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Originally published as JCO Early Release 10.1200/JCO.2005.05.546 on June 6 2005

Journal of Clinical Oncology, Vol 23, No 22 (August 1), 2005: pp. 4856-4865
© 2005 American Society of Clinical Oncology.
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Phase III Study of Weekly High-Dose Infusional Fluorouracil Plus Folinic Acid With or Without Irinotecan in Patients With Metastatic Colorectal Cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986

C.-H. Köhne, E. van Cutsem, J. Wils, C. Bokemeyer, M. El-Serafi, M.P. Lutz, M. Lorenz, P. Reichardt, H. Rückle-Lanz, N. Frickhofen, R. Fuchs, H.-G. Mergenthaler, T. Langenbuch, U. Vanhoefer, P. Rougier, R. Voigtmann, L. Müller, B. Genicot, Ö. Anak, B. Nordlinger

From the Department of Internal Medicine, University of Dresden, Dresden; Universitätsklinik Tübingen, Tübingen; Medizinische Klinik, Saarbrücken; Charite Virchow Klinikum, Berlin; Medizinische Poliklinik der Universität, Würzburg; Dr.-Horst-Schmidt-Kliniken GmbH, Wiesbaden; St Antonius-Hospital, Eschweiler; Katharinhospital, Stuttgart; Kreiskrankenhaus, Aurich; University of Essen, Essen; Marienenhospital Ruhr University, Herne; Onkologische Schwerpunkpraxis, Leer, Germany; University Hospital, Gasthuisberg, Leuven; European Organisation for Research and Treatment of Cancer Data Center, Brussels, Belgium; Laurentius Ziekenhuis, Roermond, the Netherlands; National Cancer Institute, Cairo, Egypt; and Hopital Ambroise Paré, Boulogne, France
Deceased.

Address reprint requests to Claus-Henning Köhne, MD, Klinikum Oldenburg, Klinik für Oncology/Hematology, Dr.-Edenstr. 10, 26133 Oldenburg, Germany; e-mail: onkologie{at}klinikum-oldenburg.de

PURPOSE: To demonstrate that adding irinotecan to a standard weekly schedule of high-dose, infusional fluorouracil (FU) and leucovorin (folinic acid [FA]) can prolong progression-free survival (PFS).

PATIENTS AND METHODS: Four hundred thirty patients with measurable or assessable metastatic colorectal cancer were randomly assigned to receive either FA 500 mg/m2 as a 2-hour infusion and FU 2.6 g/m2 by intravenous 24-hour infusion, both administered weekly for 6 weeks, followed by a 2-week rest (Arbeitsgemeinschaft für Internistische Onkologie [AIO] arm, n = 216), or a similar schedule but with FU 2.3 or 2.0 g/m2 preceded by irinotecan 80 mg/m2 administered over 30 minutes (experimental group, n = 214).

RESULTS: The median PFS time in the experimental group was 8.5 months (95% CI, 7.6 to 9.9 months) compared with 6.4 months (95% CI, 5.3 to 7.2 months) in the AIO arm (P < .0001). The median overall survival time was increased from 16.9 to 20.1 months (P = .2779). The objective response rate was 62.2% (95% CI, 55.0% to 69.5%) in the experimental group and 34.4% (95% CI, 27.5% to 41.3%) in the AIO arm (P < .0001).

CONCLUSION: The addition of irinotecan to the standard AIO FU/FA regimen was associated with a highly significant improvement in PFS and response rate and was well tolerated. The results of this study confirm that irinotecan in combination with high-dose infusional FU/FA is a reference first-line treatment.

Supported by an educational grant from Aventis Pharma, Antony, France.

Presented at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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