Phase III Randomized Trial Comparing the Efficacy of Cediranib As Monotherapy, and in Combination With Lomustine, Versus Lomustine Alone in Patients With Recurrent Glioblastoma
Identifieur interne : 004D46 ( Main/Exploration ); précédent : 004D45; suivant : 004D47Phase III Randomized Trial Comparing the Efficacy of Cediranib As Monotherapy, and in Combination With Lomustine, Versus Lomustine Alone in Patients With Recurrent Glioblastoma
Auteurs : Tracy T. Batchelor [États-Unis] ; Paul Mulholland [Royaume-Uni] ; Bart Neyns [Belgique] ; L. Burt Nabors [États-Unis] ; Mario Campone [France] ; Antje Wick [Allemagne] ; Warren Mason [Canada] ; Tom Mikkelsen [États-Unis] ; Surasak Phuphanich [États-Unis] ; Lynn S. Ashby [États-Unis] ; John Degroot [États-Unis] ; Rao Gattamaneni [Royaume-Uni] ; Lawrence Cher [États-Unis] ; Mark Rosenthal [Australie] ; Franz Payer [Autriche] ; Juliane M. Jürgensmeier [États-Unis] ; Rakesh K. Jain [États-Unis] ; A. Gregory Sorensen [États-Unis] ; John Xu [États-Unis] ; QI LIU [États-Unis] ; Martin Van Den Bent [Pays-Bas]Source :
- Journal of clinical oncology [ 0732-183X ] ; 2013.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Agences internationales, Femelle, Glioblastome (mortalité), Glioblastome (traitement médicamenteux), Humains, Lomustine (administration et posologie), Mâle, Pronostic, Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Quinazolines (administration et posologie), Récidive tumorale locale (mortalité), Récidive tumorale locale (traitement médicamenteux), Taux de survie, Tumeurs du cerveau (mortalité), Tumeurs du cerveau (traitement médicamenteux), Études de suivi.
- MESH :
- administration et posologie : Lomustine, Quinazolines.
- mortalité : Glioblastome, Récidive tumorale locale, Tumeurs du cerveau.
- traitement médicamenteux : Glioblastome, Récidive tumorale locale, Tumeurs du cerveau.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
- Pascal (Inist)
- Adulte d'âge moyen, Agences internationales, Essai clinique phase III, Femelle, Humains, Mâle, Pronostic, Randomisation, Etude comparative, Cédiranib, Efficacité traitement, Association médicamenteuse, Chimiothérapie, Homme, Récidive, Lomustine, Cancérologie, Glioblastome, Antiangiogénique, Anticancéreux, Monothérapie, Taux de survie, Études de suivi.
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Antiangiogenic agent, Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Antineoplastic agent, Brain Neoplasms (drug therapy), Brain Neoplasms (mortality), Cancerology, Cediranib, Chemotherapy, Comparative study, Drug combination, Female, Follow-Up Studies, Glioblastoma, Glioblastoma (drug therapy), Glioblastoma (mortality), Human, Humans, International Agencies, Lomustine, Lomustine (administration & dosage), Male, Middle Aged, Monotherapy, Neoplasm Recurrence, Local (drug therapy), Neoplasm Recurrence, Local (mortality), Phase III trial, Prognosis, Quinazolines (administration & dosage), Randomization, Relapse, Survival Rate, Treatment efficiency.
- MESH :
- chemical , administration & dosage : Lomustine, Quinazolines.
- drug therapy : Brain Neoplasms, Glioblastoma, Neoplasm Recurrence, Local.
- mortality : Brain Neoplasms, Glioblastoma, Neoplasm Recurrence, Local.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Female, Follow-Up Studies, Humans, International Agencies, Male, Middle Aged, Prognosis, Survival Rate.
Abstract
Purpose A randomized, phase III, placebo-controlled, partially blinded clinical trial (REGAL [Recentin in Glioblastoma Alone and With Lomustine]) was conducted to determine the efficacy of cediranib, an oral pan-vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor, either as monotherapy or in combination with lomustine versus lomustine in patients with recurrent glioblastoma. Patients and Methods Patients (N = 325) with recurrent glioblastoma who previously received radiation and temozolomide were randomly assigned 2:2:1 to receive (1) cediranib (30 mg) monotherapy; (2) cediranib (20 mg) plus lomustine (110 mg/m2); (3) lomustine (110 mg/m2) plus a placebo. The primary end point was progression-free survival based on blinded, independent radiographic assessment of postcontrast T1-weighted and noncontrast T2-weighted magnetic resonance imaging (MRI) brain scans. Results The primary end point of progression-free survival (PFS) was not significantly different for either cediranib alone (hazard ratio [HR] = 1.05; 95% CI, 0.74 to 1.50; two-sided P = .90) or cediranib in combination with lomustine (HR = 0.76; 95% CI, 0.53 to 1.08; two-sided P = .16) versus lomustine based on independent or local review of postcontrast T1-weighted MRI. Conclusion This study did not meet its primary end point of PFS prolongation with cediranib either as monotherapy or in combination with lomustine versus lomustine in patients with recurrent glioblastoma, although cediranib showed evidence of clinical activity on some secondary end points including time to deterioration in neurologic status and corticosteroid-sparing effects.
