Skip Navigation


Annals of Oncology Advance Access originally published online on April 25, 2008
Annals of Oncology 2008 19(8):1442-1449; doi:10.1093/annonc/mdn150
This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow Supplementary Material
Right arrow All Versions of this Article:
19/8/1442    most recent
mdn150v1
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in ISI Web of Science
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (8)
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Arnold, D.
Right arrow Articles by Schmoll, H.-J.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Arnold, D.
Right arrow Articles by Schmoll, H.-J.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© 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

gastrointestinal tumors

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.

Key words: 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.


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 NEJMHome page
E. Van Cutsem, C.-H. Kohne, E. Hitre, J. Zaluski, C.-R. Chang Chien, A. Makhson, G. D'Haens, T. Pinter, R. Lim, G. Bodoky, et al.
Cetuximab and Chemotherapy as Initial Treatment for Metastatic Colorectal Cancer
N. Engl. J. Med., April 2, 2009; 360(14): 1408 - 1417.
[Abstract] [Full Text] [PDF]

Home page
 JCOHome page
C. Bokemeyer, I. Bondarenko, A. Makhson, J. T. Hartmann, J. Aparicio, F. de Braud, S. Donea, H. Ludwig, G. Schuch, C. Stroh, et al.
Fluorouracil, Leucovorin, and Oxaliplatin With and Without Cetuximab in the First-Line Treatment of Metastatic Colorectal Cancer
J. Clin. Oncol., February 10, 2009; 27(5): 663 - 671.
[Abstract] [Full Text] [PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.