs : Leena Gandhi [États-Unis] ; Sai-Hong Ignatius Ou [États-Unis] ; Alice T. Shaw [États-Unis] ; Fabrice Barlesi [France] ; Anne-Marie C. Dingemans [Pays-Bas] ; Dong-Wan Kim [Corée du Sud] ; D Ross Camidge [États-Unis] ; Brett G M. Hughes [Australie] ; James C-H Yang [Taïwan] ; Javier De Castro [Espagne] ; Lucio Crino [Italie] ; Hervé Léna [France] ; Pascal Do [France] ; Sophie Golding [Suisse] ; Walter Bordogna [Suisse] ; Ali Zeaiter [Suisse] ; Ahmed Kotb [Suisse] ; Shirish Gadgeel [États-Unis]

Source :

European journal of cancer (Oxford, England : 1990) [ 1879-0852 ] ; 2017.

RBID : pubmed:28646771

Descripteurs français

English descriptors

KwdEn :
- Adult, Aged, Antineoplastic Agents (therapeutic use), Carbazoles (therapeutic use), Carcinoma, Non-Small-Cell Lung (drug therapy), Carcinoma, Non-Small-Cell Lung (pathology), Central Nervous System Neoplasms (drug therapy), Central Nervous System Neoplasms (secondary), Drug Resistance, Neoplasm, Female, Humans, Lung Neoplasms (drug therapy), Lung Neoplasms (pathology), Male, Middle Aged, Piperidines (therapeutic use), Protein Kinase Inhibitors (therapeutic use), Pyrazoles (therapeutic use), Pyridines (therapeutic use), Response Evaluation Criteria in Solid Tumors, Retrospective Studies, Young Adult.
MESH :
- chemical , therapeutic use : Antineoplastic Agents, Carbazoles, Piperidines, Protein Kinase Inhibitors, Pyrazoles, Pyridines.
- drug therapy : Carcinoma, Non-Small-Cell Lung, Central Nervous System Neoplasms, Lung Neoplasms.
- pathology : Carcinoma, Non-Small-Cell Lung, Lung Neoplasms.
- secondary : Central Nervous System Neoplasms.
- Adult, Aged, Drug Resistance, Neoplasm, Female, Humans, Male, Middle Aged, Response Evaluation Criteria in Solid Tumors, Retrospective Studies, Young Adult.

Abstract

Central nervous system (CNS) progression is common in patients with anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) receiving crizotinib. Next-generation ALK inhibitors have shown activity against CNS metastases, but accurate assessment of response and progression is vital. Data from two phase II studies in crizotinib-refractory ALK+ NSCLC were pooled to examine the CNS efficacy of alectinib, a CNS-active ALK inhibitor, using Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) and Response Assessment in Neuro-Oncology high-grade glioma (RANO-HGG) criteria.