Url:
Affiliations:
- Allemagne, Australie, Autriche, Belgique, Canada, France, Pays-Bas, Royaume-Uni, États-Unis
- Angleterre, Bade-Wurtemberg, District de Karlsruhe, Grand Londres, Grand Manchester, Hollande-Méridionale, Région de Bruxelles-Capitale, Victoria (État)
- Bruxelles, Heidelberg, Londres, Manchester, Melbourne, Rotterdam
- University College de Londres
Links toward previous steps (curation, corpus...)
- to stream PascalFrancis, to step Corpus: 000827
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- to stream PascalFrancis, to step Checkpoint: 000723
- to stream Main, to step Merge: 004E97
- to stream Pmc, to step Corpus: 001953
- to stream Pmc, to step Curation: 001812
- to stream Pmc, to step Checkpoint: 001956
- to stream PubMed, to step Corpus: 003B20
- to stream PubMed, to step Curation: 003990
- to stream PubMed, to step Checkpoint: 003990
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- to stream Main, to step Curation: 004D46
Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Phase III Randomized Trial Comparing the Efficacy of Cediranib As Monotherapy, and in Combination With Lomustine, Versus Lomustine Alone in Patients With Recurrent Glioblastoma</title>
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<author><name sortKey="Campone, Mario" sort="Campone, Mario" uniqKey="Campone M" first="Mario" last="Campone">Mario Campone</name>
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<affiliation wicri:level="1"><inist:fA14 i1="11"><s1>Barrow Neurological Institute</s1>
<s2>Phoenix, AZ</s2>
<s3>USA</s3>
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<wicri:noRegion>Barrow Neurological Institute</wicri:noRegion>
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<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Anderson Cancer Center</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
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<country>États-Unis</country>
<wicri:noRegion>Anderson Cancer Center</wicri:noRegion>
</affiliation>
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<author><name sortKey="Gattamaneni, Rao" sort="Gattamaneni, Rao" uniqKey="Gattamaneni R" first="Rao" last="Gattamaneni">Rao Gattamaneni</name>
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<s2>Manchester</s2>
<s3>GBR</s3>
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<country>Royaume-Uni</country>
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<region type="région" nuts="1">Grand Manchester</region>
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<author><name sortKey="Cher, Lawrence" sort="Cher, Lawrence" uniqKey="Cher L" first="Lawrence" last="Cher">Lawrence Cher</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Austin Health Cancer Services</s1>
<s3>USA</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Austin Health Cancer Services</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rosenthal, Mark" sort="Rosenthal, Mark" uniqKey="Rosenthal M" first="Mark" last="Rosenthal">Mark Rosenthal</name>
<affiliation wicri:level="3"><inist:fA14 i1="14"><s1>Royal Melbourne Hospital</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
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<author><name sortKey="Payer, Franz" sort="Payer, Franz" uniqKey="Payer F" first="Franz" last="Payer">Franz Payer</name>
<affiliation wicri:level="1"><inist:fA14 i1="15"><s1>Medical University</s1>
<s2>Graz</s2>
<s3>AUT</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Autriche</country>
<wicri:noRegion>Medical University</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jurgensmeier, Juliane M" sort="Jurgensmeier, Juliane M" uniqKey="Jurgensmeier J" first="Juliane M." last="Jürgensmeier">Juliane M. Jürgensmeier</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>AstraZeneca</s1>
<s2>Wilmington, DE</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>AstraZeneca</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jain, Rakesh K" sort="Jain, Rakesh K" uniqKey="Jain R" first="Rakesh K." last="Jain">Rakesh K. Jain</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Massachusetts General Hospital</s1>
<s2>Boston, MA</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Massachusetts General Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gregory Sorensen, A" sort="Gregory Sorensen, A" uniqKey="Gregory Sorensen A" first="A." last="Gregory Sorensen">A. Gregory Sorensen</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Massachusetts General Hospital</s1>
<s2>Boston, MA</s2>
<s3>USA</s3>
<sZ>1 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Massachusetts General Hospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Xu, John" sort="Xu, John" uniqKey="Xu J" first="John" last="Xu">John Xu</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>AstraZeneca</s1>
