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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Docetaxel and dasatinib or placebo in men with metastatic castration-resistant prostate cancer (READY): a randomised, double-blind phase 3 trial</title><author><name sortKey="Araujo, John C" sort="Araujo, John C" uniqKey="Araujo J" first="John C" last="Araujo">John C. Araujo</name></author><author><name sortKey="Trudel, Geralyn C" sort="Trudel, Geralyn C" uniqKey="Trudel G" first="Géralyn C" last="Trudel">Géralyn C. Trudel</name></author><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name></author><author><name sortKey="Armstrong, Andrew J" sort="Armstrong, Andrew J" uniqKey="Armstrong A" first="Andrew J" last="Armstrong">Andrew J. Armstrong</name></author><author><name sortKey="Yu, Evan Y" sort="Yu, Evan Y" uniqKey="Yu E" first="Evan Y" last="Yu">Evan Y. Yu</name></author><author><name sortKey="Bellmunt, Joaquim" sort="Bellmunt, Joaquim" uniqKey="Bellmunt J" first="Joaquim" last="Bellmunt">Joaquim Bellmunt</name></author><author><name sortKey="Wilding, George" sort="Wilding, George" uniqKey="Wilding G" first="George" last="Wilding">George Wilding</name></author><author><name sortKey="Mccaffrey, John" sort="Mccaffrey, John" uniqKey="Mccaffrey J" first="John" last="Mccaffrey">John Mccaffrey</name></author><author><name sortKey="Serrano, Sergio V" sort="Serrano, Sergio V" uniqKey="Serrano S" first="Sergio V" last="Serrano">Sergio V. Serrano</name></author><author><name sortKey="Matveev, Vsevolod B" sort="Matveev, Vsevolod B" uniqKey="Matveev V" first="Vsevolod B" last="Matveev">Vsevolod B. Matveev</name></author><author><name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name></author><author><name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stephane" last="Oudard">Stephane Oudard</name></author><author><name sortKey="Morris, Michael J" sort="Morris, Michael J" uniqKey="Morris M" first="Michael J" last="Morris">Michael J. Morris</name></author><author><name sortKey="Sizer, Bruce" sort="Sizer, Bruce" uniqKey="Sizer B" first="Bruce" last="Sizer">Bruce Sizer</name></author><author><name sortKey="Goebell, Peter J" sort="Goebell, Peter J" uniqKey="Goebell P" first="Peter J" last="Goebell">Peter J. Goebell</name></author><author><name sortKey="Heidenreich, Axel" sort="Heidenreich, Axel" uniqKey="Heidenreich A" first="Axel" last="Heidenreich">Axel Heidenreich</name></author><author><name sortKey="De Bono, Johann S" sort="De Bono, Johann S" uniqKey="De Bono J" first="Johann S" last="De Bono">Johann S. De Bono</name></author><author><name sortKey="Begbie, Stephen" sort="Begbie, Stephen" uniqKey="Begbie S" first="Stephen" last="Begbie">Stephen Begbie</name></author><author><name sortKey="Hong, Jun H" sort="Hong, Jun H" uniqKey="Hong J" first="Jun H" last="Hong">Jun H. Hong</name></author><author><name sortKey="Richardet, Eduardo" sort="Richardet, Eduardo" uniqKey="Richardet E" first="Eduardo" last="Richardet">Eduardo Richardet</name></author><author><name sortKey="Gallardo, Enrique" sort="Gallardo, Enrique" uniqKey="Gallardo E" first="Enrique" last="Gallardo">Enrique Gallardo</name></author><author><name sortKey="Paliwal, Prashni" sort="Paliwal, Prashni" uniqKey="Paliwal P" first="Prashni" last="Paliwal">Prashni Paliwal</name></author><author><name sortKey="Durham, Susan" sort="Durham, Susan" uniqKey="Durham S" first="Susan" last="Durham">Susan Durham</name></author><author><name sortKey="Cheng, Shinta" sort="Cheng, Shinta" uniqKey="Cheng S" first="Shinta" last="Cheng">Shinta Cheng</name></author><author><name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J" last="Logothetis">Christopher