Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines
Identifieur interne : 008B18 ( Main/Exploration ); précédent : 008B17; suivant : 008B19Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines
Auteurs : Daniel G. Holler [États-Unis, Royaume-Uni, Australie, Belgique, Allemagne, France, Suède, Espagne, Suisse] ; Jim Cassidy ; Stephen J. Clarke ; David Cunningham ; Eric Van Cutsem ; Paulo M. Hoff ; Mace L. Rothenberg ; Leonard B. Saltz ; Hans-Joachim Schmoll ; Carmen Allegra ; Joseph R. Bertino ; Jean-Yves Douillard ; Bengt G. Gustavsson ; Gerard Milano ; Michael O'Connell ; Youcef Rustum ; Josep Tabernero ; Frank Gilberg ; Florin Sirzen ; Chris TwelvesSource :
- Journal of clinical oncology [ 0732-183X ] ; 2008.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Purpose We conducted a retrospective analysis of safety data from randomized, single-agent fluoropyrimidine clinical trials (bolus fluorouracil/leucovorin [FU/LV] and capecitabine) to test the hypothesis that there are regional differences in fluoropyrimidine tolerability. Methods Treatment-related safety data from three phase III clinical studies were analyzed by multivariate analysis: two comparing capecitabine with bolus FU/LV in metastatic colorectal cancer (MCRC) and one comparing capecitabine plus oxaliplatin (XELOX) with bolus FU/LV as adjuvant treatment for colon cancer. The United States (US) was compared with non-US countries (all three studies) and with the rest of the world and East Asia (adjuvant study). Results In the MCRC studies (n = 1,189), more grade 3/4 adverse events (AEs; relative risk [RR], 1.77), dose reductions (RR, 1.72), and discontinuations (RR, 1.83) were reported in US versus non-US patients. Likewise, in the adjuvant colon cancer study (n = 1,864), more grade 3/4 AEs (RR, 1.47) and discontinuations (RR, 2.09) were reported in US versus non-US patients. After further dividing non-US patients into those in East Asia and the rest of the world, differential RRs for related grade 3/4 AEs, grade 4 AEs, and serious AEs were again observed, with East Asian patients having the lowest and US patients the highest RR. Conclusion Regional differences exist in the tolerability profiles of fluoropyrimidines. More treatment-related toxicity was reported in the US compared with the rest of the world for bolus FU/LV and capecitabine in first-line MCRC and adjuvant colon cancer. In the adjuvant setting, a range of fluoropyrimidine tolerability was observed, with East Asian patients having the lowest, and US patients the highest, RR.
Affiliations:
- Allemagne, Australie, Belgique, Espagne, France, Royaume-Uni, Suisse, Suède, États-Unis
- Angleterre, Catalogne, Grand Londres, Nouvelle-Galles du Sud, Pennsylvanie, Provence-Alpes-Côte d'Azur, État de New York
- Barcelone, Londres, Nice, Philadelphie, Sydney
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Gustavsson</name></author><author><name sortKey="Milano, Gerard" sort="Milano, Gerard" uniqKey="Milano G" first="Gerard" last="Milano">Gerard Milano</name></author><author><name sortKey="O Connell, Michael" sort="O Connell, Michael" uniqKey="O Connell M" first="Michael" last="O'Connell">Michael O'Connell</name></author><author><name sortKey="Rustum, Youcef" sort="Rustum, Youcef" uniqKey="Rustum Y" first="Youcef" last="Rustum">Youcef Rustum</name></author><author><name sortKey="Tabernero, Josep" sort="Tabernero, Josep" uniqKey="Tabernero J" first="Josep" last="Tabernero">Josep Tabernero</name></author><author><name sortKey="Gilberg, Frank" sort="Gilberg, Frank" uniqKey="Gilberg F" first="Frank" last="Gilberg">Frank Gilberg</name></author><author><name sortKey="Sirzen, Florin" sort="Sirzen, Florin" uniqKey="Sirzen F" first="Florin" last="Sirzen">Florin Sirzen</name></author><author><name sortKey="Twelves, Chris" sort="Twelves, Chris" uniqKey="Twelves C" first="Chris" last="Twelves">Chris Twelves</name></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">08-0248546</idno><date when="2008">2008</date><idno type="stanalyst">PASCAL 08-0248546 INIST</idno><idno type="RBID">Pascal:08-0248546</idno><idno type="wicri:Area/PascalFrancis/Corpus">003586</idno><idno type="wicri:Area/PascalFrancis/Curation">002A61</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">002F90</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">002F90</idno><idno type="wicri:doubleKey">0732-183X:2008:Holler