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Annals of Oncology Advance Access originally published online on February 13, 2008
Annals of Oncology 2008 19(4):734-738; doi:10.1093/annonc/mdm607
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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

A randomised phase III study on capecitabine, oxaliplatin and bevacizumab with or without cetuximab in first-line advanced colorectal cancer, the CAIRO2 study of the Dutch Colorectal Cancer Group (DCCG). An interim analysis of toxicity

J. Tol1, M. Koopman1, C. J. Rodenburg2, A. Cats3, G. J. Creemers5, J. G. Schrama6, F. L. G. Erdkamp7, A. H. Vos8, L. Mol9, N. F. Antonini4 and C. J. A. Punt1,*

1 Department of Medical Oncology, University Medical Centre St Radboud, Nijmegen
2 Department of Internal Medicine, Meander Medical Centre, Amersfoort
3 Department of Gastroenterology, The Netherlands Cancer Institute, Amsterdam
4 Department of Biometrics
5 Catharina Hospital, Eindhoven
6 Department of Internal Medicine, Spaarne Hospital, Hoofddorp
7 Department of Internal Medicine, Maasland Hospital Sittard, Sittard
8 Department of Internal Medicine, Bernhoven Hospital, Oss
9 Comprehensive Cancer Centre East (IKO), Nijmegen, The Netherlands

* Correspondence to: Prof. C. J. A. Punt, Department of Medical Oncology, University Medical Centre St Radboud, PO Box 9101, 6500 HB Nijmegen, The Netherlands. Tel: +31-24-3610353; Fax: +31-24-3540788; E-mail: c.punt{at}onco.umcn.nl

Background: Targeting the vascular endothelial growth factor or the epidermal growth factor receptor (EGFR) has shown efficacy in advanced colorectal cancer (ACC), but no data are available on the combination of these strategies with chemotherapy in the first-line treatment. The CAIRO2 study evaluates the effect of adding cetuximab, a chimeric mAb against EGFR, to capecitabine, oxaliplatin and bevacizumab in the first-line treatment of ACC.

Patients and methods: In all, 755 patients were randomly assigned between treatment with capecitabine, oxaliplatin and bevacizumab with or without cetuximab. The primary end point is progression-free survival. We here present the toxicity results in the first 400 patients that entered the study.

Results: The incidence of overall grade 3–4 toxicity was significantly higher in arm B compared with arm A (81% versus 72%, P = 0.03). This difference is fully attributed to cetuximab-related skin toxicity. The addition of cetuximab did not result in an increase of gastrointestinal toxicity or treatment-related mortality.

Conclusions: The addition of cetuximab to capecitabine, oxaliplatin and bevacizumab in the first-line treatment of ACC appears to be safe and feasible. No excessive or unexpected toxicity in the cetuximab-containing treatment arm was observed.

Key words: advanced colorectal cancer, bevacizumab, cetuximab, chemotherapy, interim analysis, safety

Received for publication December 18, 2007. Accepted for publication December 19, 2007.


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