Standard chemotherapy with or without bevacizumab in advanced ovarian cancer: quality-of-life outcomes from the International Collaboration on Ovarian Neoplasms (ICON7) phase 3 randomised trial
Identifieur interne : 004469 ( Main/Exploration ); précédent : 004468; suivant : 004470Standard chemotherapy with or without bevacizumab in advanced ovarian cancer: quality-of-life outcomes from the International Collaboration on Ovarian Neoplasms (ICON7) phase 3 randomised trial
Auteurs : Dan Stark [Royaume-Uni] ; Matthew Nankivell [Royaume-Uni] ; Eric Pujade-Lauraine [France] ; Gunnar Kristensen [Norvège] ; Lorraine Elit [Canada] ; Martin Stockler [Australie] ; Felix Hilpert [Allemagne] ; Andrés Cervantes [Espagne] ; Julia Brown [Royaume-Uni] ; Anne Lanceley [Royaume-Uni] ; Galina Velikova [Royaume-Uni] ; Eduardo Sabate [Suisse] ; Jacobus Pfisterer [Allemagne] ; Mark S. Carey [Canada] ; Philip Beale [Australie] ; Wendi Qian [Royaume-Uni] ; Ann Marie Swart [Royaume-Uni] ; Amit Oza [Canada] ; Tim Perren [Royaume-Uni]Source :
- The Lancet Oncology [ 1470-2045 ] ; 2013.
Abstract
In the Gynecologic Cancer Intergroup International Collaboration on Ovarian Neoplasms 7 (ICON7) trial, bevacizumab improved progression-free survival in patients with ovarian cancer when used in combination with first-line chemotherapy and as a single-drug continuation treatment for 18 cycles. In a preliminary analysis of a high-risk subset of patients, there was also an improvement in overall survival. This study aims to describe the health-related quality-of-life (QoL) outcomes from ICON7.
ICON7 is a randomised, multicentre, open-label phase 3 trial. Between Dec 18, 2006, and Feb 16, 2009, after a surgical procedure aiming to debulk the disease, women with International Federation of Gynecology and Obstetrics (FIGO) high-risk stage I–IV epithelial ovarian cancer were randomly allocated (1:1) by computer program and block randomisation to receive either six cycles of standard chemotherapy (total 18 weeks) with carboplatin (area under the curve 5 or 6) and paclitaxel (175 mg/m2) alone or with bevacizumab (7·5 mg/kg) given intravenously with chemotherapy and continued as a single drug thereafter (total 54 weeks). The primary QoL endpoint was global QoL from the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire–core 30 at week 54, analysed by ANOVA and adjusted for baseline score. Analyses were by intention to treat. The ICON7 trial has completed recruitment and remains in follow-up. This study is registered, number ISRCTN91273375.
764 women were randomly assigned to the standard chemotherapy group and 764 to the bevacizumab group. At baseline, 684 (90%) of women in the standard chemotherapy group and 691 (90%) of those in the bevacizumab group had completed QoL questionnaires. At week 54, 502 (66%) women in the bevacizumab group and 388 (51%) women in the standard chemotherapy group provided QoL data. Overall, the mean global QoL score improved during chemotherapy by 7·2 points (SD 24·4) when analysed for all women with data at baseline and week 18. The mean global QoL score at 54 weeks was higher in the standard chemotherapy group than in the bevacizumab group (76·1 [SD 18·2]
Bevacizumab continuation treatment seems to be associated with a small but clinically significant decrement in QoL compared with standard treatment for women with ovarian cancer. The trade-off between the prolongation of progression-free survival and the quality of that period of time needs to be considered in clinical practice when making treatment decisions.
Roche and the National Institute for Health Research through the UK National Cancer Research Network.