J. Logothetis</name></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24211163</idno><idno type="pmc">5478530</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5478530</idno><idno type="RBID">PMC:5478530</idno><idno type="doi">10.1016/S1470-2045(13)70479-0</idno><date when="2013">2013</date><idno type="wicri:Area/Pmc/Corpus">001D79</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001D79</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Docetaxel and dasatinib or placebo in men with metastatic castration-resistant prostate cancer (READY): a randomised, double-blind phase 3 trial</title><author><name sortKey="Araujo, John C" sort="Araujo, John C" uniqKey="Araujo J" first="John C" last="Araujo">John C. Araujo</name></author><author><name sortKey="Trudel, Geralyn C" sort="Trudel, Geralyn C" uniqKey="Trudel G" first="Géralyn C" last="Trudel">Géralyn C. Trudel</name></author><author><name sortKey="Saad, Fred" sort="Saad, Fred" uniqKey="Saad F" first="Fred" last="Saad">Fred Saad</name></author><author><name sortKey="Armstrong, Andrew J" sort="Armstrong, Andrew J" uniqKey="Armstrong A" first="Andrew J" last="Armstrong">Andrew J. Armstrong</name></author><author><name sortKey="Yu, Evan Y" sort="Yu, Evan Y" uniqKey="Yu E" first="Evan Y" last="Yu">Evan Y. Yu</name></author><author><name sortKey="Bellmunt, Joaquim" sort="Bellmunt, Joaquim" uniqKey="Bellmunt J" first="Joaquim" last="Bellmunt">Joaquim Bellmunt</name></author><author><name sortKey="Wilding, George" sort="Wilding, George" uniqKey="Wilding G" first="George" last="Wilding">George Wilding</name></author><author><name sortKey="Mccaffrey, John" sort="Mccaffrey, John" uniqKey="Mccaffrey J" first="John" last="Mccaffrey">John Mccaffrey</name></author><author><name sortKey="Serrano, Sergio V" sort="Serrano, Sergio V" uniqKey="Serrano S" first="Sergio V" last="Serrano">Sergio V. Serrano</name></author><author><name sortKey="Matveev, Vsevolod B" sort="Matveev, Vsevolod B" uniqKey="Matveev V" first="Vsevolod B" last="Matveev">Vsevolod B. Matveev</name></author><author><name sortKey="Efstathiou, Eleni" sort="Efstathiou, Eleni" uniqKey="Efstathiou E" first="Eleni" last="Efstathiou">Eleni Efstathiou</name></author><author><name sortKey="Oudard, Stephane" sort="Oudard, Stephane" uniqKey="Oudard S" first="Stephane" last="Oudard">Stephane Oudard</name></author><author><name sortKey="Morris, Michael J" sort="Morris, Michael J" uniqKey="Morris M" first="Michael J" last="Morris">Michael J. Morris</name></author><author><name sortKey="Sizer, Bruce" sort="Sizer, Bruce" uniqKey="Sizer B" first="Bruce" last="Sizer">Bruce Sizer</name></author><author><name sortKey="Goebell, Peter J" sort="Goebell, Peter J" uniqKey="Goebell P" first="Peter J" last="Goebell">Peter J. Goebell</name></author><author><name sortKey="Heidenreich, Axel" sort="Heidenreich, Axel" uniqKey="Heidenreich A" first="Axel" last="Heidenreich">Axel Heidenreich</name></author><author><name sortKey="De Bono, Johann S" sort="De Bono, Johann S" uniqKey="De Bono J" first="Johann S" last="De Bono">Johann S. De Bono</name></author><author><name sortKey="Begbie, Stephen" sort="Begbie, Stephen" uniqKey="Begbie S" first="Stephen" last="Begbie">Stephen Begbie</name></author><author><name sortKey="Hong, Jun H" sort="Hong, Jun H" uniqKey="Hong J" first="Jun H" last="Hong">Jun H. Hong</name></author><author><name sortKey="Richardet, Eduardo" sort="Richardet, Eduardo" uniqKey="Richardet E" first="Eduardo" last="Richardet">Eduardo Richardet</name></author><author><name sortKey="Gallardo, Enrique" sort="Gallardo, Enrique" uniqKey="Gallardo E" first="Enrique" last="Gallardo">Enrique