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Annals of Oncology Advance Access published online on December 10, 2007
Annals of Oncology, doi:10.1093/annonc/mdm516
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© 2007 European Society for Medical Oncology

First-line single-agent cetuximab in patients with advanced colorectal cancer

A. Pessino1, S. Artale2, S. Sciallero1, A. Guglielmi1, G. Fornarini1, I. C. Andreotti2, S. Mammoliti1, D. Comandini1, F. Caprioni1, E. Bennicelli1, V. Andretta1, S. Siena2 and A. Sobrero1,*

1 Medical Oncology Unit, Ospedale S. Martino, Genoa
2 Oncologia Falck Unit, Ospedale Niguarda Ca’ Granda, Milan, Italy

* Correspondence to: Prof. A. Sobrero, Medical Oncology Unit, Ospedale S. Martino, Largo R. Benzi 10, 16132 Genoa, Italy. Tel: +39-10-5553301; Fax: +39-10-5555139; E-mail: alberto.sobrero{at}hsanmartino.it

Background: The anti-epidermal growth factor receptor (EGFR) antibody cetuximab is active in heavily pretreated patients with metastatic colorectal cancer (mCRC) both in monotherapy and in combination with chemotherapy (CT). This study assesses the antitumor activity of single-agent cetuximab in CT-naive patients.

Patients and methods: Phase II clinical trial was used. Patients were EGFR positive by immunohistochemistry and were not candidate for radical surgery, even in the case of substantial tumor shrinkage. Cetuximab was administered weekly.

Results: Thirty-nine patients were treated and evaluated. The most common adverse event was skin toxicity (89% any grade; 48% grade 1; 31% grade 2; 10% grade 3). One patient had a complete response and three obtained partial responses (10% overall response rate). Thirteen patients had stable disease (34%). Twenty-two patients experienced progressive disease (56%). Overall median time to progression (TTP) was 2 months, and the responders individual TTP was 12, 9, 9, and 6 months.

Conclusions: Even in chemo-naive patients, cetuximab as single agent is active only in a small fraction of mCRC, similarly to what has been reported for heavily pretreated patients. The extent of benefit when response occurs is, however, such that it is mandatory to intensify the search for the predictive markers of response to cetuximab therapy.

biological therapy, cetuximab, colorectal cancer

Received for publication August 30, 2007. Revision received October 5, 2007. Accepted for publication October 8, 2007.


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