Phase I study of orally administered S-1 in combination with epirubicin and oxaliplatin in patients with advanced solid tumors and chemotherapy-naïve advanced or metastatic esophagogastric cancer.
Identifieur interne : 000126 ( PubMed/Corpus ); précédent : 000125; suivant : 000127Phase I study of orally administered S-1 in combination with epirubicin and oxaliplatin in patients with advanced solid tumors and chemotherapy-naïve advanced or metastatic esophagogastric cancer.
Auteurs : Markus Moehler ; Rolf Mahlberg ; Volker Heinemann ; Radka Obermannová ; Eugen Kubala ; Bohuslav Melichar ; Arndt Weinmann ; Paul Scigalla ; Marietta Tesa Ová ; Petr Janda ; Fabienne Hédouin-Biville ; Wasat MansoorSource :
- Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association [ 1436-3305 ] ; 2016.
Abstract
This phase I study investigated the safety and the maximum tolerated dose (MTD) of the oral fluoropyrimidine S-1 when combined with epirubicin and oxaliplatin (EOS).
DOI: 10.1007/s10120-016-0618-0
PubMed: 27255289
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pubmed:27255289Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Phase I study of orally administered S-1 in combination with epirubicin and oxaliplatin in patients with advanced solid tumors and chemotherapy-naïve advanced or metastatic esophagogastric cancer.</title>
<author><name sortKey="Moehler, Markus" sort="Moehler, Markus" uniqKey="Moehler M" first="Markus" last="Moehler">Markus Moehler</name>
<affiliation><nlm:affiliation>I. Medizinische Klinik und Poliklinik, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany. markus.moehler@unimedizin-mainz.de.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Mahlberg, Rolf" sort="Mahlberg, Rolf" uniqKey="Mahlberg R" first="Rolf" last="Mahlberg">Rolf Mahlberg</name>
<affiliation><nlm:affiliation>Mutterhaus Der Borromaerinnen, Trier, Germany.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Heinemann, Volker" sort="Heinemann, Volker" uniqKey="Heinemann V" first="Volker" last="Heinemann">Volker Heinemann</name>
<affiliation><nlm:affiliation>Department of Medical Oncology, Klinikum Grosshadern, University of Munich, Munich, Germany.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Obermannova, Radka" sort="Obermannova, Radka" uniqKey="Obermannova R" first="Radka" last="Obermannová">Radka Obermannová</name>
<affiliation><nlm:affiliation>Clinic of Comprehensive Cancer Care, MOU, Brno, Czech Republic.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Kubala, Eugen" sort="Kubala, Eugen" uniqKey="Kubala E" first="Eugen" last="Kubala">Eugen Kubala</name>
<affiliation><nlm:affiliation>Faculty Hospital Hradec Králové, Hradec Králové, Czech Republic.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Melichar, Bohuslav" sort="Melichar, Bohuslav" uniqKey="Melichar B" first="Bohuslav" last="Melichar">Bohuslav Melichar</name>
<affiliation><nlm:affiliation>Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.</nlm:affiliation>
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<author><name sortKey="Weinmann, Arndt" sort="Weinmann, Arndt" uniqKey="Weinmann A" first="Arndt" last="Weinmann">Arndt Weinmann</name>
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<author><name sortKey="Scigalla, Paul" sort="Scigalla, Paul" uniqKey="Scigalla P" first="Paul" last="Scigalla">Paul Scigalla</name>
<affiliation><nlm:affiliation>Pharmaceutical Research Consulting, Berlin, Germany.</nlm:affiliation>
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<author><name sortKey="Tesa Ova, Marietta" sort="Tesa Ova, Marietta" uniqKey="Tesa Ova M" first="Marietta" last="Tesa Ová">Marietta Tesa Ová</name>
<affiliation><nlm:affiliation>Prague Clinical Services, Prague, Czech Republic.</nlm:affiliation>
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<author><name sortKey="Janda, Petr" sort="Janda, Petr" uniqKey="Janda P" first="Petr" last="Janda">Petr Janda</name>
<affiliation><nlm:affiliation>Prague Clinical Services, Prague, Czech Republic.</nlm:affiliation>
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<author><name sortKey="Hedouin Biville, Fabienne" sort="Hedouin Biville, Fabienne" uniqKey="Hedouin Biville F" first="Fabienne" last="Hédouin-Biville">Fabienne Hédouin-Biville</name>
<affiliation><nlm:affiliation>Nordic Group, Paris, France.</nlm:affiliation>
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<author><name sortKey="Mansoor, Wasat" sort="Mansoor, Wasat" uniqKey="Mansoor W" first="Wasat" last="Mansoor">Wasat Mansoor</name>
<affiliation><nlm:affiliation>The Christie Hospital NHS Foundation Trust, Manchester, UK.</nlm:affiliation>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Phase I study of orally administered S-1 in combination with epirubicin and oxaliplatin in patients with advanced solid tumors and chemotherapy-naïve advanced or metastatic esophagogastric cancer.</title>