Gallardo</name></author><author><name sortKey="Paliwal, Prashni" sort="Paliwal, Prashni" uniqKey="Paliwal P" first="Prashni" last="Paliwal">Prashni Paliwal</name></author><author><name sortKey="Durham, Susan" sort="Durham, Susan" uniqKey="Durham S" first="Susan" last="Durham">Susan Durham</name></author><author><name sortKey="Cheng, Shinta" sort="Cheng, Shinta" uniqKey="Cheng S" first="Shinta" last="Cheng">Shinta Cheng</name></author><author><name sortKey="Logothetis, Christopher J" sort="Logothetis, Christopher J" uniqKey="Logothetis C" first="Christopher J" last="Logothetis">Christopher J. Logothetis</name></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="ISSN">1470-2045</idno><idno type="eISSN">1474-5488</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Summary</title><sec id="S1"><title>Background</title><p id="P1">Src kinase-mediated interactions between prostate cancer cells and osteoclasts might promote bone metastasis. Dasatinib inhibits tyrosine kinases, including Src kinases. Data suggests that dasatinib kinase inhibition leads to antitumour activity, affects osteoclasts, and has synergy with docetaxel, a first-line chemotherapy for metastatic castration-resistant prostate cancer. We assessed whether dasatinib plus docetaxel in chemotherapy-naive men with metastatic castration-resistant prostate cancer led to greater efficacy than with docetaxel alone.</p></sec><sec id="S2"><title>Methods</title><p id="P2">In this double-blind, randomised, placebo-controlled phase 3 study, we enrolled men of 18 years or older with chemotherapy-naive, metastatic, castration-resistant prostate cancer, and adequate organ function from 186 centres across 25 countries. Eligible patients were randomly assigned (1:1) via an interactive voice response system to receive docetaxel (75 mg/m<sup>2</sup> intravenously every 3 weeks, plus oral prednisone 5 mg twice daily), plus either dasatinib (100 mg orally once daily) or placebo until disease progression or unacceptable toxicity. Randomisation was stratified by Eastern Cooperative Oncology Group performance status (0–1 <italic>vs</italic> 2), bisphosphonate use (yes <italic>vs</italic> no), and urinary N-telopeptide (uNTx) value (<60 μmol/mol creatinine <italic>vs</italic> ≥60 μmol/mol creatinine). All patients, investigators, and personnel involved in study conduct and data analyses were blinded to treatment allocation. The primary endpoint was overall survival, analysed by intention to treat. The trial is registered with <ext-link ext-link-type="uri" xlink:href="ClinicalTrials.gov">ClinicalTrials.gov</ext-link>, number NCT00744497.</p></sec><sec id="S3"><title>Findings</title><p id="P3">Between Oct 30, 2008, and April 11, 2011, 1522 eligible patients were randomly assigned to treatment; 762 patients were assigned to dasatinib and 760 to placebo. At final analysis, median follow-up was 19.0 months (IQR 11.2–25.1) and 914 patients had died. Median overall survival was 21.5 months (95% CI 20.3–22.8) in the dasatinib group and 21.2 months (20.0–23.4) in the placebo group (stratified hazard ratio [HR] 0.99, 95.5% CI 0.87–1.13; p=0.90). The most common grade 3–4 adverse events included diarrhoea (58 [8%] patients in the dasatinib group <italic>vs</italic> 27 [4%] patients in the placebo group), fatigue (62 [8%] <italic>vs</italic> 42 [6%]), and asthenia (40 [5%] <italic>vs</italic> 23 [3%]); grade 3–4 pleural effusions were uncommon (ten [1%] <italic>vs</italic> three [<1%]).</p></sec><sec id="S4"><title>Interpretation</title><p id="P4">The addition of dasatinib to docetaxel did not improve overall survival for chemotherapy-naive men with metastatic castration-resistant prostate cancer. This study does not support the combination of dasatinib and docetaxel in this population of patients.</p></sec><sec id="S5"><title>Funding</title><p id="P5">Bristol-Myers Squibb.</p></sec></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<pmc-dir>properties manuscript</pmc-dir>