<s2>Wilmington, DE</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>AstraZeneca</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Qi Liu" sort="Qi Liu" uniqKey="Qi Liu" last="Qi Liu">QI LIU</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>AstraZeneca</s1>
<s2>Wilmington, DE</s2>
<s3>USA</s3>
<sZ>16 aut.</sZ>
<sZ>19 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>AstraZeneca</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Van Den Bent, Martin" sort="Van Den Bent, Martin" uniqKey="Van Den Bent M" first="Martin" last="Van Den Bent">Martin Van Den Bent</name>
<affiliation wicri:level="3"><inist:fA14 i1="17"><s1>Erasmus University Medical Center-Daniel den Hoed Cancer Center</s1>
<s2>Rotterdam</s2>
<s3>NLD</s3>
<sZ>21 aut.</sZ>
</inist:fA14>
<country>Pays-Bas</country>
<placeName><settlement type="city">Rotterdam</settlement>
<region nuts="2" type="province">Hollande-Méridionale</region>
</placeName>
</affiliation>
</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="2013">2013</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>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiangiogenic agent</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Antineoplastic agent</term>
<term>Brain Neoplasms (drug therapy)</term>
<term>Brain Neoplasms (mortality)</term>
<term>Cancerology</term>
<term>Cediranib</term>
<term>Chemotherapy</term>
<term>Comparative study</term>
<term>Drug combination</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Glioblastoma</term>
<term>Glioblastoma (drug therapy)</term>
<term>Glioblastoma (mortality)</term>
<term>Human</term>
<term>Humans</term>
<term>International Agencies</term>
<term>Lomustine</term>
<term>Lomustine (administration & dosage)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Monotherapy</term>
<term>Neoplasm Recurrence, Local (drug therapy)</term>
<term>Neoplasm Recurrence, Local (mortality)</term>
<term>Phase III trial</term>
<term>Prognosis</term>
<term>Quinazolines (administration & dosage)</term>
<term>Randomization</term>
<term>Relapse</term>
<term>Survival Rate</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Agences internationales</term>
<term>Femelle</term>
<term>Glioblastome (mortalité)</term>
<term>Glioblastome (traitement médicamenteux)</term>
<term>Humains</term>
<term>Lomustine (administration et posologie)</term>
<term>Mâle</term>
<term>Pronostic</term>
<term>Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique)</term>
<term>Quinazolines (administration et posologie)</term>
<term>Récidive tumorale locale (mortalité)</term>
<term>Récidive tumorale locale (traitement médicamenteux)</term>
<term>Taux de survie</term>
<term>Tumeurs du cerveau (mortalité)</term>
<term>Tumeurs du cerveau (traitement médicamenteux)</term>
<term>Études de suivi</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Lomustine</term>
<term>Quinazolines</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Lomustine</term>
<term>Quinazolines</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Brain Neoplasms</term>
<term>Glioblastoma</term>
<term>Neoplasm Recurrence, Local</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Brain Neoplasms</term>
<term>Glioblastoma</term>
<term>Neoplasm Recurrence, Local</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Glioblastome</term>
<term>Récidive tumorale locale</term>
<term>Tumeurs du cerveau</term>
</keywords>
<keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Glioblastome</term>
<term>Récidive tumorale locale</term>
<term>Tumeurs du cerveau</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Protocoles de polychimiothérapie antinéoplasique</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>International Agencies</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Prognosis</term>
<term>Survival Rate</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Adulte d'âge moyen</term>
<term>Agences internationales</term>
<term>Essai clinique phase III</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Pronostic</term>
<term>Randomisation</term>
<term>Etude comparative</term>
<term>Cédiranib</term>
<term>Efficacité traitement</term>
<term>Association médicamenteuse</term>
<term>Chimiothérapie</term>
<term>Homme</term>
<term>Récidive</term>
<term>Lomustine</term>
<term>Cancérologie</term>
<term>Glioblastome</term>
<term>Antiangiogénique</term>
<term>Anticancéreux</term>
<term>Monothérapie</term>
<term>Taux de survie</term>
<term>Études de suivi</term>
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<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
