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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti–IL-6) in multiple myeloma</title><author><name sortKey="San Miguel, Jesus" sort="San Miguel, Jesus" uniqKey="San Miguel J" first="Jesús" last="San-Miguel">Jesús San-Miguel</name><affiliation><nlm:aff id="aff1">Centro de Investigación Medica Aplicada, Clinica Universidad de Navarra, Navarra, Spain;</nlm:aff></affiliation></author><author><name sortKey="Blade, Joan" sort="Blade, Joan" uniqKey="Blade J" first="Joan" last="Bladé">Joan Bladé</name><affiliation><nlm:aff id="aff2">Institut d’Investigacions Biomediques August Pi I Sunyer, Hospital Clinic I Provincial, Barcelona, Spain;</nlm:aff></affiliation></author><author><name sortKey="Shpilberg, Ofer" sort="Shpilberg, Ofer" uniqKey="Shpilberg O" first="Ofer" last="Shpilberg">Ofer Shpilberg</name><affiliation><nlm:aff id="aff3">Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel;</nlm:aff></affiliation></author><author><name sortKey="Grosicki, Sebastian" sort="Grosicki, Sebastian" uniqKey="Grosicki S" first="Sebastian" last="Grosicki">Sebastian Grosicki</name><affiliation><nlm:aff id="aff4">Oddzial Hematologiczny SPZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzow, Poland;</nlm:aff></affiliation></author><author><name sortKey="Maloisel, Frederic" sort="Maloisel, Frederic" uniqKey="Maloisel F" first="Frédéric" last="Maloisel">Frédéric Maloisel</name><affiliation><nlm:aff id="aff5">Clinique Saint Anne, Strasbourg, France;</nlm:aff></affiliation></author><author><name sortKey="Min, Chang Ki" sort="Min, Chang Ki" uniqKey="Min C" first="Chang-Ki" last="Min">Chang-Ki Min</name><affiliation><nlm:aff id="aff6">Seoul St. Mary’s Hospital, Seoul, Republic of Korea;</nlm:aff></affiliation></author><author><name sortKey="Polo Zarzuela, Marta" sort="Polo Zarzuela, Marta" uniqKey="Polo Zarzuela M" first="Marta" last="Polo Zarzuela">Marta Polo Zarzuela</name><affiliation><nlm:aff id="aff7">Hospital Clinico San Carlos, Madrid, Spain;</nlm:aff></affiliation></author><author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><affiliation><nlm:aff id="aff8">Medical University of Lodz, Lodz, Poland;</nlm:aff></affiliation></author><author><name sortKey="Prasad, Sripada V S S" sort="Prasad, Sripada V S S" uniqKey="Prasad S" first="Sripada V. S. S." last="Prasad">Sripada V. S. S. Prasad</name><affiliation><nlm:aff id="aff9">Apollo Hospitals & Research Foundation, Hyderabad, India;</nlm:aff></affiliation></author><author><name sortKey="Tee Goh, Yeow" sort="Tee Goh, Yeow" uniqKey="Tee Goh Y" first="Yeow" last="Tee Goh">Yeow Tee Goh</name><affiliation><nlm:aff id="aff10">Singapore General Hospital, Singapore, Singapore;</nlm:aff></affiliation></author><author><name sortKey="Laubach, Jacob" sort="Laubach, Jacob" uniqKey="Laubach J" first="Jacob" last="Laubach">Jacob Laubach</name><affiliation><nlm:aff id="aff11">Dana Farber Cancer Institute, Boston, MA;</nlm:aff></affiliation></author><author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name><affiliation><nlm:aff id="aff12">Alfred Health-Monash University, Melbourne, Australia;</nlm:aff></affiliation></author><author><name sortKey="Mateos, Maria Victoria" sort="Mateos, Maria Victoria" uniqKey="Mateos M" first="María-Victoria" last="Mateos">María-Victoria Mateos</name><affiliation><nlm:aff id="aff13">Hospital Universitario Salamanca, Salamanca, Spain;</nlm:aff></affiliation></author><author><name sortKey="Palumbo, Antonio" sort="Palumbo, Antonio" uniqKey="Palumbo A" first="Antonio" last="Palumbo">Antonio Palumbo</name><affiliation><nlm:aff id="aff14">Ospedale Le Molinette, Torino, Italy;</nlm:aff></affiliation></author><author><name sortKey="Puchalski, Tom" sort="Puchalski, Tom" uniqKey="Puchalski T" first="Tom" last="Puchalski">Tom Puchalski</name><affiliation><nlm:aff id="aff15">Janssen Research & Development, Spring House, PA;</nlm:aff></affiliation></author><author><name sortKey="Reddy, Manjula" sort="Reddy, Manjula" uniqKey="Reddy M" first="Manjula" last="Reddy">Manjula Reddy</name><affiliation><nlm:aff