D:potential:regional:differences</idno><idno type="wicri:Area/Main/Merge">009404</idno><idno type="wicri:Area/Main/Curation">008B18</idno><idno type="wicri:Area/Main/Exploration">008B18</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines</title><author><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name><affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Abramson Cancer Center at the University of Pennsylvania</s1><s2>Philadelphia</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><placeName><settlement type="city">Philadelphie</settlement><region type="state">Pennsylvanie</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>NSABP Foundation</s1><s2>Pittsburgh, PA</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>NSABP Foundation</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>University of Texas, M.D. Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>Houston, TX</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Vanderbilt-lngram Cancer Center</s1><s2>Nashville, TN</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>Vanderbilt-lngram Cancer Center</wicri:noRegion></affiliation><affiliation wicri:level="2"><inist:fA14 i1="05"><s1>Memorial Sloan-Kettering Cancer Center</s1><s2>New York</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Roswell Park Cancer Institute</s1><s2>Buffalo, NY</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>Roswell Park Cancer Institute</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>NCI-Navy Medical Oncology Branch, National Cancer Institute</s1><s2>Bethesda, MD</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>Bethesda, MD</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Cancer Institute of New Jersey</s1><s2>New Brunswick, NJ</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>Cancer Institute of New Jersey</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Glasgow University</s1><s2>Glasgow</s2><s3>GBR</s3></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>Glasgow University</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Royal Marsden Hospital</s1><s2>London</s2><s3>GBR</s3></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="11"><s1>University of Leeds and Bradford NHS Trust</s1><s2>Bradford</s2><s3>GBR</s3></inist:fA14><country>Royaume-Uni</country><wicri:noRegion>University of Leeds and Bradford NHS Trust</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="12"><s1>University of Sydney and Sydney Cancer Centre</s1><s2>Sydney</s2><s3>AUS</s3></inist:fA14><country>Australie</country><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="13"><s1>University Hospital Gasthuisberg</s1><s2>Leuven</s2><s3>BEL</s3></inist:fA14><country>Belgique</country><wicri:noRegion>University Hospital Gasthuisberg</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Martin Luther University</s1><s2>Halle</s2><s3>DEU</s3></inist:fA14><country>Allemagne</country><wicri:noRegion>Halle</wicri:noRegion><wicri:noRegion>Martin Luther University</wicri:noRegion><wicri:noRegion>Martin Luther University</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Centre René Gauducheau</s1><s2>St Herblain</s2><s3>FRA</s3></inist:fA14><country>France</country><wicri:noRegion>St Herblain</wicri:noRegion><wicri:noRegion>Centre René Gauducheau</wicri:noRegion><wicri:noRegion>Centre René Gauducheau</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="16"><s1>Centre Antoine-Lacassagne</s1><s2>Nice</s2><s3>FRA</s3></inist:fA14><country>France</country><placeName><region type="region">Provence-Alpes-Côte d'Azur</region><region type="old region">Provence-Alpes-Côte d'Azur</region><settlement type="city">Nice</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Gothenburg University</s1><s2>Gothenburg</s2><s3>SWE</s3></inist:fA14><country>Suède</country><wicri:noRegion>Gothenburg University</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="18"><s1>Vail d'Hebron University Hospital</s1><s2>Barcelona</s2><s3>ESP</s3></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="19"><s1>F. Hoffmann-La Roche</s1><s2>Basel</s2><s3>CHE</s3></inist:fA14><country>Suisse</country><wicri:noRegion>F. Hoffmann-La Roche</wicri:noRegion></affiliation></author><author><name sortKey="Cassidy, Jim" sort="Cassidy, Jim" uniqKey="Cassidy J" first="Jim" last="Cassidy">Jim Cassidy</name></author><author><name sortKey="Clarke, Stephen J" sort="Clarke, Stephen