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Eloxatin (oxaliplatin injection)-Based Chemotherapy Sets New,Treatment Benchmark in Patients With Metastatic Colorectal Cancer

FOLFOX4 Chemotherapy Results in Improved Long-term [Five-years] Overall Survival for these Seriously Ill Patients

CHICAGO, June 04, 2007 /PRNewswire-FirstCall/ -- FOLFOX4, an Eloxatin(R)-based chemotherapy regimen, provided significant improvements in long-term [five- years] overall survival (OS) and time to disease progression (TTP) - a longer period of stable disease - in patients with metastatic (advanced) colorectal cancer. Importantly, the FOLFOX4 results were significantly better than those achieved with irinotecan-based chemotherapy, known as IFL, and IROX, a combination of irinotecan and Eloxatin(R). These data were presented today at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago in an updated analysis of the N9741 study.

FOLFOX4 (Eloxatin(R) combined with infusional 5-FU/LV) was established in the United States as first line treatment for advanced colorectal cancer after the initial presentation of the N9741 study results in 2003 and subsequent Food and Drug Administration (FDA) approval in January 2004. The updated analysis confirms the earlier results and identifies FOLFOX4 chemotherapy as the strongest predictor of improvement in both overall survival and time to disease progression.

N9741 Five-Year Analysis

This study evaluated several chemotherapy regimens using various combinations of Eloxatin(R), 5-FU/LV and irinotecan in 1,691 previously untreated patients with metastatic colorectal cancer who were randomized to seven arms.

Metastatic colorectal cancer patients given the Eloxatin(R)-based regimen FOLFOX4 were almost twice as likely to survive at least five years as those on irinotecan-based therapy (IFL). Five-year survival and time-to-progression rates were calculated using Kaplan-Meier methods for each treatment arm. Patients treated with FOLFOX4 had a 9.2% overall chance of surviving for five years after treatment, the best
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