id="aff15">Janssen Research & Development, Spring House, PA;</nlm:aff></affiliation></author><author><name sortKey="Uhlar, Clarissa" sort="Uhlar, Clarissa" uniqKey="Uhlar C" first="Clarissa" last="Uhlar">Clarissa Uhlar</name><affiliation><nlm:aff id="aff15">Janssen Research & Development, Spring House, PA;</nlm:aff></affiliation></author><author><name sortKey="Qin, Xiang" sort="Qin, Xiang" uniqKey="Qin X" first="Xiang" last="Qin">Xiang Qin</name><affiliation><nlm:aff id="aff15">Janssen Research & Development, Spring House, PA;</nlm:aff></affiliation></author><author><name sortKey="Van De Velde, Helgi" sort="Van De Velde, Helgi" uniqKey="Van De Velde H" first="Helgi" last="Van De Velde">Helgi Van De Velde</name><affiliation><nlm:aff wicri:cut="; and" id="aff16">Janssen Research & Development, Beerse, Belgium</nlm:aff></affiliation></author><author><name sortKey="Xie, Hong" sort="Xie, Hong" uniqKey="Xie H" first="Hong" last="Xie">Hong Xie</name><affiliation><nlm:aff id="aff15">Janssen Research & Development, Spring House, PA;</nlm:aff></affiliation></author><author><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name><affiliation><nlm:aff id="aff17">The University of Texas MD Anderson Cancer Center, Houston, TX</nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24833354</idno><idno type="pmc">4123433</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4123433</idno><idno type="RBID">PMC:4123433</idno><idno type="doi">10.1182/blood-2013-12-546374</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">001802</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">001802</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti–IL-6) in multiple myeloma</title><author><name sortKey="San Miguel, Jesus" sort="San Miguel, Jesus" uniqKey="San Miguel J" first="Jesús" last="San-Miguel">Jesús San-Miguel</name><affiliation><nlm:aff id="aff1">Centro de Investigación Medica Aplicada, Clinica Universidad de Navarra, Navarra, Spain;</nlm:aff></affiliation></author><author><name sortKey="Blade, Joan" sort="Blade, Joan" uniqKey="Blade J" first="Joan" last="Bladé">Joan Bladé</name><affiliation><nlm:aff id="aff2">Institut d’Investigacions Biomediques August Pi I Sunyer, Hospital Clinic I Provincial, Barcelona, Spain;</nlm:aff></affiliation></author><author><name sortKey="Shpilberg, Ofer" sort="Shpilberg, Ofer" uniqKey="Shpilberg O" first="Ofer" last="Shpilberg">Ofer Shpilberg</name><affiliation><nlm:aff id="aff3">Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel;</nlm:aff></affiliation></author><author><name sortKey="Grosicki, Sebastian" sort="Grosicki, Sebastian" uniqKey="Grosicki S" first="Sebastian" last="Grosicki">Sebastian Grosicki</name><affiliation><nlm:aff id="aff4">Oddzial Hematologiczny SPZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzow, Poland;</nlm:aff></affiliation></author><author><name sortKey="Maloisel, Frederic" sort="Maloisel, Frederic" uniqKey="Maloisel F" first="Frédéric" last="Maloisel">Frédéric Maloisel</name><affiliation><nlm:aff id="aff5">Clinique Saint Anne, Strasbourg, France;</nlm:aff></affiliation></author><author><name sortKey="Min, Chang Ki" sort="Min, Chang Ki" uniqKey="Min C" first="Chang-Ki" last="Min">Chang-Ki Min</name><affiliation><nlm:aff id="aff6">Seoul St. Mary’s Hospital, Seoul, Republic of Korea;</nlm:aff></affiliation></author><author><name sortKey="Polo Zarzuela, Marta" sort="Polo Zarzuela, Marta" uniqKey="Polo Zarzuela M" first="Marta" last="Polo Zarzuela">Marta Polo Zarzuela</name><affiliation><nlm:aff id="aff7">Hospital Clinico San Carlos, Madrid, Spain;</nlm:aff></affiliation></author><author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><affiliation><nlm:aff id="aff8">Medical University of Lodz, Lodz, Poland;</nlm:aff></affiliation></author><author><name sortKey="Prasad, Sripada V S S" sort="Prasad, Sripada V S S" uniqKey="Prasad S" first="Sripada V. S. S." last="Prasad">Sripada V. S. S. Prasad</name><affiliation><nlm:aff id="aff9">Apollo Hospitals & Research Foundation, Hyderabad, India;</nlm:aff></affiliation></author><author><name sortKey="Tee Goh, Yeow" sort="Tee