J" uniqKey="Clarke S" first="Stephen J." last="Clarke">Stephen J. Clarke</name></author><author><name sortKey="Cunningham, David" sort="Cunningham, David" uniqKey="Cunningham D" first="David" last="Cunningham">David Cunningham</name></author><author><name sortKey="Van Cutsem, Eric" sort="Van Cutsem, Eric" uniqKey="Van Cutsem E" first="Eric" last="Van Cutsem">Eric Van Cutsem</name></author><author><name sortKey="Hoff, Paulo M" sort="Hoff, Paulo M" uniqKey="Hoff P" first="Paulo M." last="Hoff">Paulo M. Hoff</name></author><author><name sortKey="Rothenberg, Mace L" sort="Rothenberg, Mace L" uniqKey="Rothenberg M" first="Mace L." last="Rothenberg">Mace L. Rothenberg</name></author><author><name sortKey="Saltz, Leonard B" sort="Saltz, Leonard B" uniqKey="Saltz L" first="Leonard B." last="Saltz">Leonard B. Saltz</name></author><author><name sortKey="Schmoll, Hans Joachim" sort="Schmoll, Hans Joachim" uniqKey="Schmoll H" first="Hans-Joachim" last="Schmoll">Hans-Joachim Schmoll</name></author><author><name sortKey="Allegra, Carmen" sort="Allegra, Carmen" uniqKey="Allegra C" first="Carmen" last="Allegra">Carmen Allegra</name></author><author><name sortKey="Bertino, Joseph R" sort="Bertino, Joseph R" uniqKey="Bertino J" first="Joseph R." last="Bertino">Joseph R. Bertino</name></author><author><name sortKey="Douillard, Jean Yves" sort="Douillard, Jean Yves" uniqKey="Douillard J" first="Jean-Yves" last="Douillard">Jean-Yves Douillard</name></author><author><name sortKey="Gustavsson, Bengt G" sort="Gustavsson, Bengt G" uniqKey="Gustavsson B" first="Bengt G." last="Gustavsson">Bengt G. Gustavsson</name></author><author><name sortKey="Milano, Gerard" sort="Milano, Gerard" uniqKey="Milano G" first="Gerard" last="Milano">Gerard Milano</name></author><author><name sortKey="O Connell, Michael" sort="O Connell, Michael" uniqKey="O Connell M" first="Michael" last="O'Connell">Michael O'Connell</name></author><author><name sortKey="Rustum, Youcef" sort="Rustum, Youcef" uniqKey="Rustum Y" first="Youcef" last="Rustum">Youcef Rustum</name></author><author><name sortKey="Tabernero, Josep" sort="Tabernero, Josep" uniqKey="Tabernero J" first="Josep" last="Tabernero">Josep Tabernero</name></author><author><name sortKey="Gilberg, Frank" sort="Gilberg, Frank" uniqKey="Gilberg F" first="Frank" last="Gilberg">Frank Gilberg</name></author><author><name sortKey="Sirzen, Florin" sort="Sirzen, Florin" uniqKey="Sirzen F" first="Florin" last="Sirzen">Florin Sirzen</name></author><author><name sortKey="Twelves, Chris" sort="Twelves, Chris" uniqKey="Twelves C" first="Chris" last="Twelves">Chris Twelves</name></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2008">2008</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cancerology</term><term>Geographical variation</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Variation géographique</term><term>Cancérologie</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose We conducted a retrospective analysis of safety data from randomized, single-agent fluoropyrimidine clinical trials (bolus fluorouracil/leucovorin [FU/LV] and capecitabine) to test the hypothesis that there are regional differences in fluoropyrimidine tolerability. Methods Treatment-related safety data from three phase III clinical studies were analyzed by multivariate analysis: two comparing capecitabine with bolus FU/LV in metastatic colorectal cancer (MCRC) and one comparing capecitabine plus oxaliplatin (XELOX) with bolus FU/LV as adjuvant treatment for colon cancer. The United States (US) was compared with non-US countries (all three studies) and with the rest of the world and East Asia (adjuvant study). Results In the MCRC studies (n = 1,189), more grade 3/4 adverse events (AEs; relative risk [RR], 1.77), dose reductions (RR, 1.72), and discontinuations (RR, 1.83) were reported in US versus non-US patients. Likewise, in the adjuvant colon cancer study (n = 1,864), more grade 3/4 AEs (RR, 1.47) and discontinuations (RR, 2.09) were reported in US versus non-US patients. After further dividing non-US patients into those in East Asia and the rest of the world, differential RRs for related grade 3/4 AEs, grade 4 AEs, and serious AEs were again observed, with East Asian patients having the lowest and US patients the highest RR. Conclusion Regional differences exist in the tolerability profiles of fluoropyrimidines. More treatment-related toxicity was reported in the US compared with the rest of the world for bolus FU/LV and capecitabine in first-line MCRC and adjuvant colon cancer. In the adjuvant setting, a range of fluoropyrimidine tolerability was observed, with East Asian patients having the lowest, and US patients the highest, RR.