<front><journal-meta><journal-id journal-id-type="nlm-journal-id">100957246</journal-id><journal-id journal-id-type="pubmed-jr-id">27004</journal-id><journal-id journal-id-type="nlm-ta">Lancet Oncol</journal-id><journal-id journal-id-type="iso-abbrev">Lancet Oncol.</journal-id><journal-title-group><journal-title>The Lancet. Oncology</journal-title></journal-title-group><issn pub-type="ppub">1470-2045</issn><issn pub-type="epub">1474-5488</issn></journal-meta><article-meta><article-id pub-id-type="pmid">24211163</article-id><article-id pub-id-type="pmc">5478530</article-id><article-id pub-id-type="doi">10.1016/S1470-2045(13)70479-0</article-id><article-id pub-id-type="manuscript">NIHMS860970</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Docetaxel and dasatinib or placebo in men with metastatic castration-resistant prostate cancer (READY): a randomised, double-blind phase 3 trial</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Araujo</surname><given-names>John C</given-names></name><degrees>MD</degrees><aff id="A1">Department of Genitourinary Medical Onology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA</aff></contrib><contrib contrib-type="author"><name><surname>Trudel</surname><given-names>Géralyn C</given-names></name><degrees>PhD</degrees><aff id="A2">Bristol-Myers Squibb, Montreal, QC, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Saad</surname><given-names>Fred</given-names></name><degrees>MD</degrees><role>Prof</role><aff id="A3">Centre Hospitalier de l’Universite de Montreal, Montreal, QC, Canada</aff></contrib><contrib contrib-type="author"><name><surname>Armstrong</surname><given-names>Andrew J</given-names></name><degrees>MD</degrees><aff id="A4">Duke Cancer Institute and the Duke Prostate Center, Duke University, Durham, NC, USA</aff></contrib><contrib contrib-type="author"><name><surname>Yu</surname><given-names>Evan Y</given-names></name><degrees>MD</degrees><aff id="A5">University of Washington and Seattle Cancer Care Alliance, Seattle, WA, USA</aff></contrib><contrib contrib-type="author"><name><surname>Bellmunt</surname><given-names>Joaquim</given-names></name><aff id="A6">University Hospital del Mar-IMIM, Barcelona, Spain (J Bellmunt MD); Dana Farber Cancer Center, Boston, MA, USA</aff></contrib><contrib contrib-type="author"><name><surname>Wilding</surname><given-names>George</given-names></name><degrees>MD</degrees><role>Prof</role><aff id="A7">Carbone Cancer Center, University of Wisconsin, Madison, WI, USA</aff></contrib><contrib contrib-type="author"><name><surname>McCaffrey</surname><given-names>John</given-names></name><degrees>FRCP</degrees><role>Prof</role><aff id="A8">Irish Clinical Oncology Research Group (ICORG), Dublin, Ireland</aff></contrib><contrib contrib-type="author"><name><surname>Serrano</surname><given-names>Sergio V</given-names></name><degrees>MD</degrees><aff id="A9">Hospital Do Cancer de Barretos, São Paulo, Brazil</aff></contrib><contrib contrib-type="author"><name><surname>Matveev</surname><given-names>Vsevolod B</given-names></name><degrees>MD</degrees><role>Prof</role><aff id="A10">N N Blokhin Russian Cancer Research Center, Moscow, Russia</aff></contrib><contrib contrib-type="author"><name><surname>Efstathiou</surname><given-names>Eleni</given-names></name><degrees>MD</degrees><aff