Goh, Yeow" uniqKey="Tee Goh Y" first="Yeow" last="Tee Goh">Yeow Tee Goh</name><affiliation><nlm:aff id="aff10">Singapore General Hospital, Singapore, Singapore;</nlm:aff></affiliation></author><author><name sortKey="Laubach, Jacob" sort="Laubach, Jacob" uniqKey="Laubach J" first="Jacob" last="Laubach">Jacob Laubach</name><affiliation><nlm:aff id="aff11">Dana Farber Cancer Institute, Boston, MA;</nlm:aff></affiliation></author><author><name sortKey="Spencer, Andrew" sort="Spencer, Andrew" uniqKey="Spencer A" first="Andrew" last="Spencer">Andrew Spencer</name><affiliation><nlm:aff id="aff12">Alfred Health-Monash University, Melbourne, Australia;</nlm:aff></affiliation></author><author><name sortKey="Mateos, Maria Victoria" sort="Mateos, Maria Victoria" uniqKey="Mateos M" first="María-Victoria" last="Mateos">María-Victoria Mateos</name><affiliation><nlm:aff id="aff13">Hospital Universitario Salamanca, Salamanca, Spain;</nlm:aff></affiliation></author><author><name sortKey="Palumbo, Antonio" sort="Palumbo, Antonio" uniqKey="Palumbo A" first="Antonio" last="Palumbo">Antonio Palumbo</name><affiliation><nlm:aff id="aff14">Ospedale Le Molinette, Torino, Italy;</nlm:aff></affiliation></author><author><name sortKey="Puchalski, Tom" sort="Puchalski, Tom" uniqKey="Puchalski T" first="Tom" last="Puchalski">Tom Puchalski</name><affiliation><nlm:aff id="aff15">Janssen Research & Development, Spring House, PA;</nlm:aff></affiliation></author><author><name sortKey="Reddy, Manjula" sort="Reddy, Manjula" uniqKey="Reddy M" first="Manjula" last="Reddy">Manjula Reddy</name><affiliation><nlm:aff id="aff15">Janssen Research & Development, Spring House, PA;</nlm:aff></affiliation></author><author><name sortKey="Uhlar, Clarissa" sort="Uhlar, Clarissa" uniqKey="Uhlar C" first="Clarissa" last="Uhlar">Clarissa Uhlar</name><affiliation><nlm:aff id="aff15">Janssen Research & Development, Spring House, PA;</nlm:aff></affiliation></author><author><name sortKey="Qin, Xiang" sort="Qin, Xiang" uniqKey="Qin X" first="Xiang" last="Qin">Xiang Qin</name><affiliation><nlm:aff id="aff15">Janssen Research & Development, Spring House, PA;</nlm:aff></affiliation></author><author><name sortKey="Van De Velde, Helgi" sort="Van De Velde, Helgi" uniqKey="Van De Velde H" first="Helgi" last="Van De Velde">Helgi Van De Velde</name><affiliation><nlm:aff wicri:cut="; and" id="aff16">Janssen Research & Development, Beerse, Belgium</nlm:aff></affiliation></author><author><name sortKey="Xie, Hong" sort="Xie, Hong" uniqKey="Xie H" first="Hong" last="Xie">Hong Xie</name><affiliation><nlm:aff id="aff15">Janssen Research & Development, Spring House, PA;</nlm:aff></affiliation></author><author><name sortKey="Orlowski, Robert Z" sort="Orlowski, Robert Z" uniqKey="Orlowski R" first="Robert Z." last="Orlowski">Robert Z. Orlowski</name><affiliation><nlm:aff id="aff17">The University of Texas MD Anderson Cancer Center, Houston, TX</nlm:aff></affiliation></author></analytic><series><title level="j">Blood</title><idno type="ISSN">0006-4971</idno><idno type="eISSN">1528-0020</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><title>Key Points</title><p><list list-type="bullet"><list-item><p>Adding siltuximab to VMP did not improve CR, progression-free survival, or overall survival but improved very good partial response in MM.</p></list-item><list-item><p>This suggests that the association of less than CR with long-term outcomes and the role of IL-6 in MM should be reassessed.</p></list-item></list></p></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>