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Belgique</li><li>Espagne</li><li>France</li><li>Royaume-Uni</li><li>Suisse</li><li>Suède</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Catalogne</li><li>Grand Londres</li><li>Nouvelle-Galles du Sud</li><li>Pennsylvanie</li><li>Provence-Alpes-Côte d'Azur</li><li>État de New York</li></region><settlement><li>Barcelone</li><li>Londres</li><li>Nice</li><li>Philadelphie</li><li>Sydney</li></settlement></list><tree><noCountry><name sortKey="Allegra, Carmen" sort="Allegra, Carmen" uniqKey="Allegra C" first="Carmen" last="Allegra">Carmen Allegra</name><name sortKey="Bertino, Joseph R" sort="Bertino, Joseph R" uniqKey="Bertino J" first="Joseph R." last="Bertino">Joseph R. Bertino</name><name sortKey="Cassidy, Jim" sort="Cassidy, Jim" uniqKey="Cassidy J" first="Jim" last="Cassidy">Jim Cassidy</name><name sortKey="Clarke, Stephen J" sort="Clarke, Stephen J" uniqKey="Clarke S" first="Stephen J." last="Clarke">Stephen J. Clarke</name><name sortKey="Cunningham, David" sort="Cunningham, David" uniqKey="Cunningham D" first="David" last="Cunningham">David Cunningham</name><name sortKey="Douillard, Jean Yves" sort="Douillard, Jean Yves" uniqKey="Douillard J" first="Jean-Yves" last="Douillard">Jean-Yves Douillard</name><name sortKey="Gilberg, Frank" sort="Gilberg, Frank" uniqKey="Gilberg F" first="Frank" last="Gilberg">Frank Gilberg</name><name sortKey="Gustavsson, Bengt G" sort="Gustavsson, Bengt G" uniqKey="Gustavsson B" first="Bengt G." last="Gustavsson">Bengt G. Gustavsson</name><name sortKey="Hoff, Paulo M" sort="Hoff, Paulo M" uniqKey="Hoff P" first="Paulo M." last="Hoff">Paulo M. Hoff</name><name sortKey="Milano, Gerard" sort="Milano, Gerard" uniqKey="Milano G" first="Gerard" last="Milano">Gerard Milano</name><name sortKey="O Connell, Michael" sort="O Connell, Michael" uniqKey="O Connell M" first="Michael" last="O'Connell">Michael O'Connell</name><name sortKey="Rothenberg, Mace L" sort="Rothenberg, Mace L" uniqKey="Rothenberg M" first="Mace L." last="Rothenberg">Mace L. Rothenberg</name><name sortKey="Rustum, Youcef" sort="Rustum, Youcef" uniqKey="Rustum Y" first="Youcef" last="Rustum">Youcef Rustum</name><name sortKey="Saltz, Leonard B" sort="Saltz, Leonard B" uniqKey="Saltz L" first="Leonard B." last="Saltz">Leonard B. Saltz</name><name sortKey="Schmoll, Hans Joachim" sort="Schmoll, Hans Joachim" uniqKey="Schmoll H" first="Hans-Joachim" last="Schmoll">Hans-Joachim Schmoll</name><name sortKey="Sirzen, Florin" sort="Sirzen, Florin" uniqKey="Sirzen F" first="Florin" last="Sirzen">Florin Sirzen</name><name sortKey="Tabernero, Josep" sort="Tabernero, Josep" uniqKey="Tabernero J" first="Josep" last="Tabernero">Josep Tabernero</name><name sortKey="Twelves, Chris" sort="Twelves, Chris" uniqKey="Twelves C" first="Chris" last="Twelves">Chris Twelves</name><name sortKey="Van Cutsem, Eric" sort="Van Cutsem, Eric" uniqKey="Van Cutsem E" first="Eric" last="Van Cutsem">Eric Van Cutsem</name></noCountry><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></region><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></noRegion><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></region></country><country name="Belgique"><noRegion><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></noRegion></country><country name="Allemagne"><noRegion><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></noRegion></country><country name="France"><noRegion><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></noRegion><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></country><country name="Suède"><noRegion><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></noRegion></country><country name="Espagne"><region name="Catalogne"><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></region></country><country name="Suisse"><noRegion><name sortKey="Holler, Daniel G" sort="Holler, Daniel G" uniqKey="Holler D" first="Daniel G." last="Holler">Daniel G. Holler</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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