UnivTrevesV1, Main, Merge, bibRecord, 001364

Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx) : final results of a multicenter randomized phase II trial in advanced pancreatic cancer

Identifieur interne : 001364 ( Main/Merge ); précédent : 001363; suivant : 001365

Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx) : final results of a multicenter randomized phase II trial in advanced pancreatic cancer

Auteurs : S. Boeck [Allemagne] ; T. Hoehler [Allemagne] ; G. Seipelt [Allemagne] ; R. Mahlberg [Allemagne] ; A. Wein [Allemagne] ; A. Hochhaus [Allemagne] ; H.-P. Boeck [Allemagne] ; B. Schmid [Allemagne] ; E. Kettner [Allemagne] ; M. Stauch [Allemagne] ; F. Lordick [Allemagne] ; Y. Ko [Allemagne] ; M. Geissler [Allemagne] ; K. Schoppmeyer [Allemagne] ; G. Kojouharoff [Allemagne] ; A. Golf [Allemagne] ; S. Neugebauer [Allemagne] ; V. Heinemann [Allemagne]

Source :

Annals of oncology [ 0923-7534 ] ; 2008.

RBID : Pascal:08-0131159

Descripteurs français

Pascal (Inist)
- Capécitabine, Oxaliplatine, Etude comparative, Gemcitabine, Etude multicentrique, Essai clinique, Randomisation, Essai clinique phase II, Homme, Stade avancé, Cancer du pancréas, Chimiothérapie, Anticancéreux.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Antineoplastic agent, Capecitabine, Chemotherapy, Clinical trial, Comparative study, Gemcitabine, Human, Multicenter study, Oxaliplatin, Pancreas cancer, Phase II trial, Randomization.

Abstract

Background: To compare the efficacy and safety of three different chemotherapy doublets in the treatment of advanced pancreatic cancer (PC). Patients and methods: At total of 190 patients were randomly assigned to receive capecitabine 1000 mg/m² twice daily on days 1-14 plus oxaliplatin 130 mg/m² on day 1 (CapOx), capecitabine 825 mg/m² twice daily on days 1-14 plus gemcitabine 1000 mg/m² on days 1 and 8 (CapGem) or gemcitabine 1000 mg/m² on days 1 and 8 plus oxaliplatin 130 mg/m² on day 8 (mGemOx). Treatment cycles were repeated every three weeks. The primary end point was progression-free survival (PFS) rate at 3 months; secondary end points included objective response rate, carbohydrate antigen 19-9 response, clinical benefit response, overall survival and toxicity. Results: The PFS rate after 3 months was 51% in the CapOx arm, 64% in the CapGem arm and 60% in the mGemOx arm. Median PFS was estimated with 4.2 months, 5.7 months and 3.9 months, respectively (P = 0.67). Corresponding median survival times were: 8.1 months (CapOx), 9.0 months (CapGem) and 6.9 months (mGemOx) (P = 0.56). Grade 3/4 hematological toxicities were more frequent in the two Gem-containing arms; grade 3/4 non-hematological toxicity rates did not exceed 15% in any arm. Conclusion: CapOx, CapGem and mGemOx have similar clinical efficacy in advanced PC. Each regimen has a distinct but manageable tolerability profile.