<front><journal-meta><journal-id journal-id-type="nlm-ta">Blood</journal-id><journal-id journal-id-type="iso-abbrev">Blood</journal-id><journal-id journal-id-type="hwp">bloodjournal</journal-id><journal-id journal-id-type="pmc">blood</journal-id><journal-id journal-id-type="publisher-id">Blood</journal-id><journal-title-group><journal-title>Blood</journal-title></journal-title-group><issn pub-type="ppub">0006-4971</issn><issn pub-type="epub">1528-0020</issn><publisher><publisher-name>American Society of Hematology</publisher-name><publisher-loc>Washington, DC</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24833354</article-id><article-id pub-id-type="pmc">4123433</article-id><article-id pub-id-type="publisher-id">2013/546374</article-id><article-id pub-id-type="doi">10.1182/blood-2013-12-546374</article-id><article-categories><subj-group subj-group-type="hwp-journal-coll"><subject>29</subject><subject>8</subject><subject>39</subject><subject>102</subject></subj-group><subj-group subj-group-type="heading"><subject>Clinical Trials and Observations</subject></subj-group></article-categories><title-group><article-title>Phase 2 randomized study of bortezomib-melphalan-prednisone with or without siltuximab (anti–IL-6) in multiple myeloma</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>San-Miguel</surname><given-names>Jesús</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Bladé</surname><given-names>Joan</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Shpilberg</surname><given-names>Ofer</given-names></name><xref ref-type="aff" rid="aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Grosicki</surname><given-names>Sebastian</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Maloisel</surname><given-names>Frédéric</given-names></name><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Min</surname><given-names>Chang-Ki</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Polo Zarzuela</surname><given-names>Marta</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Robak</surname><given-names>Tadeusz</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Prasad</surname><given-names>Sripada V. S. S.</given-names></name><xref ref-type="aff" rid="aff9">9</xref></contrib><contrib contrib-type="author"><name><surname>Tee Goh</surname><given-names>Yeow</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Laubach</surname><given-names>Jacob</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Spencer</surname><given-names>Andrew</given-names></name><xref ref-type="aff" rid="aff12">12</xref></contrib><contrib contrib-type="author"><name><surname>Mateos</surname><given-names>María-Victoria</given-names></name><xref ref-type="aff" rid="aff13">13</xref></contrib><contrib contrib-type="author"><name><surname>Palumbo</surname><given-names>Antonio</given-names></name><xref ref-type="aff" rid="aff14">14</xref></contrib><contrib contrib-type="author"><name><surname>Puchalski</surname><given-names>Tom</given-names></name><xref ref-type="aff" rid="aff15">15</xref></contrib><contrib contrib-type="author"><name><surname>Reddy</surname><given-names>Manjula</given-names></name><xref ref-type="aff" rid="aff15">15</xref></contrib><contrib contrib-type="author"><name><surname>Uhlar</surname><given-names>Clarissa</given-names></name><xref ref-type="aff" rid="aff15">15</xref></contrib><contrib contrib-type="author"><name><surname>Qin</surname><given-names>Xiang</given-names></name><xref ref-type="aff" rid="aff15">15</xref></contrib><contrib contrib-type="author"><name><surname>van de Velde</surname><given-names>Helgi</given-names></name><xref ref-type="aff" rid="aff16">16</xref></contrib><contrib contrib-type="author"><name><surname>Xie</surname><given-names>Hong</given-names></name><xref ref-type="aff" rid="aff15">15</xref></contrib><contrib contrib-type="author"><name><surname>Orlowski</surname><given-names>Robert Z.</given-names></name><xref ref-type="aff" rid="aff17">17</xref></contrib><aff id="aff1"><label>1</label>Centro de Investigación Medica Aplicada, Clinica Universidad de Navarra, Navarra, Spain;</aff><aff id="aff2"><label>2</label>Institut d’Investigacions Biomediques August Pi I Sunyer, Hospital Clinic I Provincial, Barcelona, Spain;</aff><aff id="aff3"><label>3</label>Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel;</aff><aff id="aff4"><label>4</label>Oddzial Hematologiczny SPZOZ Zespol Szpitali Miejskich w Chorzowie, Chorzow, Poland;</aff><aff id="aff5"><label>5</label>Clinique Saint Anne, Strasbourg, France;</aff><aff id="aff6"><label>6</label>Seoul St. Mary’s Hospital, Seoul, Republic of Korea;</aff><aff