Sanofi-aventis announced that the US Food and Drug Administration (FDA) approved the supplemental new drug application (sNDA) to include six-year overall survival analysis from the Mosaic trial in the Eloxatin (oxaliplatin injection) prescribing information (PI).

The new PI also reports five-year disease free survival (DFS) data in stage III colon cancer patients treated following surgery to remove the primary tumour.

The randomized phase III study (Mosaic) compared the safety and efficacy of Folfox4 (Eloxatin + 5-FU/LV) compared to 5-FU/LV alone in stage II and III colon cancer patients. No significant benefit was seen in stage II patients. The primary endpoint was DFS.

The Mosaic trial results showed that after a median follow-up of six years, Stage III colon cancer patients treated with Folfox4 had a 20 per cent reduction in the risk of dying compared to those treated with standard chemotherapy alone (hazard ratio of 0.80, confidence interval [0.65, 0.97], p=0.023). Also, Stage III patients treated with the Eloxatin-based regimen at 5 years were 22 per cent less likely to relapse or risk of disease recurrence (HR=0.78, [CI: 0.65, 0.93], p =0.005) after 77 month follow-up.

"The Mosaic six-year follow-up data demonstrate that as an adjuvant treatment for stage III colon cancer, the Eloxatin-based regimen significantly lowered the risk of death and recurrence," said principal investigator Aimery de Gramont, MD, Oncology, Hospital Saint Antoine, Paris, France.

In the MOSAIC trial, neutropenia (decrease in the number of white blood cells), was the most frequently reported side effect, affecting 78.9% of patients. Neutropenia was complicated by fever or infection in only 1.8% of cases. Peripheral sensory neuropathy ("tingling or numbness" in the fingers or toes) occurred in 92.1% of patients treated with FOLFOX4 Half (48.2%) of the episodes were grade 1, and 12% were severe (grades 3 and 4). Partial or total recovery was observed within 18 months following treatment in most patients experiencing grade 3 peripheral sensory neuropathy. Patients treated with Folfox4 also reported nausea (73.7%), diarrhoea (56.3%) and vomiting (47.2%).

"This announcement is welcome news for patients who have a significantly higher chance of surviving stage III colon cancer when treated with the Eloxatin-based regimen following surgery," noted Dr. de Gramont. "Inclusion of these survival results in the new US Eloxatin PI marks an important milestone in the treatment of colon cancer."

Eloxatin in combination with infusional 5-FU/LV was first granted U.S. approval in 2004 for the treatment of Stage III colon cancer patients who have their primary tumours surgically removed based on the disease free survival data from Mosaic after a median follow-up of three years. At the time of the original analysis, there was no demonstrated benefit in overall survival after a median follow-up of four years.