Url:
DOI: 10.1016/S1470-2045(12)70567-3
PubMed: 23333117
PubMed Central: 3596061
Affiliations:
- Allemagne, Australie, Canada, Espagne, France, Norvège, Royaume-Uni, Suisse
- Angleterre, Grand Londres, Nouvelle-Galles du Sud, Ontario, Schleswig-Holstein, Yorkshire-et-Humber, Île-de-France, Østlandet
- Hamilton (Ontario), Kiel, Leeds, Londres, Oslo, Paris, Sydney
- University College de Londres, Université McMaster, Université Paris-Descartes, Université de Leeds, Université de Sydney
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Le document en format XML
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type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Nankivell, Matthew" sort="Nankivell, Matthew" uniqKey="Nankivell M" first="Matthew" last="Nankivell">Matthew Nankivell</name><affiliation wicri:level="3"><nlm:aff id="aff2">Medical Research Council Clinical Trials Unit, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Medical Research Council Clinical Trials Unit, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name><affiliation wicri:level="4"><nlm:aff id="aff3">Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Hôtel-Dieu, Paris, France</nlm:aff><country xml:lang="fr">France</country><wicri:regionArea>Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Hôtel-Dieu, Paris</wicri:regionArea><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author><author><name sortKey="Kristensen, Gunnar" sort="Kristensen, Gunnar" uniqKey="Kristensen G" first="Gunnar" last="Kristensen">Gunnar Kristensen</name><affiliation wicri:level="3"><nlm:aff id="aff4">Department of Gynecologic Oncology and Institute of Medical Informatics, Oslo University Hospital, Oslo, Norway</nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea>Department of Gynecologic Oncology and Institute of Medical Informatics, Oslo University Hospital, Oslo</wicri:regionArea><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Elit, Lorraine" sort="Elit, Lorraine" uniqKey="Elit L" first="Lorraine" last="Elit">Lorraine Elit</name><affiliation wicri:level="4"><nlm:aff id="aff5">Department of Obstetrics and Gynecology, McMaster University, Hamilton, ON, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Obstetrics and Gynecology, McMaster University, Hamilton, ON</wicri:regionArea><orgName type="university">Université McMaster</orgName><placeName><settlement type="city">Hamilton (Ontario)</settlement><region type="state">Ontario</region></placeName></affiliation></author><author><name sortKey="Stockler, Martin" sort="Stockler, Martin" uniqKey="Stockler M" first="Martin" last="Stockler">Martin Stockler</name><affiliation wicri:level="4"><nlm:aff id="aff6">Australia New Zealand Gynaecological Oncology Group, University of Sydney, Camperdown, NSW, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australia New Zealand Gynaecological Oncology Group, University of Sydney, Camperdown, NSW</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation><affiliation wicri:level="4"><nlm:aff id="aff7">National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Camperdown, NSW</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Hilpert, Felix" sort="Hilpert, Felix" uniqKey="Hilpert F" first="Felix" last="Hilpert">Felix Hilpert</name><affiliation wicri:level="3"><nlm:aff id="aff8">Department of Gynecology and Obstetrics, University of Schleswig-Holstein, Kiel, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Gynecology and Obstetrics, University of Schleswig-Holstein, Kiel</wicri:regionArea><placeName><region type="land" nuts="2">Schleswig-Holstein</region><settlement type="city">Kiel</settlement></placeName></affiliation></author><author><name sortKey="Cervantes, Andres" sort="Cervantes, Andres" uniqKey="Cervantes A" first="Andrés" last="Cervantes">Andrés Cervantes</name><affiliation wicri:level="1"><nlm:aff id="aff9">Department of Hematology and Medical Oncology, Institute of Health Research Hospital Clinico, University of Valencia, Valencia, Spain</nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea>Department of Hematology and Medical Oncology, Institute of Health Research Hospital