Inclusion of Six-Year Overall Survival Data in the Eloxatin(R) (oxaliplatin injection) Prescribing Information Granted FDA Prior...(p0.023).Also disease-free survival (risk...),Health

In the MOSAIC trial, the most frequently reported side effect was neutropenia (decrease in the number of white blood cells), with 78.9% of patients affected. Neutropenia was complicated by fever or infection in only 1.8% of cases. 92.1% of patients treated with FOLFOX4 had peripheral sensory neuropathy ("tingling or numbness" in the fingers or toes). Of these events, 12% were severe (grades 3 and 4), and half (48.2%) of the episodes were grade 1. Among patients experiencing grade 3 peripheral sensory neuropathy, partial or total recovery was observed in most cases within 18 months following treatment. Patients receiving FOLFOX4 also reported nausea (73.7%), diarrhea (56.3%) and vomiting (47.2%).

Background on MOSAIC

The MOSAIC Study was conducted in 148 centers in 20 countries and supported by sanofi-aventis. In this phase III randomized-controlled trial, 2,246 patients with Stage II or Stage III colon cancer whose tumor had been completely surgically removed randomly received 5-FU/LV (n=1,123) or FOLFOX4 (n=1,123) every two weeks for 12 cycles. The primary endpoint evaluated how the addition of Eloxatin(R) affected disease-free survival at three years. Secondary endpoints included overall survival and safety, including long-term adverse effects. Based on the data from MOSAIC, Eloxatin(R) in combination with infusional 5-FU/LV was granted U.S. approval in 2004 for the treatment of Stage III colon cancer patients who have their primary tumors surgically removed. At the time of the original analysis, there was no demonstrated benefit in overall survival after a median follow-up of four years.

About Colorectal Cancer

At Stage II, the cancer has grown through the wall of the colon or rectum but has not yet spread to nearby lymph nodes. In Stage III, the cancer has invaded one or more of the
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