Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas.
Identifieur interne : 001875 ( PubMed/Checkpoint ); précédent : 001874; suivant : 001876Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas.
Auteurs : R K Ramanathan [États-Unis] ; D. Goldstein [Australie] ; R L Korn ; F. Arena [États-Unis] ; M. Moore [Canada] ; S. Siena [Italie] ; L. Teixeira [France] ; J. Tabernero [Espagne] ; J-L Van Laethem [Belgique] ; H. Liu ; D. Mcgovern ; B. Lu ; D D Von Hoff [États-Unis]Source :
- Annals of oncology : official journal of the European Society for Medical Oncology [ 1569-8041 ] ; 2016.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Adénocarcinome (anatomopathologie), Adénocarcinome (imagerie diagnostique), Adénocarcinome (traitement médicamenteux), Albumines (administration et posologie), Calendrier d'administration des médicaments, Désoxycytidine (administration et posologie), Désoxycytidine (analogues et dérivés), Femelle, Humains, Mâle, Métastase tumorale, Paclitaxel (administration et posologie), Protocoles de polychimiothérapie antinéoplasique (administration et posologie), Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Tomographie par émission de positons, Tumeurs du pancréas (anatomopathologie), Tumeurs du pancréas (imagerie diagnostique), Tumeurs du pancréas (traitement médicamenteux).
- MESH :
- administration et posologie : Albumines, Désoxycytidine, Paclitaxel, Protocoles de polychimiothérapie antinéoplasique.
- analogues et dérivés : Désoxycytidine.
- anatomopathologie : Adénocarcinome, Tumeurs du pancréas.
- imagerie diagnostique : Adénocarcinome, Tumeurs du pancréas.
- traitement médicamenteux : Adénocarcinome, Tumeurs du pancréas.
- Adulte, Adulte d'âge moyen, Calendrier d'administration des médicaments, Femelle, Humains, Mâle, Métastase tumorale, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Tomographie par émission de positons.
English descriptors
- KwdEn :
- Adenocarcinoma (diagnostic imaging), Adenocarcinoma (drug therapy), Adenocarcinoma (pathology), Adult, Aged, Aged, 80 and over, Albumins (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (administration & dosage), Deoxycytidine (administration & dosage), Deoxycytidine (analogs & derivatives), Disease-Free Survival, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Paclitaxel (administration & dosage), Pancreatic Neoplasms (diagnostic imaging), Pancreatic Neoplasms (drug therapy), Pancreatic Neoplasms (pathology), Positron-Emission Tomography, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Albumins, Deoxycytidine, Paclitaxel.
- administration & dosage : Antineoplastic Combined Chemotherapy Protocols.
- chemical , analogs & derivatives : Deoxycytidine.
- diagnostic imaging : Adenocarcinoma, Pancreatic Neoplasms.
- drug therapy : Adenocarcinoma, Pancreatic Neoplasms.
- pathology : Adenocarcinoma, Pancreatic Neoplasms.
- Adult, Aged, Aged, 80 and over, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Positron-Emission Tomography, Treatment Outcome.
Abstract
In the phase III MPACT trial, nab-paclitaxel plus gemcitabine (nab-P + Gem) demonstrated superior efficacy versus Gem alone for patients with metastatic pancreatic cancer. We sought to examine the feasibility of positron emission tomography (PET) and to compare metabolic response rates and associated correlations with efficacy in the MPACT trial.
DOI: 10.1093/annonc/mdw020
PubMed: 26802153
Affiliations:
- Australie, Belgique, Canada, Espagne, France, Italie, États-Unis
- Catalogne, Lombardie, Nouvelle-Galles du Sud, Région de Bruxelles-Capitale, Île-de-France
- Barcelone, Bruxelles, Milan, Paris, Sydney
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:26802153Le document en format XML
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<term>Adenocarcinoma (drug therapy)</term>
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<term>Aged</term>
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<term>Deoxycytidine (analogs & derivatives)</term>
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<term>Pancreatic Neoplasms (drug therapy)</term>
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<term>Aged</term>
<term>Aged, 80 and over</term>
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<term>Drug Administration Schedule</term>
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<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Neoplasm Metastasis</term>
<term>Positron-Emission Tomography</term>
<term>Treatment Outcome</term>
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<term>Adulte d'âge moyen</term>
<term>Calendrier d'administration des médicaments</term>
<term>Femelle</term>
<term>Humains</term>
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<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
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<front><div type="abstract" xml:lang="en">In the phase III MPACT trial, nab-paclitaxel plus gemcitabine (nab-P + Gem) demonstrated superior efficacy versus Gem alone for patients with metastatic pancreatic cancer. We sought to examine the feasibility of positron emission tomography (PET) and to compare metabolic response rates and associated correlations with efficacy in the MPACT trial.</div>
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<JournalIssue CitedMedium="Internet"><Volume>27</Volume>
<Issue>4</Issue>
<PubDate><Year>2016</Year>
<Month>Apr</Month>
</PubDate>
</JournalIssue>
<Title>Annals of oncology : official journal of the European Society for Medical Oncology</Title>
