Cetuximab + FOLFOX6 as first line therapy for metastatic colorectal cancer (An International Oncology Network study, I-03–002)

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3557 Background: Cetuximab, an IgG1 monoclonal antibody targeting the EGFR, is currently approved for second line treatment of metastatic colorectal cancer (CRC). This phase II trial was designed to evaluate the safety and efficacy of cetuximab combined with FOLFOX6 as first line therapy in this patient population. Promising results have been reported at ESMO in a similar small pilot study. Methods: Eligibility: Age ≥ 18, locally advanced or metastatic CRC, no prior therapy for advanced disease, EGFR expression positive or undetectable. Regimen: Cetuximab 400 mg/M2 (2 hour infusion) day 1; 250 mg/M2 day 8 (and 250 mg/M2 for all subsequent doses); and modified FOLFOX 6 (2 hour infusion); and 5FU bolus 400 mg/M2 day 1 followed by 5FU-CI 2400 mg/M2 over 46 hours (days 1 and 2). Cycles were repeated every 14 days. Results: 82 patients were enrolled in the study. The median number of treatment cycles administered was 8. (range 1–28) At the time of this report, 23 patients are still on study. Reasons for discontinuation of therapy included: Toxicity (14 patients), disease progression (20), investigator /patient decision (11), planned therapy completed (3). Five patients (6%) died on study. Causes of death included: PD (2 patients), acute MI (1), respiratory failure secondary to pneumonia (1), sudden death of unknown cause (1). The most frequently observed toxicity was neutropenia. Grade 3/4 toxicities are listed in the table below. At this early analysis time point, 32 of 60 patients evaluable for response have documented CR/PR (3 CR, 29 PR, overall response rate of 53%). A pre-meeting update is planned for presentation purposes. Conclusion: These findings suggest that the combination of cetuximab with FOLFOX6 is safe and active in first line treatment of patients with metastatic CRC. Updated efficacy and safety data will be presented. [Table: see text] No significant financial relationships to disclose.

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