Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma.
Identifieur interne : 000480 ( Main/Exploration ); précédent : 000479; suivant : 000481Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma.
Auteurs : RBID : pubmed:22980441Descripteurs français
- Wicri :
- geographic : Pays-Bas.
English descriptors
- KwdEn :
- Adult, Aged, Antibodies, Monoclonal (adverse effects), Antibodies, Monoclonal (metabolism), Antibodies, Monoclonal (therapeutic use), Antigens, Neoplasm (immunology), Carbonic Anhydrases (immunology), Carcinoma, Renal Cell (enzymology), Carcinoma, Renal Cell (immunology), Carcinoma, Renal Cell (radionuclide imaging), Carcinoma, Renal Cell (radiotherapy), Carcinoma, Renal Cell (secondary), Disease Progression, Dose-Response Relationship, Radiation, Female, Humans, Immunoconjugates (adverse effects), Immunoconjugates (metabolism), Immunoconjugates (therapeutic use), Kidney Neoplasms (enzymology), Kidney Neoplasms (immunology), Kidney Neoplasms (pathology), Kidney Neoplasms (radionuclide imaging), Kidney Neoplasms (radiotherapy), Lutetium (adverse effects), Lutetium (metabolism), Lutetium (therapeutic use), Male, Maximum Tolerated Dose, Middle Aged, Netherlands, Radioimmunotherapy (adverse effects), Radiopharmaceuticals (adverse effects), Radiopharmaceuticals (metabolism), Radiopharmaceuticals (therapeutic use), Time Factors, Tissue Distribution, Treatment Outcome, Tumor Burden, Whole Body Imaging.
- MESH :
- chemical , adverse effects : Antibodies, Monoclonal, Immunoconjugates, Lutetium, Radiopharmaceuticals.
- chemical , immunology : Antigens, Neoplasm, Carbonic Anhydrases.
- chemical , metabolism : Antibodies, Monoclonal, Immunoconjugates, Lutetium, Radiopharmaceuticals.
- chemical , therapeutic use : Antibodies, Monoclonal, Immunoconjugates, Lutetium, Radiopharmaceuticals.
- geographic : Netherlands.
- adverse effects : Radioimmunotherapy.
- enzymology : Carcinoma, Renal Cell, Kidney Neoplasms.
- immunology : Carcinoma, Renal Cell, Kidney Neoplasms.
- pathology : Kidney Neoplasms.
- radionuclide imaging : Carcinoma, Renal Cell, Kidney Neoplasms.
- radiotherapy : Carcinoma, Renal Cell, Kidney Neoplasms.
- secondary : Carcinoma, Renal Cell.
- Adult, Aged, Disease Progression, Dose-Response Relationship, Radiation, Female, Humans, Male, Maximum Tolerated Dose, Middle Aged, Time Factors, Tissue Distribution, Treatment Outcome, Tumor Burden, Whole Body Imaging.
Abstract
Patients with metastatic clear cell renal cell carcinoma (ccRCC) have a dismal prognosis. Therefore, new and less toxic treatments are needed.
DOI: 10.1016/j.eururo.2012.08.024
PubMed: 22980441
Links toward previous steps (curation, corpus...)
