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Annals of Oncology Advance Access published online on April 25, 2008
Annals of Oncology, doi:10.1093/annonc/mdn150
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© The Author 2008. 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

Cetuximab in combination with weekly 5-fluorouracil/folinic acid and oxaliplatin (FUFOX) in untreated patients with advanced colorectal cancer: a phase Ib/II study of the AIO GI Group

D. Arnold1, T. Höhler2, C. Dittrich3, F. Lordick4, T. Seufferlein5, J. Riemann6, E. Wöll7, T. Herrmann8, A. Zubel9 and H.-J. Schmoll1,*

1 Department of Oncology and Hematology, Martin-Luther-University Halle-Wittenberg, Halle
2 Johannes-Gutenberg University Hospital, Mainz, Germany
3 ACR-ITR VIEnna and LBI-ACR VIEnna, Kaiser Franz Josef-Spital, Vienna, Austria
4 Klinikum rechts der Isar, Technische Universitaet, Muenchen
5 Universitaets-Klinikum, Ulm
6 Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany
7 University Hospital Innsbruck, Innsbruck, Austria
8 Department of Internal Medicine IV and National Center for Tumor Diseases, University Hospital Heidelberg, Heidelberg
9 Clinical Research and Development, Merck KGaA, Darmstadt, Germany

* Correspondence to: Dr H.-J. Schmoll, Martin Luther Universität Halle Wittenberg, Klinik für Innere Medizin, Abteilung Hämatologie und Onkologie, Ernst Grube Strasse 40, 06120 Halle/Saale, Germany. Tel: +49-345-557-2924; Fax: +49-345-557-2950; E-mail: hans-joachim.schmoll{at}medizin.uni-halle.de

Background: This two-part phase Ib/II study investigated the feasibility of administering cetuximab in combination with oxaliplatin and infusional 5-fluorouracil (5-FU)/folinic acid (FA) in a weekly schedule (AIO FUFOX protocol) as first-line treatment in patients with epidermal growth factor receptor-detectable advanced colorectal cancer.

Patients and methods: Cetuximab was administered weekly: 400 mg/m2 initial dose, then 250 mg/m2 and FUFOX: oxaliplatin 50 mg/m2, FA 500 mg/m2 and 5-FU as a 24-h infusion at either 1500 or 2000 mg/m2 administered for 4 weeks followed by a 1-week rest (one cycle).

Results: Dose-limiting toxicity (grade 3 diarrhea) occurred in 3 of 14 assessable patients receiving 5-FU at standard 2000 mg/m2. This dose was administered to a further 25 patients. Cetuximab combined with FUFOX was generally well tolerated with the most common grade 3/4 adverse events being diarrhea (27%) and paresthesia (16%). The confirmed response rate for patients receiving 5-FU at standard 2000 mg/m2 (N = 41) was 56%, with a median duration of 9.3 months. Median progression-free and overall survival times including all 49 patients were 8.1 (95% confidence interval 6.0–9.7) and 28.2 months, respectively. Cetuximab pharmacokinetics seemed not to be different for combination with FUFOX compared with cetuximab/irinotecan combinations.

Conclusion: This protocol is well tolerated and shows promising efficacy supporting further investigation.

ACRC, cetuximab, EGFR, first-line chemotherapy, FUFOX, oxaliplatin

Received for publication January 17, 2008. Revision received February 21, 2008. Accepted for publication March 6, 2008.


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