<ISOAbbreviation>Ann. Oncol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Positron emission tomography response evaluation from a randomized phase III trial of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone for patients with metastatic adenocarcinoma of the pancreas.</ArticleTitle>
<Pagination><MedlinePgn>648-53</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1093/annonc/mdw020</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">In the phase III MPACT trial, nab-paclitaxel plus gemcitabine (nab-P + Gem) demonstrated superior efficacy versus Gem alone for patients with metastatic pancreatic cancer. We sought to examine the feasibility of positron emission tomography (PET) and to compare metabolic response rates and associated correlations with efficacy in the MPACT trial.</AbstractText>
<AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS">Patients with previously untreated metastatic adenocarcinoma of the pancreas were randomized 1:1 to receive nab-P + Gem or Gem alone. Treatment continued until disease progression by RECIST or unacceptable toxicity.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">PET scans were carried out on the first 257 patients enrolled at PET-equipped centers (PET cohort). Most patients (252 of 257) had ≥2 PET-avid lesions, and median maximum standardized uptake values at baseline were 4.6 and 4.5 in the nab-P + Gem and Gem-alone arms, respectively. In a pooled treatment arm analysis, a metabolic response by PET (best response at any time during study) was associated with longer overall survival (OS) (median 11.3 versus 6.9 months; HR, 0.56; P < 0.001). Efficacy results within each treatment arm appeared better for patients with a metabolic response. The metabolic response rate (best response and week 8 response) was higher for nab-P + Gem (best response: 72% versus 53%, P = 0.002; week 8: 67% versus 51%; P = 0.014). Efficacy in the PET cohort was greater for nab-P + Gem versus Gem alone, including for OS (median 10.5 versus 8.4 months; hazard ratio [HR], 0.71; P = 0.009) and ORR by RECIST (31% versus 11%; P < 0.001).</AbstractText>
<AbstractText Label="CONCLUSION" NlmCategory="CONCLUSIONS">Pancreatic lesions were PET avid at baseline, and the rate of metabolic response was significantly higher for nab-P + Gem versus Gem alone at week 8 and for best response during study. Having a metabolic response was associated with longer survival, and more patients experienced a metabolic response than a RECIST-defined response.</AbstractText>
<AbstractText Label="CLINICALTRIALSGOV" NlmCategory="UNASSIGNED">NCT00844649.</AbstractText>
<CopyrightInformation>© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Ramanathan</LastName>
<ForeName>R K</ForeName>
<Initials>RK</Initials>
<AffiliationInfo><Affiliation>Division of Hematology/Oncology, Mayo Clinic, Scottsdale, USA ramanathan.ramesh@mayo.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Goldstein</LastName>
<ForeName>D</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Korn</LastName>
<ForeName>R L</ForeName>
<Initials>RL</Initials>
<AffiliationInfo><Affiliation>Diagnostic Radiology, Scottsdale Medical Imaging, Ltd, Scottsdale.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Arena</LastName>
<ForeName>F</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Hematology/Oncology, NYU Langone Arena Oncology, Lake Success, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Moore</LastName>
<ForeName>M</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Provencial Health Services Authority, BC Cancer Agency, Vancouver, Canada.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Siena</LastName>
<ForeName>S</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Falck Division of Oncology, Department of Oncology and Hematology, Niguarda Cancer Center, Ospedale Niguarda Ca' Granda and Università degli Studi di Millano, Milan, Italy.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Teixeira</LastName>
<ForeName>L</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Department of Medical Oncology, Hôpital Saint-Antoine, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Tabernero</LastName>
<ForeName>J</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Department of Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Van Laethem</LastName>
<ForeName>J-L</ForeName>
<Initials>JL</Initials>
<AffiliationInfo><Affiliation>University Clinic of Brussels, Hôpital Erasme, Brussels, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Liu</LastName>
<ForeName>H</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Biostatistics and Research and Design, Celgene Corporation, Summit.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>McGovern</LastName>
<ForeName>D</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Biostatistics and Research and Design, Celgene Corporation, Summit.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lu</LastName>
<ForeName>B</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Biostatistics and Research and Design, Celgene Corporation, Summit.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Von Hoff</LastName>
<ForeName>D D</ForeName>
<Initials>DD</Initials>
<AffiliationInfo><Affiliation>Clinical Research, Translational Genomics Research Institute and Honor Health, Scottsdale, USA.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT00844649</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
<PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>01</Month>