<author><name sortKey="Moehler, Markus" sort="Moehler, Markus" uniqKey="Moehler M" first="Markus" last="Moehler">Markus Moehler</name>
<affiliation><nlm:affiliation>I. Medizinische Klinik und Poliklinik, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany. markus.moehler@unimedizin-mainz.de.</nlm:affiliation>
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<author><name sortKey="Mahlberg, Rolf" sort="Mahlberg, Rolf" uniqKey="Mahlberg R" first="Rolf" last="Mahlberg">Rolf Mahlberg</name>
<affiliation><nlm:affiliation>Mutterhaus Der Borromaerinnen, Trier, Germany.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Heinemann, Volker" sort="Heinemann, Volker" uniqKey="Heinemann V" first="Volker" last="Heinemann">Volker Heinemann</name>
<affiliation><nlm:affiliation>Department of Medical Oncology, Klinikum Grosshadern, University of Munich, Munich, Germany.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Obermannova, Radka" sort="Obermannova, Radka" uniqKey="Obermannova R" first="Radka" last="Obermannová">Radka Obermannová</name>
<affiliation><nlm:affiliation>Clinic of Comprehensive Cancer Care, MOU, Brno, Czech Republic.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Kubala, Eugen" sort="Kubala, Eugen" uniqKey="Kubala E" first="Eugen" last="Kubala">Eugen Kubala</name>
<affiliation><nlm:affiliation>Faculty Hospital Hradec Králové, Hradec Králové, Czech Republic.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Melichar, Bohuslav" sort="Melichar, Bohuslav" uniqKey="Melichar B" first="Bohuslav" last="Melichar">Bohuslav Melichar</name>
<affiliation><nlm:affiliation>Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Weinmann, Arndt" sort="Weinmann, Arndt" uniqKey="Weinmann A" first="Arndt" last="Weinmann">Arndt Weinmann</name>
<affiliation><nlm:affiliation>I. Medizinische Klinik und Poliklinik, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Scigalla, Paul" sort="Scigalla, Paul" uniqKey="Scigalla P" first="Paul" last="Scigalla">Paul Scigalla</name>
<affiliation><nlm:affiliation>Pharmaceutical Research Consulting, Berlin, Germany.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Tesa Ova, Marietta" sort="Tesa Ova, Marietta" uniqKey="Tesa Ova M" first="Marietta" last="Tesa Ová">Marietta Tesa Ová</name>
<affiliation><nlm:affiliation>Prague Clinical Services, Prague, Czech Republic.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Janda, Petr" sort="Janda, Petr" uniqKey="Janda P" first="Petr" last="Janda">Petr Janda</name>
<affiliation><nlm:affiliation>Prague Clinical Services, Prague, Czech Republic.</nlm:affiliation>
</affiliation>
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<author><name sortKey="Hedouin Biville, Fabienne" sort="Hedouin Biville, Fabienne" uniqKey="Hedouin Biville F" first="Fabienne" last="Hédouin-Biville">Fabienne Hédouin-Biville</name>
<affiliation><nlm:affiliation>Nordic Group, Paris, France.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Mansoor, Wasat" sort="Mansoor, Wasat" uniqKey="Mansoor W" first="Wasat" last="Mansoor">Wasat Mansoor</name>
<affiliation><nlm:affiliation>The Christie Hospital NHS Foundation Trust, Manchester, UK.</nlm:affiliation>
</affiliation>
</author>
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<series><title level="j">Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association</title>
<idno type="eISSN">1436-3305</idno>
<imprint><date when="2016" type="published">2016</date>
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<front><div type="abstract" xml:lang="en">This phase I study investigated the safety and the maximum tolerated dose (MTD) of the oral fluoropyrimidine S-1 when combined with epirubicin and oxaliplatin (EOS).</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">27255289</PMID>
<DateCreated><Year>2016</Year>
<Month>06</Month>
<Day>03</Day>
</DateCreated>
<DateRevised><Year>2016</Year>
<Month>06</Month>
<Day>03</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1436-3305</ISSN>
<JournalIssue CitedMedium="Internet"><PubDate><Year>2016</Year>
<Month>Jun</Month>
<Day>02</Day>
</PubDate>
</JournalIssue>
<Title>Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association</Title>
<ISOAbbreviation>Gastric Cancer</ISOAbbreviation>
</Journal>
<ArticleTitle>Phase I study of orally administered S-1 in combination with epirubicin and oxaliplatin in patients with advanced solid tumors and chemotherapy-naïve advanced or metastatic esophagogastric cancer.</ArticleTitle>
<Pagination><MedlinePgn></MedlinePgn>
