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Annals of Oncology Advance Access published online on October 24, 2007
Annals of Oncology, doi:10.1093/annonc/mdm467
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© 2007 European Society for Medical Oncology

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

S. Boeck1, T. Hoehler2, G. Seipelt3, R. Mahlberg4, A. Wein5, A. Hochhaus6, H.-P. Boeck7, B. Schmid8, E. Kettner9, M. Stauch10, F. Lordick11, Y. Ko12, M. Geissler13, K. Schoppmeyer14, G. Kojouharoff15, A. Golf16, S. Neugebauer17 and V. Heinemann1,*

1 Medizinische Klinik und Poliklinik III, Klinikum Grosshadern, Ludwig-Maximilians-Universität München
2 I. Medizinische Klinik und Poliklinik, Universität Mainz
3 Onkologische Schwerpunktpraxis, Bad Soden
4 Abteilung Innere Medizin I, Mutterhaus der Borromäerinnen, Trier
5 Medizinische Klinik I, Universitätsklinikum Erlangen
6 III. Medizinische Klinik, Medizinische Fakultät Mannheim, Universität Heidelberg
7 Onkologische Schwerpunktpraxis, Offenbach
8 Zentrum für Innere Medizin III, Marienhospital Stuttgart
9 Klinik für Hämatologie/Onkologie, Städtisches Klinikum Magdeburg
10 Onkologische Schwerpunktpraxis, Kronach
11 III. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität München
12 Innere Medizin I, Johanniter Krankenhaus Bonn
13 Medizinische Klinik II, Universitätsklinikum Freiburg
14 Medizinische Klinik II, Universitätsklinikum Leipzig
15 Onkologische Schwerpunktpraxis, Darmstadt
16 Medizinische Klinik I, Klinikum Stuttgart—Bürgerhospital
17 WiSP Research Institute, Langenfeld, Germany

* Correspondence to: Prof. V. Heinemann, Medizinische Klinik und Poliklinik III, Klinikum Grosshadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, D-81377 München, Germany. Tel: +49-89-7095-2208; Fax: +49-89-7095-5256; E-mail: volker.heinemann{at}med.uni-muenchen.de

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.

capecitabine, chemotherapy, gemcitabine, pancreatic cancer, oxaliplatin

Received for publication July 23, 2007. Revision received August 24, 2007. Accepted for publication August 27, 2007.


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