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx) : final results of a multicenter randomized phase II trial in advanced pancreatic cancer</title>
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</author>
<author><name sortKey="Ko, Y" sort="Ko, Y" uniqKey="Ko Y" first="Y." last="Ko">Y. Ko</name>
<affiliation wicri:level="1"><inist:fA14 i1="12"><s1>Innere Medizin I, Johanniter Krankenhaus Bonn</s1>
<s3>DEU</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Johanniter Krankenhaus Bonn</wicri:noRegion>
<wicri:noRegion>Innere Medizin I, Johanniter Krankenhaus Bonn</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Geissler, M" sort="Geissler, M" uniqKey="Geissler M" first="M." last="Geissler">M. Geissler</name>
<affiliation wicri:level="1"><inist:fA14 i1="13"><s1>Medizinische Klinik II, Universitätsklinikum Freiburg</s1>
<s3>DEU</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Universitätsklinikum Freiburg</wicri:noRegion>
<wicri:noRegion>Medizinische Klinik II, Universitätsklinikum Freiburg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Schoppmeyer, K" sort="Schoppmeyer, K" uniqKey="Schoppmeyer K" first="K." last="Schoppmeyer">K. Schoppmeyer</name>
<affiliation wicri:level="1"><inist:fA14 i1="14"><s1>Medizinische Klinik II, Universitätsklinikum Leipzig</s1>
<s3>DEU</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Universitätsklinikum Leipzig</wicri:noRegion>
<wicri:noRegion>Medizinische Klinik II, Universitätsklinikum Leipzig</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Kojouharoff, G" sort="Kojouharoff, G" uniqKey="Kojouharoff G" first="G." last="Kojouharoff">G. Kojouharoff</name>
<affiliation wicri:level="3"><inist:fA14 i1="15"><s1>Onkologische Schwerpunktpraxis</s1>
<s2>Darmstadt</s2>
<s3>DEU</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="1">Hesse (Land)</region>
<region type="district" nuts="2">District de Darmstadt</region>
<settlement type="city">Darmstadt</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Golf, A" sort="Golf, A" uniqKey="Golf A" first="A." last="Golf">A. Golf</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Medizinische Klinik Klinikum Stuttgart-Bürgerhospital</s1>
<s3>DEU</s3>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Medizinische Klinik Klinikum Stuttgart-Bürgerhospital</wicri:noRegion>
<wicri:noRegion>Medizinische Klinik Klinikum Stuttgart-Bürgerhospital</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Neugebauer, S" sort="Neugebauer, S" uniqKey="Neugebauer S" first="S." last="Neugebauer">S. Neugebauer</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>WISP Research Institute</s1>
<s2>Langenfeld</s2>
<s3>DEU</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<wicri:noRegion>Langenfeld</wicri:noRegion>
<wicri:noRegion>WISP Research Institute</wicri:noRegion>
<wicri:noRegion>WISP Research Institute</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Heinemann, V" sort="Heinemann, V" uniqKey="Heinemann V" first="V." last="Heinemann">V. Heinemann</name>
<affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Medizinische Klinik und Poliklinik III, Klinikum Grosshadern, Ludwig-Maximilians-Universität München</s1>
<s3>DEU</s3>
<sZ>1 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><settlement type="city">Munich</settlement>
<region type="land" nuts="1">Bavière</region>
<region type="district" nuts="2">District de Haute-Bavière</region>
</placeName>
<orgName type="university">Université Louis-et-Maximilien de Munich</orgName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Annals of oncology</title>
<title level="j" type="abbreviated">Ann. oncol.</title>
<idno type="ISSN">0923-7534</idno>
<imprint><date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Annals of oncology</title>
<title level="j" type="abbreviated">Ann. oncol.</title>
<idno type="ISSN">0923-7534</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Antineoplastic agent</term>
<term>Capecitabine</term>
<term>Chemotherapy</term>
<term>Clinical trial</term>
<term>Comparative study</term>
<term>Gemcitabine</term>
<term>Human</term>
<term>Multicenter study</term>
<term>Oxaliplatin</term>
<term>Pancreas cancer</term>
<term>Phase II trial</term>
<term>Randomization</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Capécitabine</term>
<term>Oxaliplatine</term>
<term>Etude comparative</term>
<term>Gemcitabine</term>
<term>Etude multicentrique</term>
<term>Essai clinique</term>
<term>Randomisation</term>
<term>Essai clinique phase II</term>
<term>Homme</term>
<term>Stade avancé</term>