id="A11">Department of Clinical Therapeutics, University of Athens, Athens, Greece</aff></contrib><contrib contrib-type="author"><name><surname>Oudard</surname><given-names>Stephane</given-names></name><degrees>MD</degrees><role>Prof</role><aff id="A12">Oncologie Medicale, Hospital European Georges Pompidou, Paris, France</aff></contrib><contrib contrib-type="author"><name><surname>Morris</surname><given-names>Michael J</given-names></name><degrees>MD</degrees><aff id="A13">Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY, USA</aff></contrib><contrib contrib-type="author"><name><surname>Sizer</surname><given-names>Bruce</given-names></name><degrees>MBChB</degrees><aff id="A14">Essex County Hospital, Colchester, Essex, UK</aff></contrib><contrib contrib-type="author"><name><surname>Goebell</surname><given-names>Peter J</given-names></name><degrees>MD</degrees><aff id="A15">Department of Urology and Department of Hematology and Oncology (AURONTE), Friedrich-Alexander-Universitaet, Erlangen, Germany</aff></contrib><contrib contrib-type="author"><name><surname>Heidenreich</surname><given-names>Axel</given-names></name><degrees>MD</degrees><role>Prof</role><aff id="A16">Department of Urology, University Hospital Aachen, Aachen, Germany</aff></contrib><contrib contrib-type="author"><name><surname>de Bono</surname><given-names>Johann S</given-names></name><degrees>MBChB</degrees><role>Prof</role><aff id="A17">Institute of Cancer Research and Royal Marsden Hospital, Sutton, UK</aff></contrib><contrib contrib-type="author"><name><surname>Begbie</surname><given-names>Stephen</given-names></name><degrees>MBBS</degrees><aff id="A18">Port Macquarie Base Hospital, Port Macquarie, NSW, Australia</aff></contrib><contrib contrib-type="author"><name><surname>Hong</surname><given-names>Jun H</given-names></name><degrees>MD</degrees><aff id="A19">Department of Urology, University of Ulsan, Asan Medical Center, Seoul, South Korea</aff></contrib><contrib contrib-type="author"><name><surname>Richardet</surname><given-names>Eduardo</given-names></name><degrees>MD</degrees><aff id="A20">Instituto Oncologico de Cordoba, Universidad Catolico de Cordoba, Cordoba, Argentina</aff></contrib><contrib contrib-type="author"><name><surname>Gallardo</surname><given-names>Enrique</given-names></name><degrees>MD</degrees><aff id="A21">Parc Taulí Sabadell Hospital Universitari, Sabadell, Spain</aff></contrib><contrib contrib-type="author"><name><surname>Paliwal</surname><given-names>Prashni</given-names></name><degrees>PhD</degrees><aff id="A22">Bristol-Myers Squibb, Wallingford, CT, USA</aff></contrib><contrib contrib-type="author"><name><surname>Durham</surname><given-names>Susan</given-names></name><degrees>BA</degrees><aff id="A23">Bristol-Myers Squibb, Wallingford, CT, USA</aff></contrib><contrib contrib-type="author"><name><surname>Cheng</surname><given-names>Shinta</given-names></name><degrees>MD</degrees><aff id="A24">Bristol-Myers Squibb, Lawrenceville, NJ, USA</aff></contrib><contrib contrib-type="author"><name><surname>Logothetis</surname><given-names>Christopher J</given-names></name><degrees>MD</degrees><role>Prof</role><aff id="A25">Department of Genitourinary Medical Onology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA</aff></contrib></contrib-group><author-notes><corresp id="FN1">Correspondence to: Dr John C Araujo, Department of, Genitourinary Medical Oncology, The University of Texas, MD Anderson Cancer Center, Houston, TX, 77030-4004, USA, <email>johna@mdanderson.org</email></corresp></author-notes><pub-date pub-type="nihms-submitted"><day>8</day><month>4</month><year>2017</year></pub-date><pub-date pub-type="epub"><day>08</day><month>11</month><year>2013</year></pub-date><pub-date pub-type="ppub"><month>12</month><year>2013</year></pub-date><pub-date pub-type="pmc-release"><day>21</day><month>6</month><year>2017</year></pub-date><volume>14</volume><issue>13</issue><fpage>1307</fpage><lpage>1316</lpage><pmc-comment>elocation-id from pubmed: 10.1016/S1470-2045(13)70479-0</pmc-comment>
