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Phase II trial of cetuximab in combination with fluorouracil, leucovorin, and oxaliplatin in the first-line treatment of metastatic colorectal cancer.

Tabernero J, Van Cutsem E, Diaz-Rubio E et al. Journal of Clinical Oncology, 2007, 25, 5225-5232

In this article, Tabernero and colleagues investigated the feasibility of administering cetuximab in combination with 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX-4) as first-line treatment in 43 patients with epidermal growth factor receptor (EGFR)-detectable metastatic colorectal cancer (mCRC).

In this Phase II trial, median progression-free survival was 12.3 months and, after a follow-up of 30.5 months, median overall survival was 30.0 months. In fact, these data are among the best obtained for mCRC, and this study suggests that cetuximab is efficacious and safe when combined with oxaliplatin-based chemotherapy.

Of importance, approximately 50% of patients with colorectal cancer develop liver metastases at some point during the course of their disease, and systemic chemotherapy is the treatment of choice, but is traditionally used with palliative intent. Moreover, only surgical resection of liver metastases can increase survival. Biologically targeting the EGFR in combination with FOLFOX-4 has the potential ability to render formerly unresectable metastatic patients resectable.

The results achieved in this trial are the highest estimated up to now for unselected patients [10 patients (23%) were rendered resectable with curative intent using this systemic therapy and nine patients (21%) had no evidence of residual disease after surgery].

Cetuximab, oxaliplatin and fluoropyrimidine combination was well tolerated and the dermatological toxicity (acneiform rash) was the typical adverse effect seen using anti-EGFR biological agents. The intensity of the dermatological reaction seems to be correlated to activity of this drug. Besides, the most common grade 3/4 adverse events were diarrhoea, neutropenia and paraesthesia.

In conclusion, this biological agent directed against EGFR did not increase the toxicity of chemotherapy. Cetuximab in combination with FOLFOX-4 appears to be a very promising first-line regimen for treatment of mCRC. Nevertheless, these results are restricted to a small number of patients, therefore it is necessary to wait for the data from larger randomised Phase II/III trials to confirm the role of cetuximab, oxaliplatin and fluoropyrmidine in the first-line treatment of mCRC.

Commentary by Roberto Labianca and Barbara Merelli (1)

(1) Medical Oncology Unit, Ospedali Riuniti, Bergamo, Italy

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Author:Labianca, Roberto; Merelli, Barbara
Publication:Advances in Gastrointestinal Cancer
Article Type:Report
Geographic Code:4EUIT
Date:Jun 1, 2008
Words:355
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