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 : 001A81 ( Istex/Curation ); précédent : 001A80; suivant : 001A82Capecitabine 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.
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
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S. Boeck<affiliation><mods:affiliation>Medizinische Klinik und Poliklinik III, Klinikum Grosshadern, Ludwig-Maximilians-Universitt Mnchen</mods:affiliation>
<wicri:noCountry code="subField">Mnchen</wicri:noCountry>
</affiliation>
<affiliation><mods:affiliation>I. Medizinische Klinik und Poliklinik, Universitt Mainz</mods:affiliation>
<wicri:noCountry code="subField">Mainz</wicri:noCountry>
</affiliation>
<affiliation><mods:affiliation>Onkologische Schwerpunktpraxis, Bad Soden</mods:affiliation>
<wicri:noCountry code="subField">Soden</wicri:noCountry>
</affiliation>
<affiliation><mods:affiliation>Abteilung Innere Medizin I, Mutterhaus der Borromerinnen, Trier</mods:affiliation>
<wicri:noCountry code="subField">Trier</wicri:noCountry>
</affiliation>
<affiliation><mods:affiliation>III. Medizinische Klinik, Medizinische Fakultt Mannheim, Universitt Heidelberg</mods:affiliation>
<wicri:noCountry code="subField">Heidelberg</wicri:noCountry>
</affiliation>
<affiliation><mods:affiliation>Onkologische Schwerpunktpraxis, Offenbach</mods:affiliation>
<wicri:noCountry code="subField">Offenbach</wicri:noCountry>
</affiliation>
<affiliation><mods:affiliation>Klinik fr Hmatologie/Onkologie, Stdtisches Klinikum Magdeburg</mods:affiliation>
<wicri:noCountry code="subField">Magdeburg</wicri:noCountry>
</affiliation>
<affiliation><mods:affiliation>Onkologische Schwerpunktpraxis, Kronach</mods:affiliation>
<wicri:noCountry code="subField">Kronach</wicri:noCountry>
</affiliation>
<affiliation><mods:affiliation>III. Medizinische Klinik, Klinikum rechts der Isar, Technische Universitt Mnchen</mods:affiliation>
<wicri:noCountry code="subField">Mnchen</wicri:noCountry>
</affiliation>
<affiliation><mods:affiliation>Medizinische Klinik II, Universittsklinikum Freiburg</mods:affiliation>
<wicri:noCountry code="subField">Freiburg</wicri:noCountry>
</affiliation>
<affiliation><mods:affiliation>Medizinische Klinik II, Universittsklinikum Leipzig</mods:affiliation>
<wicri:noCountry code="subField">Leipzig</wicri:noCountry>
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<sourceDesc><biblStruct><analytic><title 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><name sortKey="Stauch, M" sort="Stauch, M" uniqKey="Stauch M" first="M." last="Stauch">M. Stauch</name>
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<author><name sortKey="Lordick, F" sort="Lordick, F" uniqKey="Lordick F" first="F." last="Lordick">F. Lordick</name>
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<wicri:noCountry code="subField">Freiburg</wicri:noCountry>
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<author><name sortKey="Schoppmeyer, K" sort="Schoppmeyer, K" uniqKey="Schoppmeyer K" first="K." last="Schoppmeyer">K. Schoppmeyer</name>
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<author><name sortKey="Heinemann, V" sort="Heinemann, V" uniqKey="Heinemann V" first="V." last="Heinemann">V. Heinemann</name>
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</affiliation>
<affiliation wicri:level="1"><mods:affiliation>E-mail: volker.heinemann@med.uni-muenchen.de</mods:affiliation>
<country wicri:rule="url">Allemagne</country>
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<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>
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<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>
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