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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

tive chemotherapy. The primary endpoint was progression-free survival. The primary objective of the trial was to detect a 40% increase in median PFS or equivalently an increase of 3-year PFS from 21% to 32.8% in all patients randomized to perioperative chemotherapy, with 80% power and two-sided significance level of 5%, resulting in HR=0.71.

In this parallel-group trial, 364 patients with up to four liver metastases initially considered resectable were randomly assigned to the standard regimen arm to be treated by either surgery alone or to the experimental arm for treatment with perioperative FOLFOX4 given in six cycles for three months before and six cycles for three months after surgery 182 patients in each arm. Upon further evaluation, 11 patients in each arm were found ineligible for inclusion. In the chemotherapy arm, 159 patients were operated (87.4%) against 170 in the surgery arm (93.4%). Resection of the liver metastases was able to be performed in a similar number of patients in each arm: 152 (83.5%) patients in the surgery arm and 151 patients in the FOLFOX4 arm (83.0%). Of these, 115 patients (63%) also received post-operative chemotherapy.

About Colorectal Cancer

Metastatic colorectal cancer means that the cancer has spread to other nodes and/or organs in the body. The most frequent sites of colorectal cancer metastases are the liver and the lung. More than half of colorectal cancer patients (55%) develop liver metastases, usually within the first two years following surgery removing the primary tumor.

Colorectal cancer is a leading cause of death. Every year, about one million new cases of colorectal cancer are diagnosed worldwide. About 150,000 new cases are detected each year in the United States. According to the American Cancer Society, colorectal cancer is the third leading cause of cancer-related death in the U.S., accounting for about 10% of all cancer deaths. Over a lifetime, about 1 in 18 people develop colorectal
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SOURCE sanofi-aventis
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