Clinico, University of Valencia, Valencia</wicri:regionArea><wicri:noRegion>Valencia</wicri:noRegion></affiliation></author><author><name sortKey="Brown, Julia" sort="Brown, Julia" uniqKey="Brown J" first="Julia" last="Brown">Julia Brown</name><affiliation wicri:level="4"><nlm:aff id="aff1">Leeds Institute of Molecular Medicine, University of Leeds, St James's Institute of Oncology, Leeds, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Institute of Molecular Medicine, University of Leeds, St James's Institute of Oncology, Leeds</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Lanceley, Anne" sort="Lanceley, Anne" uniqKey="Lanceley A" first="Anne" last="Lanceley">Anne Lanceley</name><affiliation wicri:level="4"><nlm:aff id="aff10">Department of Women's Cancer, Institute for Women's Health, University College London, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Women's Cancer, Institute for Women's Health, University College London, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region><settlement type="city">Londres</settlement></placeName><orgName type="university">University College de Londres</orgName></affiliation></author><author><name sortKey="Velikova, Galina" sort="Velikova, Galina" uniqKey="Velikova G" first="Galina" last="Velikova">Galina Velikova</name><affiliation wicri:level="4"><nlm:aff id="aff1">Leeds Institute of Molecular Medicine, University of Leeds, St James's Institute of Oncology, Leeds, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Leeds Institute of Molecular Medicine, University of Leeds, St James's Institute of Oncology, Leeds</wicri:regionArea><orgName type="university">Université de Leeds</orgName><placeName><settlement type="city">Leeds</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Yorkshire-et-Humber</region></placeName></affiliation></author><author><name sortKey="Sabate, Eduardo" sort="Sabate, Eduardo" uniqKey="Sabate E" first="Eduardo" last="Sabate">Eduardo Sabate</name><affiliation wicri:level="1"><nlm:aff id="aff11">F Hoffmann-La Roche, Basel, Switzerland</nlm:aff><country xml:lang="fr">Suisse</country><wicri:regionArea>F Hoffmann-La Roche, Basel</wicri:regionArea><wicri:noRegion>Basel</wicri:noRegion></affiliation></author><author><name sortKey="Pfisterer, Jacobus" sort="Pfisterer, Jacobus" uniqKey="Pfisterer J" first="Jacobus" last="Pfisterer">Jacobus Pfisterer</name><affiliation wicri:level="1"><nlm:aff id="aff12">Städtisches Klinikum Solingen, Klinik für Gynäkologie und Geburtshilfe, Solingen, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Städtisches Klinikum Solingen, Klinik für Gynäkologie und Geburtshilfe, Solingen</wicri:regionArea><wicri:noRegion>Solingen</wicri:noRegion><wicri:noRegion>Solingen</wicri:noRegion><wicri:noRegion>Solingen</wicri:noRegion></affiliation></author><author><name sortKey="Carey, Mark S" sort="Carey, Mark S" uniqKey="Carey M" first="Mark S" last="Carey">Mark S. Carey</name><affiliation wicri:level="1"><nlm:aff id="aff13">Department of Obstetrics and Gynecology, University of British Columbia, Vancouver, BC, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Department of Obstetrics and Gynecology, University of British Columbia, Vancouver, BC</wicri:regionArea><wicri:noRegion>BC</wicri:noRegion></affiliation></author><author><name sortKey="Beale, Philip" sort="Beale, Philip" uniqKey="Beale P" first="Philip" last="Beale">Philip Beale</name><affiliation wicri:level="4"><nlm:aff id="aff6">Australia New Zealand Gynaecological Oncology Group, University of Sydney, Camperdown, NSW, Australia</nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea>Australia New Zealand Gynaecological Oncology Group, University of Sydney, Camperdown, NSW</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Qian, Wendi" sort="Qian, Wendi" uniqKey="Qian W" first="Wendi" last="Qian">Wendi Qian</name><affiliation wicri:level="1"><nlm:aff id="aff14">Cambridge Cancer Trials Centre, Cambridge, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Cambridge Cancer Trials Centre, Cambridge</wicri:regionArea><wicri:noRegion>Cambridge</wicri:noRegion></affiliation></author><author><name sortKey="Swart, Ann