An international phase II study of cetuximab in combination with oxaliplatin/5-fluorouracil (5-FU)/folinic acid (FA) (FOLFOX-4) in the first-line treatment of patients with metastatic colorectal cancer (CRC) expressing Epidermal Growth Factor Receptor (EGFR). Preliminary results

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Abstract
3512 Background: Cetuximab (Erbitux) is an IgG1 monoclonal antibody targeting the EGFR, shown to be effective in patients (pts) with EGFR-expressing metastatic CRC refractory to prior irinotecan-based chemotherapy (Cunningham ASCO 2003). Cetuximab has demonstrated high efficacy with an acceptable safety profile in combination with different regimens of irinotecan/FA/5-FU as 1st-line treatment (Rosenberg ASCO 2002; Van Laethem and Folprecht ASCO 2003). This trial was designed to evaluate the efficacy and safety of cetuximab with the FOLFOX-4 regimen as 1st-line treatment. Methods: Pts received cetuximab (400 mg/m2 week 1 and 250 mg/m2 weekly thereafter) plus FOLFOX-4 (every 2 weeks: oxaliplatin 85 mg/m2, day 1; FA 200 mg/m2 IV 2h and 5-FU 400 mg/m2 IV bolus followed by 600 mg/m2 IV for 22h, days 1 and 2) until PD or unacceptable toxicity. Main inclusion criteria included pts with non-resectable metastatic CRC, EGFR expression on tumor, no previous chemotherapy for metastatic CRC, and ECOG PS = 2. Results: Of the 61 pts screened 50 (82%) showed EGFR expression on the tumor. 43 pts have finally been enrolled. Currently, baseline data from 25 enrolled pts are available: M/F 16/9, median age 65 years (range 43–75), colon/rectum 17/8, ECOG PS=0/1 16/9, number of organs affected=1/2/3: 13/9/3. The observed best overall response was based on 20 evaluable pts: 14 (70%) partial response (of these, 7 responses have been confirmed so far), 5 (25%) stable disease, 1 not evaluable who withdrew his consent after 1st infusion. Two pts underwent curative resection of their hepatic metastasis after confirmed response. So far, 8 serious adverse events were observed (4 5-FU related diarrhea, 1 pulmonary embolism, 1 pneumonia, 1 PD with obstructive jaundice, 1 gout) none of them related to cetuximab. Conclusion: These preliminary data suggest that cetuximab may be safe and effective when combined with FOLFOX-4 in first-line treatment of patients with metastatic CRC.

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