<Day>22</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Ann Oncol</MedlineTA>
<NlmUniqueID>9007735</NlmUniqueID>
<ISSNLinking>0923-7534</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="C520255">130-nm albumin-bound paclitaxel</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000418">Albumins</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0W860991D6</RegistryNumber>
<NameOfSubstance UI="D003841">Deoxycytidine</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>B76N6SBZ8R</RegistryNumber>
<NameOfSubstance UI="C056507">gemcitabine</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>P88XT4IS4D</RegistryNumber>
<NameOfSubstance UI="D017239">Paclitaxel</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
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</CommentsCorrectionsList>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000230" MajorTopicYN="N">Adenocarcinoma</DescriptorName>
<QualifierName UI="Q000000981" MajorTopicYN="N">diagnostic imaging</QualifierName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName>
</MeshHeading>
<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="D000418" MajorTopicYN="N">Albumins</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D003841" MajorTopicYN="N">Deoxycytidine</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018572" MajorTopicYN="N">Disease-Free Survival</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009362" MajorTopicYN="N">Neoplasm Metastasis</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017239" MajorTopicYN="N">Paclitaxel</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010190" MajorTopicYN="N">Pancreatic Neoplasms</DescriptorName>
<QualifierName UI="Q000000981" MajorTopicYN="N">diagnostic imaging</QualifierName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000473" MajorTopicYN="N">pathology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D049268" MajorTopicYN="N">Positron-Emission Tomography</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<OtherID Source="NLM">PMC4803456</OtherID>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">gemcitabine</Keyword>
<Keyword MajorTopicYN="N">metabolic response</Keyword>
<Keyword MajorTopicYN="N">nab-paclitaxel</Keyword>
<Keyword MajorTopicYN="N">pancreatic cancer</Keyword>
<Keyword MajorTopicYN="N">positron emission tomography</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year>
<Month>11</Month>
<Day>23</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2015</Year>
<Month>12</Month>
<Day>30</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2016</Year>
<Month>1</Month>
<Day>24</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="pubmed"><Year>2016</Year>
<Month>1</Month>
<Day>24</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
<PubMedPubDate PubStatus="medline"><Year>2016</Year>
<Month>12</Month>
<Day>15</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">26802153</ArticleId>
<ArticleId IdType="pii">mdw020</ArticleId>
<ArticleId IdType="doi">10.1093/annonc/mdw020</ArticleId>
<ArticleId IdType="pmc">PMC4803456</ArticleId>
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<affiliations><list><country><li>Australie</li>
<li>Belgique</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Italie</li>
<li>États-Unis</li>
</country>
<region><li>Catalogne</li>
<li>Lombardie</li>
<li>Nouvelle-Galles du Sud</li>
<li>Région de Bruxelles-Capitale</li>
<li>Île-de-France</li>
</region>
<settlement><li>Barcelone</li>
<li>Bruxelles</li>
<li>Milan</li>
<li>Paris</li>
<li>Sydney</li>
</settlement>
</list>
<tree><noCountry><name sortKey="Korn, R L" sort="Korn, R L" uniqKey="Korn R" first="R L" last="Korn">R L Korn</name>
<name sortKey="Liu, H" sort="Liu, H" uniqKey="Liu H" first="H" last="Liu">H. Liu</name>
<name sortKey="Lu, B" sort="Lu, B" uniqKey="Lu B" first="B" last="Lu">B. Lu</name>
<name sortKey="Mcgovern, D" sort="Mcgovern, D" uniqKey="Mcgovern D" first="D" last="Mcgovern">D. Mcgovern</name>
</noCountry>
<country name="États-Unis"><noRegion><name sortKey="Ramanathan, R K" sort="Ramanathan, R K" uniqKey="Ramanathan R" first="R K" last="Ramanathan">R K Ramanathan</name>
</noRegion>
<name sortKey="Arena, F" sort="Arena, F" uniqKey="Arena F" first="F" last="Arena">F. Arena</name>
<name sortKey="Von Hoff, D D" sort="Von Hoff, D D" uniqKey="Von Hoff D" first="D D" last="Von Hoff">D D Von Hoff</name>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Goldstein, D" sort="Goldstein, D" uniqKey="Goldstein D" first="D" last="Goldstein">D. Goldstein</name>
</region>
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<country name="Canada"><noRegion><name sortKey="Moore, M" sort="Moore, M" uniqKey="Moore M" first="M" last="Moore">M. Moore</name>
</noRegion>
</country>
<country name="Italie"><region name="Lombardie"><name sortKey="Siena, S" sort="Siena, S" uniqKey="Siena S" first="S" last="Siena">S. Siena</name>
</region>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Teixeira, L" sort="Teixeira, L" uniqKey="Teixeira L" first="L" last="Teixeira">L. Teixeira</name>
</region>
</country>
<country name="Espagne"><region name="Catalogne"><name sortKey="Tabernero, J" sort="Tabernero, J" uniqKey="Tabernero J" first="J" last="Tabernero">J. Tabernero</name>
</region>
</country>
<country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Van Laethem, J L" sort="Van Laethem, J L" uniqKey="Van Laethem J" first="J-L" last="Van Laethem">J-L Van Laethem</name>
</region>
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