Related Pages Colon and Rectal Cancer Home Page NCI's gateway for information about colon and rectal cancer. Highlights from ASCO 2003 A collection of links to material summarizing some of the important clinical trial results announced at the 2003 annual meeting of the American Society of Clinical Oncology (ASCO).

Key Words: chemotherapy, colorectal cancer, FOLFOX, oxaliplatin, MOSAIC trial. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary.)

Summary
The chemotherapy combination known as FOLFOX – oxaliplatin, 5-fluorouracil (5-FU), and leucovorin – significantly improved disease-free survival compared to 5-FU and leucovorin when used as adjuvant therapy (after surgery) in patients with stage II and stage III colorectal cancer.

Source
American Society of Clinical Oncology (ASCO) annual meeting, Chicago, June 1, 2003. Final results subsequently published in the June 3, 2004, issue of the New England Journal of Medicine (see the journal abstract).

Background: The FOLFOX combination has proved successful with advanced and metastatic colorectal cancer in previous clinical trials, but these are the first findings to demonstrate its benefit in less advanced disease. The results emerged from the International Randomized MOSAIC Trial, led by Aimery De Gramont, M.D., Hopital Saint Antoine, Paris, France.

The Study
In this randomized phase III trial, 2,246 patients with stage II and stage III colorectal cancer were divided into two groups. One group received infusional 5-FU and leucovorin after surgery and the other group received the FOLFOX combination. Treatments were given twice a month for six months. All of these agents are commercially available.

Results
At three years after surgery, 77.8 percent of the FOLFOX group had survived without recurrence of the cancer compared to 72.9 percent of those who had received 5-FU and leucovorin. This amounts to a 23 percent reduction in the risk of recurrence for the FOLFOX group – a “highly significant result,” according to De Gramont.

The two groups had a similar rate of death from any cause, at 0.5 percent, indicating that FOLFOX was safe in this group of patients. Substantial sensory neuropathy (pain, numbness, tingling, swelling, and muscle weakness in various parts of the body) occurred in 12 percent of patients receiving FOLFOX, but within one year this condition disappeared in all but 1 percent of the FOLFOX group.

Limitations
Overall survival data are not yet available for this trial. The data can only be applied to patients with stage II and III colorectal cancer in whom the tumor has been completely removed by surgery.

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