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Annals of Oncology Advance Access originally published online on March 17, 2008
Annals of Oncology 2008 19(7):1288-1292; doi:10.1093/annonc/mdn058
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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

Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK

M. Borner*, D. Koeberle, R. Von Moos, P. Saletti, D. Rauch, V. Hess, A. Trojan, D. Helbling, B. Pestalozzi, C. Caspar, T. Ruhstaller, A. Roth, A. Kappeler, D. Dietrich, D. Lanz, W. Mingrone and for the Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland

Institute of Medical Oncology, Inselspital, Bern, Switzerland

* Correspondence to: Prof M. Borner, Institute of Medical Oncology, Inselspital, 3010 Bern, Switzerland. Tel: 0041 632 84 42; Fax: 0041 632 41 19; E-mail: markus.borner{at}insel.ch

Background: To determine the activity and tolerability of adding cetuximab to the oxaliplatin and capecitabine (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC).

Patients and methods: In a multicenter two-arm phase II trial, patients were randomized to receive oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice daily on days 1–14 every 3 weeks alone or in combination with standard dose cetuximab. Treatment was limited to a maximum of six cycles.

Results: Seventy-four patients with good performance status entered the trial. Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively. Stable disease has been observed in 62% and 35% of the patients, with 76% disease control in both arms. Cetuximab led to skin rash in 65% of the patients. The median overall survival was 16.5 months for arm A and 20.5 months for arm B. The median time to progression was 5.8 months for arm A and 7.2 months for arm B.

Conclusion: Differences in response rates between the treatment arms indicate that cetuximab may improve outcome with XELOX. The correct place of the cetuximab, oxaliplatin and fluoropyrimidine combinations in first-line treatment of MCC has to be assessed in phase III trials.

Key words: capecitabine, cetuximab, metastatic colorectal cancer, oxaliplatin, randomized phase II

Received for publication November 17, 2007. Revision received February 10, 2008. Accepted for publication February 11, 2008.


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