Le document en format XML
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<author><name sortKey="Stillebroer, Alexander B" uniqKey="Stillebroer A">Alexander B Stillebroer</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. alexanderstillebroer@hotmail.com</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Boerman, Otto C" uniqKey="Boerman O">Otto C Boerman</name>
</author>
<author><name sortKey="Desar, Ingrid M E" uniqKey="Desar I">Ingrid M E Desar</name>
</author>
<author><name sortKey="Boers Sonderen, Marije J" uniqKey="Boers Sonderen M">Marije J Boers-Sonderen</name>
</author>
<author><name sortKey="Van Herpen, Carla M L" uniqKey="Van Herpen C">Carla M L van Herpen</name>
</author>
<author><name sortKey="Langenhuijsen, Johannes F" uniqKey="Langenhuijsen J">Johannes F Langenhuijsen</name>
</author>
<author><name sortKey="Smith Jones, Peter M" uniqKey="Smith Jones P">Peter M Smith-Jones</name>
</author>
<author><name sortKey="Oosterwijk, Egbert" uniqKey="Oosterwijk E">Egbert Oosterwijk</name>
</author>
<author><name sortKey="Oyen, Wim J G" uniqKey="Oyen W">Wim J G Oyen</name>
</author>
<author><name sortKey="Mulders, Peter F A" uniqKey="Mulders P">Peter F A Mulders</name>
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<publicationStmt><date when="2013">2013</date>
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<term>Aged</term>
<term>Antibodies, Monoclonal (adverse effects)</term>
<term>Antibodies, Monoclonal (metabolism)</term>
<term>Antibodies, Monoclonal (therapeutic use)</term>
<term>Antigens, Neoplasm (immunology)</term>
<term>Carbonic Anhydrases (immunology)</term>
<term>Carcinoma, Renal Cell (enzymology)</term>
<term>Carcinoma, Renal Cell (immunology)</term>
<term>Carcinoma, Renal Cell (radionuclide imaging)</term>
<term>Carcinoma, Renal Cell (radiotherapy)</term>
<term>Carcinoma, Renal Cell (secondary)</term>
<term>Disease Progression</term>
<term>Dose-Response Relationship, Radiation</term>
<term>Female</term>
<term>Humans</term>
<term>Immunoconjugates (adverse effects)</term>
<term>Immunoconjugates (metabolism)</term>
<term>Immunoconjugates (therapeutic use)</term>
<term>Kidney Neoplasms (enzymology)</term>
<term>Kidney Neoplasms (immunology)</term>
<term>Kidney Neoplasms (pathology)</term>
<term>Kidney Neoplasms (radionuclide imaging)</term>
<term>Kidney Neoplasms (radiotherapy)</term>
<term>Lutetium (adverse effects)</term>
<term>Lutetium (metabolism)</term>
<term>Lutetium (therapeutic use)</term>
<term>Male</term>
<term>Maximum Tolerated Dose</term>
<term>Middle Aged</term>
<term>Netherlands</term>
<term>Radioimmunotherapy (adverse effects)</term>
<term>Radiopharmaceuticals (adverse effects)</term>
<term>Radiopharmaceuticals (metabolism)</term>
<term>Radiopharmaceuticals (therapeutic use)</term>
<term>Time Factors</term>
<term>Tissue Distribution</term>
<term>Treatment Outcome</term>
<term>Tumor Burden</term>
<term>Whole Body Imaging</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antibodies, Monoclonal</term>
<term>Immunoconjugates</term>
<term>Lutetium</term>
<term>Radiopharmaceuticals</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="immunology" xml:lang="en"><term>Antigens, Neoplasm</term>
<term>Carbonic Anhydrases</term>
</keywords>
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<term>Immunoconjugates</term>
<term>Lutetium</term>
<term>Radiopharmaceuticals</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antibodies, Monoclonal</term>
<term>Immunoconjugates</term>
<term>Lutetium</term>
<term>Radiopharmaceuticals</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en"><term>Netherlands</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Radioimmunotherapy</term>
</keywords>
<keywords scheme="MESH" qualifier="enzymology" xml:lang="en"><term>Carcinoma, Renal Cell</term>
<term>Kidney Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Carcinoma, Renal Cell</term>
<term>Kidney Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Kidney Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="radionuclide imaging" xml:lang="en"><term>Carcinoma, Renal Cell</term>
<term>Kidney Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="radiotherapy" xml:lang="en"><term>Carcinoma, Renal Cell</term>
<term>Kidney Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="secondary" xml:lang="en"><term>Carcinoma, Renal Cell</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Disease Progression</term>
<term>Dose-Response Relationship, Radiation</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Maximum Tolerated Dose</term>
<term>Middle Aged</term>
<term>Time Factors</term>
<term>Tissue Distribution</term>
<term>Treatment Outcome</term>
<term>Tumor Burden</term>
<term>Whole Body Imaging</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Pays-Bas</term>
</keywords>
</textClass>
