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 : 001091 ( Main/Exploration ); précédent : 001090; suivant : 001092Capecitabine 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 ; T. Hoehler ; G. Seipelt ; R. Mahlberg ; A. Wein [Allemagne] ; A. Hochhaus ; H.-P. Boeck ; B. Schmid [Allemagne] ; E. Kettner ; M. Stauch ; F. Lordick ; Y. Ko [Allemagne] ; M. Geissler ; K. Schoppmeyer ; G. Kojouharoff [Allemagne] ; A. Golf ; S. Neugebauer [Allemagne] ; V. Heinemann [Allemagne]Source :
- Annals of Oncology [ 0923-7534 ] ; 2007-10-24.
Descripteurs français
- Pascal (Inist)
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- topic : Homme.
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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 114 plus oxaliplatin 130 mg/m2 on day 1 (CapOx), capecitabine 825 mg/m2 twice daily on days 114 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 (P0.67). Corresponding median survival times were: 8.1 months (CapOx), 9.0 months (CapGem) and 6.9 months (mGemOx) (P0.56). 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.
Url:
DOI: 10.1093/annonc/mdm467
Affiliations:
- Allemagne
- Bade-Wurtemberg, Bavière, District de Cologne, District de Darmstadt, District de Moyenne-Franconie, District de Stuttgart, Hesse (Land), Rhénanie-du-Nord-Westphalie
- Bonn, Darmstadt, Erlangen, Stuttgart
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Le document en format XML
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Boeck</name><affiliation><wicri:noCountry code="subField">Mnchen</wicri:noCountry></affiliation></author><author><name sortKey="Hoehler, T" sort="Hoehler, T" uniqKey="Hoehler T" first="T." last="Hoehler">T. Hoehler</name><affiliation><wicri:noCountry code="subField">Mainz</wicri:noCountry></affiliation></author><author><name sortKey="Seipelt, G" sort="Seipelt, G" uniqKey="Seipelt G" first="G." last="Seipelt">G. Seipelt</name><affiliation><wicri:noCountry code="subField">Soden</wicri:noCountry></affiliation></author><author><name sortKey="Mahlberg, R" sort="Mahlberg, R" uniqKey="Mahlberg R" first="R." last="Mahlberg">R. Mahlberg</name><affiliation><wicri:noCountry code="subField">Trier</wicri:noCountry></affiliation></author><author><name sortKey="Wein, A" sort="Wein, A" uniqKey="Wein A" first="A." last="Wein">A. 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Schmid</name><affiliation wicri:level="3"><country>Allemagne</country><placeName><settlement type="city">Stuttgart</settlement><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Stuttgart</region></placeName><wicri:orgArea>Zentrum fr Innere Medizin III</wicri:orgArea></affiliation></author><author><name sortKey="Kettner, E" sort="Kettner, E" uniqKey="Kettner E" first="E." last="Kettner">E. Kettner</name><affiliation><wicri:noCountry code="subField">Magdeburg</wicri:noCountry></affiliation></author><author><name sortKey="Stauch, M" sort="Stauch, M" uniqKey="Stauch M" first="M." last="Stauch">M. Stauch</name><affiliation><wicri:noCountry code="subField">Kronach</wicri:noCountry></affiliation></author><author><name sortKey="Lordick, F" sort="Lordick, F" uniqKey="Lordick F" first="F." last="Lordick">F. Lordick</name><affiliation><wicri:noCountry code="subField">Mnchen</wicri:noCountry></affiliation></author><author><name sortKey="Ko, Y" sort="Ko, Y" uniqKey="Ko Y" first="Y." last="Ko">Y. Ko</name><affiliation wicri:level="3"><country>Allemagne</country><placeName><settlement type="city">Bonn</settlement><region type="land" nuts="1">Rhénanie-du-Nord-Westphalie</region><region type="district" nuts="2">District de Cologne</region></placeName><wicri:orgArea>Innere Medizin I</wicri:orgArea></affiliation></author><author><name sortKey="Geissler, M" sort="Geissler, M" uniqKey="Geissler M" first="M." last="Geissler">M. Geissler</name><affiliation><wicri:noCountry code="subField">Freiburg</wicri:noCountry></affiliation></author><author><name sortKey="Schoppmeyer, K" sort="Schoppmeyer, K" uniqKey="Schoppmeyer