id="aff7"><label>7</label>Hospital Clinico San Carlos, Madrid, Spain;</aff><aff id="aff8"><label>8</label>Medical University of Lodz, Lodz, Poland;</aff><aff id="aff9"><label>9</label>Apollo Hospitals & Research Foundation, Hyderabad, India;</aff><aff id="aff10"><label>10</label>Singapore General Hospital, Singapore, Singapore;</aff><aff id="aff11"><label>11</label>Dana Farber Cancer Institute, Boston, MA;</aff><aff id="aff12"><label>12</label>Alfred Health-Monash University, Melbourne, Australia;</aff><aff id="aff13"><label>13</label>Hospital Universitario Salamanca, Salamanca, Spain;</aff><aff id="aff14"><label>14</label>Ospedale Le Molinette, Torino, Italy;</aff><aff id="aff15"><label>15</label>Janssen Research & Development, Spring House, PA;</aff><aff id="aff16"><label>16</label>Janssen Research & Development, Beerse, Belgium; and</aff><aff id="aff17"><label>17</label>The University of Texas MD Anderson Cancer Center, Houston, TX</aff></contrib-group><pub-date pub-type="ppub"><day>26</day><month>6</month><year>2014</year></pub-date><pub-date pub-type="epreprint"><day>15</day><month>5</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>26</day><month>6</month><year>2015</year></pub-date><pmc-comment> PMC Release delay is 12 months and 0 days and was based on the
<volume>123</volume><issue>26</issue><fpage>4136</fpage><lpage>4142</lpage><history><date date-type="received"><day>23</day><month>12</month><year>2013</year></date><date date-type="accepted"><day>29</day><month>3</month><year>2014</year></date></history><permissions><copyright-statement>© 2014 by The American Society of Hematology</copyright-statement><copyright-year>2014</copyright-year></permissions><self-uri xlink:title="pdf" xlink:type="simple" xlink:href="4136.pdf"></self-uri><abstract abstract-type="executive-summary"><title>Key Points</title><p><list list-type="bullet"><list-item><p>Adding siltuximab to VMP did not improve CR, progression-free survival, or overall survival but improved very good partial response in MM.</p></list-item><list-item><p>This suggests that the association of less than CR with long-term outcomes and the role of IL-6 in MM should be reassessed.</p></list-item></list></p></abstract><abstract><p>Because interleukin-6 (IL-6) is considered important in the proliferation of early multiple myeloma (MM), we hypothesized that the addition of the anti-IL-6 monoclonal antibody siltuximab to the bortezomib-melphalan-prednisone (VMP) regimen would improve outcomes in transplant-ineligible patients with newly diagnosed MM. One hundred and six patients were randomized to receive 9 cycles of VMP or VMP plus siltuximab (11 mg/kg every 3 weeks) followed by siltuximab maintenance. Baseline characteristics were well balanced except for immunoglobulin A subtype and 17p deletions. With a complete response (CR) rate of 27% on siltuximab plus VMP (S+VMP) and 22% on VMP, the study did not confirm its hypothesis that the addition of siltuximab would increase the CR rate by at least 10%. Overall response rate was 88% on S+VMP and 80% on VMP, and at least very good partial response rates were 71% and 51% (<italic>P</italic> = .0382), respectively. Median progression-free survival (17 months) and 1-year overall survival (88%) were identical in the 2 arms. Grade ≥3 adverse-event incidence was 92% on S+VMP and 81% on VMP (<italic>P</italic> = .09), with trends toward more hematologic events and infections on S+VMP. Maintenance therapy with siltuximab was well tolerated. In conclusion, the addition of siltuximab to VMP did not improve the CR rate or long-term outcomes. This study was registered at <ext-link ext-link-type="uri" xlink:href="http://clinicaltrials.gov">http://clinicaltrials.gov</ext-link> as #NCT00911859.</p></abstract><counts><page-count count="7"></page-count></counts><custom-meta-group><custom-meta><meta-name>access</meta-name><meta-value>free</meta-value></custom-meta></custom-meta-group></article-meta></front></pmc></record>Pour manipuler ce document sous Unix (Dilib)
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