Survival of patients with initially unresectable colorectal liver metastases treated with FOLFOX/cetuximab or FOLFIRI/cetuximab in a multidisciplinary concept (CELIM study)

16.0-41.9) months, HR 1.03 (95% CI 0.66-1.61), P= 0.9). The median PFS was 10.8 (95% CI 9.3-12.2) months (arm A: 11.2 (95% CI 7.2-15.3), arm B: 10.5 (95% CI 8.9-12.2) months, HR 1.18 (95% CI 0.79-1.74), P= 0.4). Patients who underwent R0 resection (n= 36) achieved a better median OS (53.9 (95% CI 35.9-71.9) months) than those who did not (21.9 (95% CI 17.1-26.7) months, P< 0.001). The median disease-free survival for R0 resected patients was 9.9 (95% CI 5.8-14.0) months, and the 5-year OS rate was 46.2% (95% CI 29.5% to 62.9%). Conclusions: This study confirms a favourable long-term survival for patients with initially sub-optimal or unresectable colorectal liver metastases who respond to conversion therapy and undergo secondary resection. Both FOLFOX/FOLFIRI plus cetuximab, appear to be appropriate regimens for 'conversion' treatment in patients with K-RAS codon 12/13/61 wild-type tumours. Thus, liver surgery can be considered curative or alternatively as an additional 'line of therapy' in those patients who are not cured. Clinical Trial Number: NCT00153998, www.clinicaltrials.gov.