</Pagination>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">This phase I study investigated the safety and the maximum tolerated dose (MTD) of the oral fluoropyrimidine S-1 when combined with epirubicin and oxaliplatin (EOS).</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Patients aged ≥18 years with advanced or metastatic solid tumors were enrolled in a 3 + 3 design with S-1 dose escalation (two planned cohorts) performed according to the occurrence of dose-limiting toxicity (DLT). On day 1 of each 21-day cycle, patients received epirubicin 50 mg/m(2) followed by oxaliplatin 130 mg/m(2) (maximum 8 cycles) and then S-1 [20 mg/m(2) (cohort 1) or 25 mg/m(2) (cohort 2), twice daily]: first dose, evening of day 1; subsequent administration on days 2-14, twice daily; last dose, morning of day 15 (unlimited number of S-1 cycles). After protocol amendment, enrollment in a third cohort was restricted to patients with chemotherapy-naïve advanced or metastatic esophagogastric cancer.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">DLT was reported for two of the five patients in cohort 2, defining 20 mg/m(2) twice daily as the MTD of S-1 combined with epirubicin and oxaliplatin in heavily pretreated patients. Thirteen patients with chemotherapy-naïve advanced or metastatic esophagogastric cancer were subsequently enrolled and treated at an S-1 dose level of 25 mg/m(2) twice daily; no DLTs were reported; median overall survival was 13.1 months. Of the 11 evaluable patients, three (27 %) had partial responses and seven (64 %) had stable disease. The safety profile was in line with expectations.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The promising activity of EOS (S-1 dose level, 25 mg/m(2) twice daily) and acceptable safety profile support further clinical development of this combination for the first-line treatment of patients with advanced or metastatic esophagogastric cancer.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Moehler</LastName>
<ForeName>Markus</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>I. Medizinische Klinik und Poliklinik, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany. markus.moehler@unimedizin-mainz.de.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mahlberg</LastName>
<ForeName>Rolf</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Mutterhaus Der Borromaerinnen, Trier, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Heinemann</LastName>
<ForeName>Volker</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>Department of Medical Oncology, Klinikum Grosshadern, University of Munich, Munich, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Obermannová</LastName>
<ForeName>Radka</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Clinic of Comprehensive Cancer Care, MOU, Brno, Czech Republic.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Kubala</LastName>
<ForeName>Eugen</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Faculty Hospital Hradec Králové, Hradec Králové, Czech Republic.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Melichar</LastName>
<ForeName>Bohuslav</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Weinmann</LastName>
<ForeName>Arndt</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>I. Medizinische Klinik und Poliklinik, University Medical Center, Johannes Gutenberg-University Mainz, Langenbeckstraße 1, 55131, Mainz, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Scigalla</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Pharmaceutical Research Consulting, Berlin, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Tesařová</LastName>
<ForeName>Marietta</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Prague Clinical Services, Prague, Czech Republic.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Janda</LastName>
<ForeName>Petr</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Prague Clinical Services, Prague, Czech Republic.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hédouin-Biville</LastName>
<ForeName>Fabienne</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Nordic Group, Paris, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Mansoor</LastName>
<ForeName>Wasat</ForeName>
<Initials>W</Initials>
<AffiliationInfo><Affiliation>The Christie Hospital NHS Foundation Trust, Manchester, UK.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<PublicationTypeList><PublicationType UI="">Journal Article</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>06</Month>
<Day>02</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>Japan</Country>
<MedlineTA>Gastric Cancer</MedlineTA>
<NlmUniqueID>100886238</NlmUniqueID>
<ISSNLinking>1436-3291</ISSNLinking>
</MedlineJournalInfo>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Advanced gastric cancer</Keyword>
<Keyword MajorTopicYN="N">Epirubicin</Keyword>
<Keyword MajorTopicYN="N">First-line chemotherapy</Keyword>
<Keyword MajorTopicYN="N">Oxaliplatin</Keyword>
<Keyword MajorTopicYN="N">S-1</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year>
<Month>03</Month>
<Day>14</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2016</Year>
<Month>05</Month>
<Day>21</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2016</Year>
<Month>6</Month>
<Day>4</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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