Marie" sort="Swart, Ann Marie" uniqKey="Swart A" first="Ann Marie" last="Swart">Ann Marie Swart</name><affiliation wicri:level="3"><nlm:aff id="aff2">Medical Research Council Clinical Trials Unit, London, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Medical Research Council Clinical Trials Unit, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Oza, Amit" sort="Oza, Amit" uniqKey="Oza A" first="Amit" last="Oza">Amit Oza</name><affiliation wicri:level="1"><nlm:aff id="aff15">Princess Margaret Hospital, Toronto, ON, Canada</nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea>Princess Margaret Hospital, Toronto, ON</wicri:regionArea><wicri:noRegion>ON</wicri:noRegion></affiliation></author><author><name sortKey="Perren, Tim" sort="Perren, Tim" uniqKey="Perren T" first="Tim" last="Perren">Tim Perren</name><affiliation wicri:level="1"><nlm:aff id="aff16">St James's Institute of Oncology, St James's University Hospital, Leeds, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>St James's Institute of Oncology, St James's University Hospital, Leeds</wicri:regionArea><wicri:noRegion>Leeds</wicri:noRegion></affiliation></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><title>Background</title><p>In the Gynecologic Cancer Intergroup International Collaboration on Ovarian Neoplasms 7 (ICON7) trial, bevacizumab improved progression-free survival in patients with ovarian cancer when used in combination with first-line chemotherapy and as a single-drug continuation treatment for 18 cycles. In a preliminary analysis of a high-risk subset of patients, there was also an improvement in overall survival. This study aims to describe the health-related quality-of-life (QoL) outcomes from ICON7.</p></sec><sec><title>Methods</title><p>ICON7 is a randomised, multicentre, open-label phase 3 trial. Between Dec 18, 2006, and Feb 16, 2009, after a surgical procedure aiming to debulk the disease, women with International Federation of Gynecology and Obstetrics (FIGO) high-risk stage I–IV epithelial ovarian cancer were randomly allocated (1:1) by computer program and block randomisation to receive either six cycles of standard chemotherapy (total 18 weeks) with carboplatin (area under the curve 5 or 6) and paclitaxel (175 mg/m<sup>2</sup>) alone or with bevacizumab (7·5 mg/kg) given intravenously with chemotherapy and continued as a single drug thereafter (total 54 weeks). The primary QoL endpoint was global QoL from the European Organisation for Research and Treatment of Cancer quality-of-life questionnaire–core 30 at week 54, analysed by ANOVA and adjusted for baseline score. Analyses were by intention to treat. The ICON7 trial has completed recruitment and remains in follow-up. This study is registered, number ISRCTN91273375.</p></sec><sec><title>Findings</title><p>764 women were randomly assigned to the standard chemotherapy group and 764 to the bevacizumab group. At baseline, 684 (90%) of women in the standard chemotherapy group and 691 (90%) of those in the bevacizumab group had completed QoL questionnaires. At week 54, 502 (66%) women in the bevacizumab group and 388 (51%) women in the standard chemotherapy group provided QoL data. Overall, the mean global QoL score improved during chemotherapy by 7·2 points (SD 24·4) when analysed for all women with data at baseline and week 18. The mean global QoL score at 54 weeks was higher in the standard chemotherapy group than in the bevacizumab group (76·1 [SD 18·2] <italic>vs</italic> 69·7 [19·1] points; difference 6·4 points, 95% CI 3·7–9·0, p<0·0001).</p></sec><sec><title>Interpretation</title><p>Bevacizumab continuation treatment seems to be associated with a small but clinically significant decrement in QoL compared with standard treatment for women with ovarian cancer. The trade-off between the prolongation of progression-free survival and the quality of that period of time needs to be considered in clinical practice when making treatment decisions.</p></sec><sec><title>Funding</title><p>Roche and the National Institute for Health Research through the UK National Cancer Research Network.