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Cetuximab in combination with 5-fluorouracil, leucovorin and irinotecan as a neoadjuvant chemotherapy in patients with initially unresectable colorectal liver metastases.

Min BS, Kim NK, Ahn JB, Roh JK, Kim KS, Choi JS, Cha SH, Kim H

Department of Surgery, Colorectal Cancer Clinic, Severance Hospital, Yonsei University Medical Center, Yonsei University College of Medicine, Seoul, Korea.

BACKGROUND: The efficacy and safety of a combination of cetuximab, irinotecan, and 5-fluorouracil/leucovorin (FOLFIRI) in downsizing unresectable colorectal liver metastases was investigated. PATIENTS AND METHODS: Patients with unresectable colorectal liver metastases with or without resectable extrahepatic metastasis were enrolled. 23 patients initially received 400 mg/m2 of cetuximab, followed by a weekly infusion of 250 mg/m2 and a biweekly dose of irinotecan (180 mg/m2), with 5-fluorouracil both by bolus (400 mg/m2) and by a 46-h infusion (total of 2,400 mg/m2) with leucovorin (400 mg/m2). RESULTS: The overall response rate was 39.1% (n = 9; 95% confidence interval (CI): 17.6-60.7%). The most common grade 3-4 toxicities were skin reactions (30.4%) and diarrhea (26.1%). The rate of conversion to resectable liver metastases was 30.4% (n = 7; 95% CI: 10.1-50.8%). The factors found to be significantly associated with R0 resection were lower serum carcinoembryonic antigen levels after chemotherapy (p = 0.039), being chemonaive (p = 0.002), and showing a higher incidence of grade 3-4 skin toxicity (p = 0.011). CONCLUSIONS: Cetuximab with FOLFIRI may be an effective and safe treatment option for downsizing unresectable colorectal liver metastases.

Published 7 December 2007 in Onkologie, 30(12): 637-43.
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