Results: Patients' characteristics were well balanced except for metastatic sites (liver + other in 88% versus 76% of patients receiving oxaliplatin/5-FU or 5-FU, respectively). Safety results are in line with the safety profiles of the drugs, without any unexpected toxicities (Cassidy, ASCO 2003). Median number of cycles (10) was the same in both arms, with a higher dose of 5-FU in the control arm. Median cumulative dose of oxaliplatin was 845 mg/m 2 . Relative oxaliplatin dose intensity was 87%. Direct efficacy evaluation of the first- line treatment showed improvement in response rate (RR) (54% versus 30%, p<0.0001) and progression- free survival (PFS) (7.9 versus 5.9 months, p<0.0001) in the oxaliplatin arm in accordance with previously reported trials. This did not translate into overall survival advantage (15.9 versus 15.2 months), with a median in the oxaliplatin arm below the 19-20 months obtained in more recent studies. Conclusion: These results confirm the improvement in RR and PFS observed with combination therapy in first-line ACRC. Overall survival results could be explained by the low number of patients receiving second- line irinotecan therapy in the oxaliplatin arm (41%) and thus being exposed to the three active agents: 5-FU, oxaliplatin, and irinotecan. ABSTRACT Male/female, %