<term>Cancer du pancréas</term>
<term>Chimiothérapie</term>
<term>Anticancéreux</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Background: To compare the efficacy and safety of three different chemotherapy doublets in the treatment of advanced pancreatic cancer (PC). Patients and methods: At total of 190 patients were randomly assigned to receive capecitabine 1000 mg/m<sup>2</sup>
 twice daily on days 1-14 plus oxaliplatin 130 mg/m<sup>2</sup>
 on day 1 (CapOx), capecitabine 825 mg/m<sup>2</sup>
 twice daily on days 1-14 plus gemcitabine 1000 mg/m<sup>2</sup>
 on days 1 and 8 (CapGem) or gemcitabine 1000 mg/m<sup>2</sup>
 on days 1 and 8 plus oxaliplatin 130 mg/m<sup>2</sup>
 on day 8 (mGemOx). Treatment cycles were repeated every three weeks. The primary end point was progression-free survival (PFS) rate at 3 months; secondary end points included objective response rate, carbohydrate antigen 19-9 response, clinical benefit response, overall survival and toxicity. Results: The PFS rate after 3 months was 51% in the CapOx arm, 64% in the CapGem arm and 60% in the mGemOx arm. Median PFS was estimated with 4.2 months, 5.7 months and 3.9 months, respectively (P = 0.67). Corresponding median survival times were: 8.1 months (CapOx), 9.0 months (CapGem) and 6.9 months (mGemOx) (P = 0.56). Grade 3/4 hematological toxicities were more frequent in the two Gem-containing arms; grade 3/4 non-hematological toxicity rates did not exceed 15% in any arm. Conclusion: CapOx, CapGem and mGemOx have similar clinical efficacy in advanced PC. Each regimen has a distinct but manageable tolerability profile.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
</country>
<region><li>Bavière</li>
<li>District de Darmstadt</li>
<li>District de Haute-Bavière</li>
<li>Hesse (Land)</li>
</region>
<settlement><li>Darmstadt</li>
<li>Munich</li>
</settlement>
<orgName><li>Université Louis-et-Maximilien de Munich</li>
<li>Université technique de Munich</li>
</orgName>
</list>
<tree><country name="Allemagne"><region name="Bavière"><name sortKey="Boeck, S" sort="Boeck, S" uniqKey="Boeck S" first="S." last="Boeck">S. Boeck</name>
</region>
<name sortKey="Boeck, H P" sort="Boeck, H P" uniqKey="Boeck H" first="H.-P." last="Boeck">H.-P. Boeck</name>
<name sortKey="Geissler, M" sort="Geissler, M" uniqKey="Geissler M" first="M." last="Geissler">M. Geissler</name>
<name sortKey="Golf, A" sort="Golf, A" uniqKey="Golf A" first="A." last="Golf">A. Golf</name>
<name sortKey="Heinemann, V" sort="Heinemann, V" uniqKey="Heinemann V" first="V." last="Heinemann">V. Heinemann</name>
<name sortKey="Hochhaus, A" sort="Hochhaus, A" uniqKey="Hochhaus A" first="A." last="Hochhaus">A. Hochhaus</name>
<name sortKey="Hoehler, T" sort="Hoehler, T" uniqKey="Hoehler T" first="T." last="Hoehler">T. Hoehler</name>
<name sortKey="Kettner, E" sort="Kettner, E" uniqKey="Kettner E" first="E." last="Kettner">E. Kettner</name>
<name sortKey="Ko, Y" sort="Ko, Y" uniqKey="Ko Y" first="Y." last="Ko">Y. Ko</name>
<name sortKey="Kojouharoff, G" sort="Kojouharoff, G" uniqKey="Kojouharoff G" first="G." last="Kojouharoff">G. Kojouharoff</name>
<name sortKey="Lordick, F" sort="Lordick, F" uniqKey="Lordick F" first="F." last="Lordick">F. Lordick</name>
<name sortKey="Mahlberg, R" sort="Mahlberg, R" uniqKey="Mahlberg R" first="R." last="Mahlberg">R. Mahlberg</name>
<name sortKey="Neugebauer, S" sort="Neugebauer, S" uniqKey="Neugebauer S" first="S." last="Neugebauer">S. Neugebauer</name>
<name sortKey="Schmid, B" sort="Schmid, B" uniqKey="Schmid B" first="B." last="Schmid">B. Schmid</name>
<name sortKey="Schoppmeyer, K" sort="Schoppmeyer, K" uniqKey="Schoppmeyer K" first="K." last="Schoppmeyer">K. Schoppmeyer</name>
<name sortKey="Seipelt, G" sort="Seipelt, G" uniqKey="Seipelt G" first="G." last="Seipelt">G. Seipelt</name>
<name sortKey="Stauch, M" sort="Stauch, M" uniqKey="Stauch M" first="M." last="Stauch">M. Stauch</name>
<name sortKey="Wein, A" sort="Wein, A" uniqKey="Wein A" first="A." last="Wein">A. Wein</name>
</country>
</tree>
</affiliations>
</record>

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Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx) : final results of a multicenter randomized phase II trial in advanced pancreatic cancer

Capecitabine plus oxaliplatin (CapOx) versus capecitabine plus gemcitabine (CapGem) versus gemcitabine plus oxaliplatin (mGemOx) : final results of a multicenter randomized phase II trial in advanced pancreatic cancer

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