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Annals of Oncology Advance Access originally published online on December 6, 2007
Annals of Oncology 2008 19(5):920-926; doi:10.1093/annonc/mdm544
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© The Author 2007. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

gastrointestinal tumors

Irinotecan combined with infusional 5-fluorouracil/folinic acid or capecitabine plus celecoxib or placebo in the first-line treatment of patients with metastatic colorectal cancer. EORTC study 40015

C.-H. Köhne1,*, J. De Greve2, J. T. Hartmann3, I. Lang4, P. Vergauwe5, K. Becker6, D. Braumann7, E. Joosens8, L. Müller9, J. Janssens10, C. Bokemeyer11, P. Reimer12, H. Link13, E. Späth-Schwalbe14, H.-J. Wilke15, H. Bleiberg16, J. Van Den Brande17, M. Debois18, U. Bethe18 and E. Van Cutsem19

1 Department of Oncology and Hematology, Klinikum Oldenburg, Oldenburg, Germany
2 Department of Oncology, Universitair Ziekenhuis Brussel, Vrije Universiteit, Brussels, Belgium
3 University Medical Center II, Eberhard-Karls-Universität, Tübingen, Germany
4 Department of Medical Oncology, National Institute of Oncology, Budapest, Hungary
5 Department of Internal Medicine, AZ Groeninghe, Campus Sint-Niklaas, Kortrijk, Belgium
6 Onkologischer Schwerpunkt Lerchenfeld, Hamburg
7 II. Medizinische Abteilung, Allgemeines Krankenhaus Altona, Hamburg, Germany
8 Department of Hemato-Oncology, Ziekenhuis Netwerk Middelheim, Campus Middelheim, Antwerpen, Belgium
9 Onkologische Schwerpunktpraxis Leer, Leer, Germany
10 Department of Gastroenterology, Sint-Elisabeth Ziekenhuis, Turnhout, Belgium
11 Department of Oncology and Hematology, Universitätsklinikum Hamburg-Eppendorf, Hamburg
12 Medizinische Klinik III, Würzburg
13 Medizinische Klinik I, Westpfalz-Kinikum, Kaiserslautern
14 Medical Department, Hematology, Oncology and Gastroenterology, Vivantes Klinkum Spandau, Berlin
15 Department of Oncology, Kliniken Essen-Mitte, Essen, Germany
16 Department of Gastroenterology, Chemotherapy Unit, Institut Jules Bordet, Brussels
17 Department of Medical Oncology, Universitair Ziekenhuis Antwerpen, Edegem
18 European Organisation for Research and Treatment of Cancer (EORTC), EORTC Data Center, Brussels
19 Digestive Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium

* Correspondence to: Prof. C.-H. Köhne, Department of Oncology and Hematology, Klinikum Oldenburg GmbH, Dr Eden Strasse 10, 26133 Oldenburg, Germany. Tel: +49-441-403-2611; Fax: +49-441-403-2654; E-mail: onkologie{at}klinikum-oldenburg.de

Background: The study aimed to demonstrate the noninferiority of capecitabine to 5-fluorouracil (5-FU)/folinic acid (FA), in relation to progression-free survival (PFS) after first-line treatment of metastatic colorectal cancer and the benefit of adding celecoxib (C) to irinotecan/fluoropyrimidine regimens compared with placebo (P).

Patients and methods: Patients were randomly assigned to receive FOLFIRI: irinotecan (180 mg/m2 i.v. on days 1, 15 and 22); FA (200 mg/m2 i.v. on days 1, 2, 15, 16, 29 and 30); 5-FU (400 mg/m2 i.v. bolus, then 22-h, 600 mg/m2 infusion) or CAPIRI: irinotecan (250 mg/m2 i.v. infusion on days 1 and 22); capecitabine p.o. (1000 mg/m2 b.i.d. on days 1–15 and 22–36). Patients were additionally randomly assigned to receive either placebo or celecoxib (800 mg: 2 x 200 mg b.i.d.).

Results: The trial was closed following eight deaths unrelated to disease progression in the 85 enrolled (629 planned) patients. Response rates were 22% for CAPIRI + C, 48% for CAPIRI + P, 32% for FOLFIRI + C and 46% for FOLFIRI + P. Median PFS and overall survival (OS) times were shorter for CAPIRI versus FOLFIRI (PFS 5.9 versus 9.6 months and OS 14.8 versus 19.9 months) and celecoxib versus placebo (PFS 6.9 versus 7.8 months and OS 18.3 versus 19.9 months).

Conclusion: Due to the small sample size following early termination, no definitive conclusions can be drawn in relation to the noninferiority of CAPIRI compared with FOLFIRI.

Key words: capecitabine, celecoxib, colorectal, first line, 5-FU, irinotecan

Received for publication July 29, 2007. Revision received October 28, 2007. Accepted for publication October 29, 2007.


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