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Perioperative Eloxatin(R)-Based Regimen Significantly Reduced the Risk of Relapse Versus Surgery Alone in Eligible Colorectal Cancer Patients with Initially Resectable Liver Metastases
Date:3/20/2008

- EPOC Results Published in March 22 Issue of The Lancet -

BRIDGEWATER, N.J., March 20 /PRNewswire-FirstCall/ -- Sanofi-aventis today announced that efficacy results of the randomized phase III EORTC 40983 Intergroup study published in the March 22 issue of The Lancet showed that in eligible patients Eloxatin(R) (oxaliplatin injection) in combination with 5-fluorouracil/leucovorin (5-FU/LV), a chemotherapy regimen called FOLFOX4, significantly improved three-year PFS (Progression-Free Survival) compared to surgery alone when given perioperatively (before and after surgery) to colorectal cancer patients with initially resectable liver metastases. PFS is the time from randomization until disease progression/recurrence or death. The EORTC 40983 Intergroup study is also referred to as the EPOC (Eloxatin(R) for Peri-Operative Use) trial.

Among the 342 eligible patients treated in the EPOC study, perioperative FOLFOX4 chemotherapy and surgery significantly improved PFS by 8.1% (from 28.1% to 36.2%) versus surgery alone (Hazard Ratio (HR) of 0.77; Confidence Interval (CI): 0.60-1.00; p=0.041). Among patients who were also able to undergo resection of the liver metastases, post-entry (n=303), perioperative FOLFOX4 significantly improved PFS by 9.2% (from 33.2% to 42.4%) compared with surgery alone (HR=0.73 (CI: 0.55-0.97, p=0.025)).

"Seventy-five percent of patients relapse after liver metastases have been surgically removed. We found that the investigational use of perioperative FOLFOX4 reduces the risk of relapse by one fourth over surgery alone," 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-Hopitaux de Paris, Boulogne, France. "EPOC is the first randomized phase III clinical trial to demonstrate three-year PFS of perioperative FOLFOX4 in eligible metastatic colorectal patients with initially resect
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