DOI: 10.1016/j.ejca.2017.05.019
PubMed: 28646771

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<author><name sortKey="Camidge, D Ross" sort="Camidge, D Ross" uniqKey="Camidge D" first="D Ross" last="Camidge">D Ross Camidge</name>
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<author><name sortKey="Hughes, Brett G M" sort="Hughes, Brett G M" uniqKey="Hughes B" first="Brett G M" last="Hughes">Brett G M. Hughes</name>
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<country xml:lang="fr">Australie</country>
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</affiliation>
</author>
<author><name sortKey="Yang, James C H" sort="Yang, James C H" uniqKey="Yang J" first="James C-H" last="Yang">James C-H Yang</name>
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<country xml:lang="fr">Taïwan</country>
<wicri:regionArea>Department of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei</wicri:regionArea>
</affiliation>
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<author><name sortKey="De Castro, Javier" sort="De Castro, Javier" uniqKey="De Castro J" first="Javier" last="De Castro">Javier De Castro</name>
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<author><name sortKey="Crino, Lucio" sort="Crino, Lucio" uniqKey="Crino L" first="Lucio" last="Crino">Lucio Crino</name>
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<country xml:lang="fr">Italie</country>
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<author><name sortKey="Golding, Sophie" sort="Golding, Sophie" uniqKey="Golding S" first="Sophie" last="Golding">Sophie Golding</name>
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<author><name sortKey="Kotb, Ahmed" sort="Kotb, Ahmed" uniqKey="Kotb A" first="Ahmed" last="Kotb">Ahmed Kotb</name>
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<term>Female</term>
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<term>Lung Neoplasms (drug therapy)</term>
<term>Lung Neoplasms (pathology)</term>
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<term>Response Evaluation Criteria in Solid Tumors</term>
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<term>Adulte d'âge moyen</term>
<term>Antinéoplasiques (usage thérapeutique)</term>
<term>Carbazoles (usage thérapeutique)</term>
<term>Carcinome pulmonaire non à petites cellules (anatomopathologie)</term>
<term>Carcinome pulmonaire non à petites cellules (traitement médicamenteux)</term>
<term>Critères d'évaluation de la réponse dans les tumeurs solides</term>
<term>Femelle</term>
<term>Humains</term>
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<term>Études rétrospectives</term>
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</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="secondaire" xml:lang="fr"><term>Tumeurs du système nerveux central</term>
</keywords>
<keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Central Nervous System Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Carcinome pulmonaire non à petites cellules</term>
<term>Tumeurs du poumon</term>
<term>Tumeurs du système nerveux central</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antinéoplasiques</term>
<term>Carbazoles</term>
<term>Inhibiteurs de protéines kinases</term>
<term>Pipéridines</term>
<term>Pyrazoles</term>
<term>Pyridines</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Drug Resistance, Neoplasm</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Response Evaluation Criteria in Solid Tumors</term>
<term>Retrospective Studies</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Critères d'évaluation de la réponse dans les tumeurs solides</term>
<term>Femelle</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Résistance aux médicaments antinéoplasiques</term>
<term>Sujet âgé</term>
<term>Études rétrospectives</term>
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<front><div type="abstract" xml:lang="en">Central nervous system (CNS) progression is common in patients with anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) receiving crizotinib. Next-generation ALK inhibitors have shown activity against CNS metastases, but accurate assessment of response and progression is vital. Data from two phase II studies in crizotinib-refractory ALK+ NSCLC were pooled to examine the CNS efficacy of alectinib, a CNS-active ALK inhibitor, using Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) and Response Assessment in Neuro-Oncology high-grade glioma (RANO-HGG) criteria.</div>
</front>
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<DateCreated><Year>2017</Year>
<Month>06</Month>
<Day>24</Day>
</DateCreated>
<DateCompleted><Year>2017</Year>
<Month>09</Month>
<Day>07</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>09</Month>
<Day>07</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1879-0852</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>82</Volume>
<PubDate><Year>2017</Year>
<Month>Sep</Month>
</PubDate>
</JournalIssue>
<Title>European journal of cancer (Oxford, England : 1990)</Title>
<ISOAbbreviation>Eur. J. Cancer</ISOAbbreviation>
</Journal>
<ArticleTitle>Efficacy of alectinib in central nervous system metastases in crizotinib-resistant ALK-positive non-small-cell lung cancer: Comparison of RECIST 1.1 and RANO-HGG criteria.</ArticleTitle>
<Pagination><MedlinePgn>27-33</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0959-8049(17)30974-7</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejca.2017.05.019</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Central nervous system (CNS) progression is common in patients with anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer (NSCLC) receiving crizotinib. Next-generation ALK inhibitors have shown activity against CNS metastases, but accurate assessment of response and progression is vital. Data from two phase II studies in crizotinib-refractory ALK+ NSCLC were pooled to examine the CNS efficacy of alectinib, a CNS-active ALK inhibitor, using Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) and Response Assessment in Neuro-Oncology high-grade glioma (RANO-HGG) criteria.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Both studies enrolled patients aged ≥18 years who had previously received crizotinib. NP28761 was conducted in North America and NP28673 was a global study. All patients received 600 mg oral alectinib twice daily and had baseline CNS imaging. CNS response for those with baseline CNS metastases was determined by an independent review committee.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Baseline measurable CNS disease was identified in 50 patients by RECIST and 43 by RANO-HGG. CNS objective response rate was 64.0% by RECIST (95% confidence interval [CI]: 49.2-77.1; 11 CNS complete responses [CCRs]) and 53.5% by RANO-HGG (95% CI: 37.7-68.8; eight CCRs). CNS responses were durable, with consistent estimates of median duration of 10.8 months with RECIST and 11.1 months with RANO-HGG. Of the 39 patients with measurable CNS disease by both RECIST and RANO-HGG, only three (8%) had CNS progression according to one criteria but not the other (92% concordance rate).</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Alectinib demonstrated promising efficacy in the CNS for ALK+ NSCLC patients pretreated with crizotinib, regardless of the assessment criteria used.</AbstractText>
<CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Gandhi</LastName>
<ForeName>Leena</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, New York University, Perlmutter Cancer Center, NYU School of Medicine, New York, USA. Electronic address: leena.gandhi@nyumc.org.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Sai-Hong Ignatius</ForeName>
<Initials>SI</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange, CA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Shaw</LastName>
<ForeName>Alice T</ForeName>
<Initials>AT</Initials>
<AffiliationInfo><Affiliation>Department of Thoracic Oncology, Massachusetts General Hospital, Boston, MA, USA.</Affiliation>
</AffiliationInfo>
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<ForeName>Fabrice</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Dingemans</LastName>
<ForeName>Anne-Marie C</ForeName>
<Initials>AC</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kim</LastName>
<ForeName>Dong-Wan</ForeName>
<Initials>DW</Initials>
<AffiliationInfo><Affiliation>Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Camidge</LastName>
<ForeName>D Ross</ForeName>
<Initials>DR</Initials>
<AffiliationInfo><Affiliation>Department of Medicine, University of Colorado Cancer Center, Denver, CO, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hughes</LastName>
<ForeName>Brett G M</ForeName>
<Initials>BGM</Initials>
<AffiliationInfo><Affiliation>Department of Oncology, The Prince Charles Hospital, and School of Medicine, University of Queensland, Queensland, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Yang</LastName>
<ForeName>James C-H</ForeName>
<Initials>JC</Initials>
<AffiliationInfo><Affiliation>Department of Oncology, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>de Castro</LastName>
<ForeName>Javier</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Medical Oncology Department, Hospital Universitario La Paz, Madrid, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Crino</LastName>
<ForeName>Lucio</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Department of Oncology, Istituto Scientifico Romagnolo per lo studio e la Ricerca dei tumori, IRCCS, Meldola, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Léna</LastName>
<ForeName>Hervé</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Pulmonology Department, Centre Hospitalier Universitaire de Rennes, Rennes, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Do</LastName>
<ForeName>Pascal</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Medical Thoracic Oncology, Centre François Baclesse, Caen, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Golding</LastName>
<ForeName>Sophie</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Biostatistics Department, F. Hoffmann-La Roche Ltd, Basel, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bordogna</LastName>
<ForeName>Walter</ForeName>
<Initials>W</Initials>
<AffiliationInfo><Affiliation>Product Development Oncology, F. Hoffmann-La Roche Ltd, Basel, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Zeaiter</LastName>
<ForeName>Ali</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Pharmaceutical Division, F. Hoffmann-La Roche Ltd, Basel, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kotb</LastName>
<ForeName>Ahmed</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Global Medical Affairs (Oncology), F. Hoffmann-La Roche Ltd, Basel, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gadgeel</LastName>
<ForeName>Shirish</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Department of Oncology, Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2017</Year>
<Month>07</Month>
<Day>10</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Eur J Cancer</MedlineTA>
<NlmUniqueID>9005373</NlmUniqueID>
<ISSNLinking>0959-8049</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000970">Antineoplastic Agents</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="C582670">CH5424802</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
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<NameOfSubstance UI="D010880">Piperidines</NameOfSubstance>
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<Chemical><RegistryNumber>53AH36668S</RegistryNumber>
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<MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
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<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="N">drug therapy</QualifierName>
<QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName>
</MeshHeading>
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<QualifierName UI="Q000556" MajorTopicYN="N">secondary</QualifierName>
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<QualifierName UI="Q000473" MajorTopicYN="Y">pathology</QualifierName>
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<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
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<QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName>
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</MeshHeading>
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<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
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<MeshHeading><DescriptorName UI="D012189" MajorTopicYN="N">Retrospective Studies</DescriptorName>
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<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
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</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Alectinib</Keyword>
<Keyword MajorTopicYN="N">CNS metastases</Keyword>
<Keyword MajorTopicYN="N">NSCLC</Keyword>
<Keyword MajorTopicYN="N">RANO-HGG</Keyword>
<Keyword MajorTopicYN="N">RECIST</Keyword>
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	Serveur d'exploration sur les relations entre la France et l'Australie
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Efficacy of alectinib in central nervous system metastases in crizotinib-resistant ALK-positive non-small-cell lung cancer: Comparison of RECIST 1.1 and RANO-HGG criteria.

Efficacy of alectinib in central nervous system metastases in crizotinib-resistant ALK-positive non-small-cell lung cancer: Comparison of RECIST 1.1 and RANO-HGG criteria.

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