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<front><div type="abstract" xml:lang="en">Patients with metastatic clear cell renal cell carcinoma (ccRCC) have a dismal prognosis. Therefore, new and less toxic treatments are needed.</div>
</front>
</TEI>
<pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">22980441</PMID>
<DateCreated><Year>2013</Year>
<Month>08</Month>
<Day>06</Day>
</DateCreated>
<DateCompleted><Year>2014</Year>
<Month>03</Month>
<Day>31</Day>
</DateCompleted>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1873-7560</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>64</Volume>
<Issue>3</Issue>
<PubDate><Year>2013</Year>
<Month>Sep</Month>
</PubDate>
</JournalIssue>
<Title>European urology</Title>
<ISOAbbreviation>Eur. Urol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Phase 1 radioimmunotherapy study with lutetium 177-labeled anti-carbonic anhydrase IX monoclonal antibody girentuximab in patients with advanced renal cell carcinoma.</ArticleTitle>
<Pagination><MedlinePgn>478-85</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.eururo.2012.08.024</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0302-2838(12)00959-1</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Patients with metastatic clear cell renal cell carcinoma (ccRCC) have a dismal prognosis. Therefore, new and less toxic treatments are needed.</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">We determined the maximum tolerated dose (MTD) and potential therapeutic efficacy of multiple infusions of lutetium 177 ((177)Lu)-girentuximab (cG250) on various dose levels in a phase 1 trial in patients with progressive metastasized ccRCC.</AbstractText>
<AbstractText Label="DESIGN, SETTING, AND PARTICIPANTS" NlmCategory="METHODS">In this uncontrolled case series in 23 patients with progressive ccRCC metastases, cG250 accumulation was verified by diagnostic indium 111-cG250 imaging. Patients then received a high-activity dose of (177)Lu-cG250.</AbstractText>
<AbstractText Label="INTERVENTION" NlmCategory="METHODS">Groups of three patients received (177)Lu-cG250, starting at a dose level of 1110 MBq/m(2)(177)Lu-cG250, with dose increments of 370 MBq/m(2) per group. In the absence of persistent toxicity, progressive disease, and accelerated blood clearance, patients were eligible for retreatment after 3 mo with 75% of the previous activity dose. Patients could receive a total of three treatment cycles.</AbstractText>
<AbstractText Label="OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS" NlmCategory="METHODS">Determination of the MTD was the primary and therapeutic efficacy was the secondary outcome measurement of the study.</AbstractText>
<AbstractText Label="RESULTS AND LIMITATIONS" NlmCategory="CONCLUSIONS">The MTD was 2405 MBq/m(2) because higher doses resulted in dose-limiting myelotoxicity. Some patients received second (13 of 23 [56%]) and third (4 of 23 [17%]) treatment cycles. Most patients (17 of 23 [74%]) demonstrated stable disease 3 mo after the first treatment, and one patient showed a partial response that lasted for 9 mo. Mean growth of target tumor lesions was reduced from 40.4% (95% confidence interval [CI], ± 17.0) during the last 3 mo before study entry to 5.5% (95% CI, ± 5.3; p<0.001) at 3 mo after the first treatment cycle. No major nonhematologic side effects were observed.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">(177)Lu-cG250 radioimmunotherapy in metastatic ccRCC patients is well tolerated at an activity dose level as high as 2405 MBq/m(2) (MTD). Radioimmunotherapy with (177)Lu-cG250 may stabilize previously progressive metastatic ccRCC.</AbstractText>
<CopyrightInformation>Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Stillebroer</LastName>
<ForeName>Alexander B</ForeName>
<Initials>AB</Initials>
<Affiliation>Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. alexanderstillebroer@hotmail.com</Affiliation>
</Author>
<Author ValidYN="Y"><LastName>Boerman</LastName>
<ForeName>Otto C</ForeName>
<Initials>OC</Initials>
</Author>
<Author ValidYN="Y"><LastName>Desar</LastName>
<ForeName>Ingrid M E</ForeName>
<Initials>IM</Initials>
</Author>
<Author ValidYN="Y"><LastName>Boers-Sonderen</LastName>
<ForeName>Marije J</ForeName>
<Initials>MJ</Initials>
</Author>
<Author ValidYN="Y"><LastName>van Herpen</LastName>
<ForeName>Carla M L</ForeName>
<Initials>CM</Initials>
</Author>
<Author ValidYN="Y"><LastName>Langenhuijsen</LastName>
<ForeName>Johannes F</ForeName>
<Initials>JF</Initials>
</Author>
<Author ValidYN="Y"><LastName>Smith-Jones</LastName>
<ForeName>Peter M</ForeName>
<Initials>PM</Initials>
</Author>
<Author ValidYN="Y"><LastName>Oosterwijk</LastName>
<ForeName>Egbert</ForeName>
<Initials>E</Initials>
</Author>
<Author ValidYN="Y"><LastName>Oyen</LastName>
<ForeName>Wim J G</ForeName>
<Initials>WJ</Initials>
</Author>
<Author ValidYN="Y"><LastName>Mulders</LastName>
<ForeName>Peter F A</ForeName>
