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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

Presentation at ASCO Plenary Session Reports EORTC 40983 (EPOC) Intergroup Study Results

CHICAGO, June 04, 2007 /PRNewswire-FirstCall/ -- Results of the randomized phase III EORTC 40983 Intergroup study, or EPOC study, demonstrate for the first time that peri-operative (pre and post surgery) FOLFOX4 (Eloxatin(R) (oxaliplatin injection) in combination with a standard chemotherapy regimen for colon cancer, 5-fluorouracil/leucovorin (5-FU/LV)) given to patients with resectable liver metastases from colorectal cancer significantly improved Progression-Free Survival (PFS) compared to surgery alone. (PFS is the time from the start of therapy until disease progression or death). The EPOC study results were presented today at the Plenary Session of the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL.

At a median follow-up of three years, FOLFOX4 treatment given before and after surgery significantly improved PFS by 9.2% and reduced the risk of relapse by 27% (HR=0.73, p=0.025) among patients for whom resection was successful. When evaluating results among all randomized patients, including the 61 patients who were not able to undergo liver metastases resection or were ineligible, FOLFOX4 did not significantly improve PFS compared to surgery alone (7.2% absolute difference, p=0.058). However, when taking into account all eligible patients (171 in each arm), even those not resected, FOLFOX4 treatment significantly improved PFS by 8.1% and reduced the risk of relapse by 23% (H=0.77, CI:0.60-1.00 ; p=0.041).Results showed that FOLFOX4 given before resection did not prevent patients' ability to undergo surgery.

The most common adverse events were with preoperative chemotherapy: diarrhea (Grade3: 8.2%), sensory neuropathy (Grade3: 2.3%), neutropenia (Grade3/4:18.1%); and with post-operative chemotherapy: sensory neuropathy (Grade3: 9.6%), neutropenia (Grade3/4: 34.8%). The
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