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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<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></author><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></author><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></author><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></author><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></author><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></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2016">2016</date><idno type="RBID">pubmed:27255289</idno><idno type="pmid">27255289</idno><idno type="doi">10.1007/s10120-016-0618-0</idno><idno type="wicri:Area/PubMed/Corpus">000126</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000126</idno></publicationStmt><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></affiliation></author><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></author><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></author><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></author><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></author><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></analytic><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></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><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></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2016</Year><Month>6</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>6</Month><Day>4</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">27255289</ArticleId><ArticleId IdType="doi">10.1007/s10120-016-0618-0</ArticleId><ArticleId IdType="pii">10.1007/s10120-016-0618-0</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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