<Initials>PF</Initials>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT00142415</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<PublicationTypeList><PublicationType>Clinical Trial, Phase I</PublicationType>
<PublicationType>Journal Article</PublicationType>
<PublicationType>Research Support, Non-U.S. Gov't</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2012</Year>
<Month>08</Month>
<Day>21</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>Switzerland</Country>
<MedlineTA>Eur Urol</MedlineTA>
<NlmUniqueID>7512719</NlmUniqueID>
<ISSNLinking>0302-2838</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance>Antibodies, Monoclonal</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance>Antigens, Neoplasm</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance>G250 monoclonal antibody</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance>Immunoconjugates</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance>Radiopharmaceuticals</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>5H0DOZ21UJ</RegistryNumber>
<NameOfSubstance>Lutetium</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>EC 4.2.1.1</RegistryNumber>
<NameOfSubstance>CA9 protein, human</NameOfSubstance>
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<Chemical><RegistryNumber>EC 4.2.1.1</RegistryNumber>
<NameOfSubstance>Carbonic Anhydrases</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Antibodies, Monoclonal</DescriptorName>
<QualifierName MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName MajorTopicYN="N">metabolism</QualifierName>
<QualifierName MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Antigens, Neoplasm</DescriptorName>
<QualifierName MajorTopicYN="Y">immunology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Carbonic Anhydrases</DescriptorName>
<QualifierName MajorTopicYN="Y">immunology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Carcinoma, Renal Cell</DescriptorName>
<QualifierName MajorTopicYN="N">enzymology</QualifierName>
<QualifierName MajorTopicYN="N">immunology</QualifierName>
<QualifierName MajorTopicYN="N">radionuclide imaging</QualifierName>
<QualifierName MajorTopicYN="Y">radiotherapy</QualifierName>
<QualifierName MajorTopicYN="N">secondary</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Disease Progression</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Dose-Response Relationship, Radiation</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Immunoconjugates</DescriptorName>
<QualifierName MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName MajorTopicYN="N">metabolism</QualifierName>
<QualifierName MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Kidney Neoplasms</DescriptorName>
<QualifierName MajorTopicYN="N">enzymology</QualifierName>
<QualifierName MajorTopicYN="N">immunology</QualifierName>
<QualifierName MajorTopicYN="N">pathology</QualifierName>
<QualifierName MajorTopicYN="N">radionuclide imaging</QualifierName>
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<MeshHeading><DescriptorName MajorTopicYN="N">Lutetium</DescriptorName>
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<QualifierName MajorTopicYN="Y">therapeutic use</QualifierName>
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<MeshHeading><DescriptorName MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Maximum Tolerated Dose</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N" Type="Geographic">Netherlands</DescriptorName>
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<MeshHeading><DescriptorName MajorTopicYN="Y">Radioimmunotherapy</DescriptorName>
<QualifierName MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Radiopharmaceuticals</DescriptorName>
<QualifierName MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName MajorTopicYN="N">metabolism</QualifierName>
<QualifierName MajorTopicYN="Y">therapeutic use</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Time Factors</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Tissue Distribution</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Tumor Burden</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName MajorTopicYN="N">Whole Body Imaging</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Lutetium</Keyword>
<Keyword MajorTopicYN="N">Radioimmunotherapy</Keyword>
<Keyword MajorTopicYN="N">Renal cell carcinoma</Keyword>
<Keyword MajorTopicYN="N">cG250</Keyword>
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</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2012</Year>
<Month>5</Month>
<Day>31</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2012</Year>
<Month>8</Month>
<Day>13</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="aheadofprint"><Year>2012</Year>
<Month>8</Month>
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<PubMedPubDate PubStatus="medline"><Year>2014</Year>
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<PublicationStatus>ppublish</PublicationStatus>
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