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The Eloxatin-Based Regimen (FOLFOX4) Significantly Improved,Progression Free Survival When Given Before and After Surgery in,Patients With Resectable Liver Metastases From Colorectal Cancer

re were 25.2% surgical complications in the peri-operative chemotherapy arm and 15.9% in the surgery alone arm (P=0.04); the operative mortality remains very low (<1%), whatever the treatment arm: two deaths after surgery in the standard arm and one in the experimental arm.

"The EPOC study is an ambitious trial and the largest clinical trial of its kind conducted in this patient group. Its success is due largely to the international cooperation and the multidisciplinary team effort of healthcare professionals," said principal investigator Professor Bernard Nordlinger, past chairman of the EORTC GI group, chair of the Department of Surgery and Oncology, Hospital Ambroise Pare, Assistance Publique-Hôpitaux de Paris, Boulogne, France. "These results suggest that the treatment paradigm for colorectal cancer liver metastases may change to include peri-operative oxaliplatin-based chemotherapy."

About the EPOC Study

The EPOC (Eloxatin(R) for Peri-Operative Use) Study is a randomized multicenter phase III intergroup study sponsored and conducted by the EORTC (European Organization for Research and Treatment of Cancer), in collaboration with AGITG (Australasian Gastro-Intestinal Trials Group), EORTC GITCG (EORTC Gastrointestinal Tract Cancer Group), ALM-CAO (Arbeitsgruppe Lebermetastasen und -tumoren in der Chirurgischen Arbeitsgemeinschaft Onkologie), CRUK (Cancer Research UK) and FFCD (Fondation Francophone de Cancerologie Digestive). It was supported by sanofi-aventis.

This trial evaluated the benefit of combining peri-operative chemotherapy and surgery for patients with resectable liver metastases from colorectal cancer. Progression-Free Survival (PFS) was the primary endpoint. The objective of the trial was to demonstrate a 40% increase in median PFS, with 80% power and two-sided significance level of 5%, resulting in HR=0.71. Safety data, a secondary end-point, were previously reported at ASCO in 2005.

A total of 364 pat
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