Patients who received Eloxatin-based chemotherapy (FOLFOX4) plus bevacizumab (Avastin) showed a statistically significant improvement in overall survival in a large randomized clinical study sponsored by the National Cancer Institute and conducted by the Eastern Cooperative Oncology Group (ECOG).

Preliminary results announced recently are showing a 26 per cent reduction in the risk of death for patients receiving FOLFOX4 plus bevacizumab (Avastin) compared to FOLFOX4 alone. Results of the study will be presented at the ASCO 2005 Gastrointestinal Cancers Symposium in Hollywood, Florida to be held on January 27-29, 2005, according to Sanofi-Aventis release.

According to the NIH, researchers found that the patients in the trial who received bevacizumab in combination with FOLFOX4 had a median overall survival of 12.5 months compared to patients treated with FOLFOX4 alone, who had a median overall survival of 10.7 months. This difference is statistically significant and corresponds to a 17 per cent improvement in median overall survival. There was a 26 per cent reduction in the risk of death (hazard ratio of 0.74) for patients in this study who received bevacizumab plus FOLFOX4 compared to those who received FOLFOX4 alone, the release says.

Sunil Gupta, sanofi-aventis, senior director of Oncology Clinical Development said, "This is the first clinical confirmation that biological agents such as bevacizumab will add to the efficacy of the FOLFOX4 regimen in metastatic colorectal cancer. Additional studies of this combination are ongoing in other colorectal cancer settings."

The study, a phase III randomized study of oxaliplatin, fluorouracil, and leucovorin calcium with or without bevacizumab versus bevacizumab alone in patients with previously treated advanced or metastatic colorectal adenocarcinoma also known as 'E3200', was sponsored by the National Cancer Institute and conducted by a network of researchers led by the Eastern Cooperative Oncology Group. It examined the benefits of adding bevacizumab to the Eloxatin-based therapy (FOLFOX4) in advanced colorectal cancer patients who had previously received chemotherapy treatment.

Eloxatin is the only chemotherapy agent approved around the world in all colon cancer settings, including adjuvant (post-surgical) therapy. Eloxatin- based regimens have become the standard of treatment in colorectal cancer and were the reference therapy in this trial.