K" first="K." last="Schoppmeyer">K. Schoppmeyer</name><affiliation><wicri:noCountry code="subField">Leipzig</wicri:noCountry></affiliation></author><author><name sortKey="Kojouharoff, G" sort="Kojouharoff, G" uniqKey="Kojouharoff G" first="G." last="Kojouharoff">G. Kojouharoff</name><affiliation wicri:level="3"><country>Allemagne</country><placeName><settlement type="city">Darmstadt</settlement><region type="land" nuts="1">Hesse (Land)</region><region type="district" nuts="2">District de Darmstadt</region></placeName><wicri:orgArea>Onkologische Schwerpunktpraxis</wicri:orgArea></affiliation></author><author><name sortKey="Golf, A" sort="Golf, A" uniqKey="Golf A" first="A." last="Golf">A. Golf</name><affiliation><wicri:noCountry code="subField">StuttgartBrgerhospital</wicri:noCountry></affiliation></author><author><name sortKey="Neugebauer, S" sort="Neugebauer, S" uniqKey="Neugebauer S" first="S." last="Neugebauer">S. Neugebauer</name><affiliation wicri:level="1"><country xml:lang="fr">Allemagne</country><wicri:regionArea>WiSP Research Institute, Langenfeld</wicri:regionArea><wicri:noRegion>Langenfeld</wicri:noRegion><wicri:noRegion>Langenfeld</wicri:noRegion></affiliation></author><author><name sortKey="Heinemann, V" sort="Heinemann, V" uniqKey="Heinemann V" first="V." last="Heinemann">V. Heinemann</name><affiliation></affiliation><affiliation wicri:level="1"><country wicri:rule="url">Allemagne</country></affiliation></author></analytic><monogr></monogr><series><title level="j">Annals of Oncology</title><idno type="ISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="2007-10-24">2007-10-24</date><biblScope unit="volume">19</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="340">340</biblScope><biblScope unit="page" to="347">347</biblScope></imprint><idno type="ISSN">0923-7534</idno></series><idno type="istex">63A4984D5059554695E6B4A219AD96D53FD55483</idno><idno type="DOI">10.1093/annonc/mdm467</idno></biblStruct></sourceDesc><seriesStmt><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>Anticancéreux</term><term>Cancer du pancréas</term><term>Capécitabine</term><term>Chimiothérapie</term><term>Essai clinique</term><term>Essai clinique phase II</term><term>Etude comparative</term><term>Etude multicentrique</term><term>Gemcitabine</term><term>Homme</term><term>Oxaliplatine</term><term>Randomisation</term><term>Stade avancé</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="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 114 plus oxaliplatin 130 mg/m2 on day 1 (CapOx), capecitabine 825 mg/m2 twice daily on days 114 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 (P0.67). Corresponding median survival times were: 8.1 months (CapOx), 9.0 months (CapGem) and 6.9 months (mGemOx) (P0.56). 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>Bade-Wurtemberg</li><li>Bavière</li><li>District de Cologne</li><li>District de Darmstadt</li><li>District de Moyenne-Franconie</li><li>District de Stuttgart</li><li>Hesse (Land)</li><li>Rhénanie-du-Nord-Westphalie</li></region><settlement><li>Bonn</li><li>Darmstadt</li><li>Erlangen</li><li>Stuttgart</li></settlement></list><tree><noCountry><name sortKey="Boeck, H P" sort="Boeck, H P" uniqKey="Boeck H" first="H.-P." last="Boeck">H.-P. Boeck</name><name sortKey="Boeck, S" sort="Boeck, S" uniqKey="Boeck S" first="S." last="Boeck">S. 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="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="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="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></noCountry><country name="Allemagne"><region name="Bavière"><name sortKey="Wein, A" sort="Wein, A" uniqKey="Wein A" first="A." last="Wein">A. Wein</name></region><name sortKey="Heinemann, V" sort="Heinemann, V" uniqKey="Heinemann V" first="V." last="Heinemann">V. Heinemann</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="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></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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