Cetuximab in combination with oxaliplatin/5-fluorouracil (5-FU)/folinic acid (FA) (FOLFOX-4) in the first-line treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer: An international phase II study

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Abstract
3535 Background: Cetuximab (Erbitux), an IgG1 monoclonal antibody that specifically targets EGFR the receptor, is effective in combination with irinotecan or irinotecan/5-FU/FA in patients with EGFR-expressing mCRC in the first and second-/subsequent-line settings. The study was designed to evaluate the safety and efficacy of cetuximab in combination with FOLFOX-4 as first-line treatment. Methods: Pts with non-resectable EGFR-expressing mCRC, with no prior chemotherapy, were treated with 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 progressive disease (PD) or unacceptable toxicity. Preliminary Results: Of the 62 pts, median ECOG performance status 0 (0–2), screened, 52 pts (84%) had EGFR-expressing metastatic disease, 43 pts, median age 65 yrs (range 43–78) were finally enrolled. All of the patients are assessable for safety and efficacy. Main adverse events grade 3/4 (pts ≥10%, multiple cycle) observed per pt: acne-like rash 30.2%, diarrhea 25.6%, neurotoxicity 25.6%, neutropenia 20.9%, stomatitis/mucositis 16.3%. The efficacy data on 42 pts yielded an overall confirmed response rate of 72%, comprising 4 (9%) complete responses (CR) and 27 (63%) partial responses (PR). There were also 10 (23%) pts with stable disease to yield a disease control rate of 95%. 8 pts are still on treatment. PFS is 10.2 months. To date, 10 pts have undergone surgery of their metastases: 8 for liver, 1 for lung, 1 for suprarenal gland metastases (9 R0 resections). Conclusions: The combination of cetuximab and FOLFOX-4 has an acceptable safety profile and demonstrates advantages in response rate in the first-line treatment of patients with EGFR-expressing mCRC.

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