Journal
BRITISH JOURNAL OF CANCER
Volume 103, Issue 10, Pages 1542-1547Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/sj.bjc.6605940
Keywords
cetuximab; colorectal liver metastases; neoadjuvant chemotherapy; chronotherapy; liver resectability
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Funding
- Associazione Italiana Ricerca sul Cancro [1485]
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BACKGROUND: We assessed the effectiveness of cetuximab plus chronomodulated irinotecan, 5-fluorouracil (5-FU), leucovorin (FA) and oxaliplatin (L-OHP) (chrono-IFLO) administered as neoadjuvant chemotherapy to increase the resectability of colorectal liver metastases. METHODS: This was a phase II prospective trial with rate of liver metastases resection as primary end point. Forty-three patients with unresectable metastases were enroled: 9 with metastases 45 cm; 29 with multinodular (44) disease; 1 with hilar location; 4 with extrahepatic lung disease. Treatment consisted of cetuximab at day 1 plus chronomodulated irinotecan 5-FU, FA and L-OHP for 2-6 days every 2 weeks. After the first 17 patients, doses were reduced for irinotecan to 110 mg m(-2), 5-FU to 550 mg m(-2) per day and L-OHP to 15 mg m(-2) per day. RESULTS: Macroscopically complete resections were performed in 26 out of 43 patients (60%) after a median of 6 (range 3-15) cycles. Partial response was noticed in 34 patients (79%). Median overall survival was 37 months (95% CI: 21-53 months), with a 2-year survival of 68% in the entire population, 80.6% in resected patients and 47.1% in unresected patients (P=0.01). Grade 3/4 diarrhoea occurred in 93% and 36% of patients before and after dose reduction. CONCLUSION: Cetuximab plus chrono-IFLO achieved 60% complete resectability of colorectal liver metastases. British Journal of Cancer (2010) 103, 1542-1547. doi:10.1038/sj.bjc.6605940 www.bjcancer.com Published online 19 October 2010 (C) 2010 Cancer Research UK
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