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Yoneda, J" uniqKey="Yoneda J">J Yoneda</name></author><author><name sortKey="Kuniyasu, H" uniqKey="Kuniyasu H">H Kuniyasu</name></author><author><name sortKey="Crispens, Ma" uniqKey="Crispens M">MA Crispens</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Huang, S" uniqKey="Huang S">S Huang</name></author><author><name sortKey="Robinson, Jb" uniqKey="Robinson J">JB Robinson</name></author><author><name sortKey="Deguzman, A" uniqKey="Deguzman A">A 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Escudier</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>Espagne</li><li>France</li><li>Norvège</li><li>Royaume-Uni</li><li>Suisse</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Nouvelle-Galles du Sud</li><li>Ontario</li><li>Schleswig-Holstein</li><li>Yorkshire-et-Humber</li><li>Île-de-France</li><li>Østlandet</li></region><settlement><li>Hamilton (Ontario)</li><li>Kiel</li><li>Leeds</li><li>Londres</li><li>Oslo</li><li>Paris</li><li>Sydney</li></settlement><orgName><li>University College de Londres</li><li>Université McMaster</li><li>Université Paris-Descartes</li><li>Université de Leeds</li><li>Université de Sydney</li></orgName></list><tree><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Stark, Dan" sort="Stark, Dan" uniqKey="Stark D" first="Dan" last="Stark">Dan Stark</name></region><name sortKey="Brown, Julia" sort="Brown, Julia" uniqKey="Brown J" first="Julia" last="Brown">Julia Brown</name><name sortKey="Lanceley, Anne" sort="Lanceley, Anne" uniqKey="Lanceley A" first="Anne" last="Lanceley">Anne Lanceley</name><name sortKey="Nankivell, Matthew" sort="Nankivell, Matthew" uniqKey="Nankivell M" first="Matthew" last="Nankivell">Matthew Nankivell</name><name sortKey="Perren, Tim" sort="Perren, Tim" uniqKey="Perren T" first="Tim" last="Perren">Tim Perren</name><name sortKey="Qian, Wendi" sort="Qian, Wendi" uniqKey="Qian W" first="Wendi" last="Qian">Wendi Qian</name><name sortKey="Swart, Ann Marie" sort="Swart, Ann Marie" uniqKey="Swart A" first="Ann Marie" last="Swart">Ann Marie Swart</name><name sortKey="Velikova, Galina" sort="Velikova, Galina" uniqKey="Velikova G" first="Galina" last="Velikova">Galina Velikova</name></country><country name="France"><region name="Île-de-France"><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name></region></country><country name="Norvège"><region name="Østlandet"><name sortKey="Kristensen, Gunnar" sort="Kristensen, Gunnar" uniqKey="Kristensen G" first="Gunnar" last="Kristensen">Gunnar Kristensen</name></region></country><country name="Canada"><region name="Ontario"><name sortKey="Elit, Lorraine" sort="Elit, Lorraine" uniqKey="Elit L" first="Lorraine" last="Elit">Lorraine Elit</name></region><name sortKey="Carey, Mark S" sort="Carey, Mark S" uniqKey="Carey M" first="Mark S" last="Carey">Mark S. Carey</name><name sortKey="Oza, Amit" sort="Oza, Amit" uniqKey="Oza A" first="Amit" last="Oza">Amit Oza</name></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Stockler, Martin" sort="Stockler, Martin" uniqKey="Stockler M" first="Martin" last="Stockler">Martin Stockler</name></region><name sortKey="Beale, Philip" sort="Beale, Philip" uniqKey="Beale P" first="Philip" last="Beale">Philip Beale</name><name sortKey="Stockler, Martin" sort="Stockler, Martin" uniqKey="Stockler M" first="Martin" last="Stockler">Martin Stockler</name></country><country name="Allemagne"><region name="Schleswig-Holstein"><name sortKey="Hilpert, Felix" sort="Hilpert, Felix" uniqKey="Hilpert F" first="Felix" last="Hilpert">Felix Hilpert</name></region><name sortKey="Pfisterer, Jacobus" sort="Pfisterer, Jacobus" uniqKey="Pfisterer J" first="Jacobus" last="Pfisterer">Jacobus Pfisterer</name></country><country name="Espagne"><noRegion><name sortKey="Cervantes, Andres" sort="Cervantes, Andres" uniqKey="Cervantes A" first="Andrés" last="Cervantes">Andrés Cervantes</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Sabate, Eduardo" sort="Sabate, Eduardo" uniqKey="Sabate E" first="Eduardo" last="Sabate">Eduardo Sabate</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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