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<front><div type="abstract" xml:lang="en">Purpose A randomized, phase III, placebo-controlled, partially blinded clinical trial (REGAL [Recentin in Glioblastoma Alone and With Lomustine]) was conducted to determine the efficacy of cediranib, an oral pan-vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor, either as monotherapy or in combination with lomustine versus lomustine in patients with recurrent glioblastoma. Patients and Methods Patients (N = 325) with recurrent glioblastoma who previously received radiation and temozolomide were randomly assigned 2:2:1 to receive (1) cediranib (30 mg) monotherapy; (2) cediranib (20 mg) plus lomustine (110 mg/m<sup>2</sup>
); (3) lomustine (110 mg/m<sup>2</sup>
) plus a placebo. The primary end point was progression-free survival based on blinded, independent radiographic assessment of postcontrast T1-weighted and noncontrast T2-weighted magnetic resonance imaging (MRI) brain scans. Results The primary end point of progression-free survival (PFS) was not significantly different for either cediranib alone (hazard ratio [HR] = 1.05; 95% CI, 0.74 to 1.50; two-sided P = .90) or cediranib in combination with lomustine (HR = 0.76; 95% CI, 0.53 to 1.08; two-sided P = .16) versus lomustine based on independent or local review of postcontrast T1-weighted MRI. Conclusion This study did not meet its primary end point of PFS prolongation with cediranib either as monotherapy or in combination with lomustine versus lomustine in patients with recurrent glioblastoma, although cediranib showed evidence of clinical activity on some secondary end points including time to deterioration in neurologic status and corticosteroid-sparing effects.</div>
</front>
</TEI>
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<li>Australie</li>
<li>Autriche</li>
<li>Belgique</li>
<li>Canada</li>
<li>France</li>
<li>Pays-Bas</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
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<li>Heidelberg</li>
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<li>Manchester</li>
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<orgName><li>University College de Londres</li>
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<tree><country name="États-Unis"><noRegion><name sortKey="Batchelor, Tracy T" sort="Batchelor, Tracy T" uniqKey="Batchelor T" first="Tracy T." last="Batchelor">Tracy T. Batchelor</name>
</noRegion>
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<name sortKey="Cher, Lawrence" sort="Cher, Lawrence" uniqKey="Cher L" first="Lawrence" last="Cher">Lawrence Cher</name>
<name sortKey="Degroot, John" sort="Degroot, John" uniqKey="Degroot J" first="John" last="Degroot">John Degroot</name>
<name sortKey="Gregory Sorensen, A" sort="Gregory Sorensen, A" uniqKey="Gregory Sorensen A" first="A." last="Gregory Sorensen">A. Gregory Sorensen</name>
<name sortKey="Jain, Rakesh K" sort="Jain, Rakesh K" uniqKey="Jain R" first="Rakesh K." last="Jain">Rakesh K. Jain</name>
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<name sortKey="Mikkelsen, Tom" sort="Mikkelsen, Tom" uniqKey="Mikkelsen T" first="Tom" last="Mikkelsen">Tom Mikkelsen</name>
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<name sortKey="Xu, John" sort="Xu, John" uniqKey="Xu J" first="John" last="Xu">John Xu</name>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Mulholland, Paul" sort="Mulholland, Paul" uniqKey="Mulholland P" first="Paul" last="Mulholland">Paul Mulholland</name>
</region>
<name sortKey="Gattamaneni, Rao" sort="Gattamaneni, Rao" uniqKey="Gattamaneni R" first="Rao" last="Gattamaneni">Rao Gattamaneni</name>
</country>
<country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Neyns, Bart" sort="Neyns, Bart" uniqKey="Neyns B" first="Bart" last="Neyns">Bart Neyns</name>
</region>
</country>
<country name="France"><noRegion><name sortKey="Campone, Mario" sort="Campone, Mario" uniqKey="Campone M" first="Mario" last="Campone">Mario Campone</name>
</noRegion>
</country>
<country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Wick, Antje" sort="Wick, Antje" uniqKey="Wick A" first="Antje" last="Wick">Antje Wick</name>
</region>
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<country name="Canada"><noRegion><name sortKey="Mason, Warren" sort="Mason, Warren" uniqKey="Mason W" first="Warren" last="Mason">Warren Mason</name>
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</region>
</country>
<country name="Autriche"><noRegion><name sortKey="Payer, Franz" sort="Payer, Franz" uniqKey="Payer F" first="Franz" last="Payer">Franz Payer</name>
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</country>
<country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Van Den Bent, Martin" sort="Van Den Bent, Martin" uniqKey="Van Den Bent M" first="Martin" last="Van Den Bent">Martin Van Den Bent</name>
</region>
</country>
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