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Annals of Oncology Advance Access originally published online on February 14, 2008
Annals of Oncology 2008 19(6):1141-1145; doi:10.1093/annonc/mdn020
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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

gastrointestinal tumors

Biweekly cetuximab and irinotecan as third-line therapy in patients with advanced colorectal cancer after failure to irinotecan, oxaliplatin and 5-fluorouracil

P. Pfeiffer1,*, D. Nielsen3, J. Bjerregaard1, C. Qvortrup1,2, M. Yilmaz4 and B. Jensen3

1 Department of Oncology, Odense University Hospital
2 Department of Oncology, Institute of Clinical Research, University of Southern Denmark, Odense
3 Department of Oncology, Herlev Hospital, University of Copenhagen, Herlev
4 Department of Oncology, Aalborg University Hospital, Aalborg, Denmark

* Correspondence to: Prof. P. Pfeiffer, Department of Oncology, Odense University Hospital, Sdr. Boulevard 29, DK-5000 Odense C, Denmark Tel: +45 6541 1590; Fax: +45 6541 2957; E-mail: Per.Pfeiffer{at}ouh.regionsyddanmark.dk

Background: Standard weekly cetuximab and irinotecan (CetIri) is an effective regimen in heavily pretreated patients with advanced colorectal cancer (ACRC). Inspired by a pharmacokinetic study demonstrating no differences between weekly and biweekly cetuximab, we present the results of 74 consecutive patients treated with biweekly CetIri.

Methods: Biweekly CetIri schedule: cetuximab 500 mg/m2, first course was given as a 120-min infusion followed 1 h later by irinotecan 180 mg/m2 as a 30-min infusion. Subsequent courses of cetuximab were given in 60 min, immediately followed by irinotecan—resulting in an overall treatment time of 90 min.

Results: All patients had ACRC resistant to 5-fluorouracil and irinotecan and 95% to oxaliplatin. Median age was 63 years, median performance status was 0. Median duration of therapy was 4.3 months. Response rate was 25%. Median progression-free survival and overall survival were 5.4 months and 8.9 months, respectively, comparable to own historical controls receiving weekly CetIri. Grade 3–4 toxicity was rare (skin 7%, nail 3%, diarrhoea 10%, fatigue 3%, neutropenia 9%). One patient experienced severe allergic reaction.

Conclusion: Salvage therapy with simplified biweekly CetIri is a convenient, effective and well-tolerated regimen in heavily pretreated patients with ACRC. A confirmatory phase II study is ongoing.

Key words: advanced colorectal cancer, biweekly, cetuximab, irinotecan, third-line therapy

Received for publication November 1, 2007. Revision received January 3, 2008. Accepted for publication January 7, 2008.


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