<abstract><title>Summary</title><sec id="S1"><title>Background</title><p id="P1">Src kinase-mediated interactions between prostate cancer cells and osteoclasts might promote bone metastasis. Dasatinib inhibits tyrosine kinases, including Src kinases. Data suggests that dasatinib kinase inhibition leads to antitumour activity, affects osteoclasts, and has synergy with docetaxel, a first-line chemotherapy for metastatic castration-resistant prostate cancer. We assessed whether dasatinib plus docetaxel in chemotherapy-naive men with metastatic castration-resistant prostate cancer led to greater efficacy than with docetaxel alone.</p></sec><sec id="S2"><title>Methods</title><p id="P2">In this double-blind, randomised, placebo-controlled phase 3 study, we enrolled men of 18 years or older with chemotherapy-naive, metastatic, castration-resistant prostate cancer, and adequate organ function from 186 centres across 25 countries. Eligible patients were randomly assigned (1:1) via an interactive voice response system to receive docetaxel (75 mg/m<sup>2</sup> intravenously every 3 weeks, plus oral prednisone 5 mg twice daily), plus either dasatinib (100 mg orally once daily) or placebo until disease progression or unacceptable toxicity. Randomisation was stratified by Eastern Cooperative Oncology Group performance status (0–1 <italic>vs</italic> 2), bisphosphonate use (yes <italic>vs</italic> no), and urinary N-telopeptide (uNTx) value (<60 μmol/mol creatinine <italic>vs</italic> ≥60 μmol/mol creatinine). All patients, investigators, and personnel involved in study conduct and data analyses were blinded to treatment allocation. The primary endpoint was overall survival, analysed by intention to treat. The trial is registered with <ext-link ext-link-type="uri" xlink:href="ClinicalTrials.gov">ClinicalTrials.gov</ext-link>, number NCT00744497.</p></sec><sec id="S3"><title>Findings</title><p id="P3">Between Oct 30, 2008, and April 11, 2011, 1522 eligible patients were randomly assigned to treatment; 762 patients were assigned to dasatinib and 760 to placebo. At final analysis, median follow-up was 19.0 months (IQR 11.2–25.1) and 914 patients had died. Median overall survival was 21.5 months (95% CI 20.3–22.8) in the dasatinib group and 21.2 months (20.0–23.4) in the placebo group (stratified hazard ratio [HR] 0.99, 95.5% CI 0.87–1.13; p=0.90). The most common grade 3–4 adverse events included diarrhoea (58 [8%] patients in the dasatinib group <italic>vs</italic> 27 [4%] patients in the placebo group), fatigue (62 [8%] <italic>vs</italic> 42 [6%]), and asthenia (40 [5%] <italic>vs</italic> 23 [3%]); grade 3–4 pleural effusions were uncommon (ten [1%] <italic>vs</italic> three [<1%]).</p></sec><sec id="S4"><title>Interpretation</title><p id="P4">The addition of dasatinib to docetaxel did not improve overall survival for chemotherapy-naive men with metastatic castration-resistant prostate cancer. This study does not support the combination of dasatinib and docetaxel in this population of patients.</p></sec><sec id="S5"><title>Funding</title><p id="P5">Bristol-Myers Squibb.</p></sec></abstract></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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