Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Colon and Rectal Cancer Home Page 2 NCI's gateway for information about colon and rectal cancer. Highlights from ASCO 2003 3 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

Colorectal cancer, FOLFOX, oxaliplatin, MOSAIC trial. (Definitions of many terms related to cancer can be found in the Cancer.gov Dictionary ⁴.)

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.

Glossary Terms

A drug used to treat symptoms of cancer of the colon, breast, stomach, and pancreas. It is also used in a cream to treat certain skin conditions. 5-FU stops cells from making DNA and it may kill cancer cells. It is a type of antimetabolite. Also called 5-fluorouracil and fluorouracil.

The length of time after treatment for a specific disease during which a patient survives with no sign of the disease. Disease-free survival may be used in a clinical study or trial to help measure how well a new treatment works. Also called DFS and disease-free survival time.

A method of putting fluids, including drugs, into the bloodstream. Also called intravenous infusion.

The active ingredient in a drug used to lessen the toxic effects of substances that block the action of folic acid, especially the anticancer drug methotrexate. Leucovorin is used to treat some types of anemia and is also used together with fluorouracil to treat colorectal cancer. It is also being studied in the treatment of other types of cancer and other conditions. Leucovorin is a form of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Also called folinic acid.

Having to do with metastasis, which is the spread of cancer from the primary site (place where it started) to other places in the body.

A drug used together with other drugs to treat colorectal cancer that is advanced or has come back. It is also being studied in the treatment of other types of cancer. Oxaliplatin attaches to DNA in cells and may kill cancer cells. It is a type of platinum compound. Also called Eloxatin.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.

A study in which the participants are assigned by chance to separate groups that compare different treatments; neither the researchers nor the participants can choose which group. Using chance to assign people to groups means that the groups will be similar and that the treatments they receive can be compared objectively. At the time of the trial, it is not known which treatment is best. It is the patient's choice to be in a randomized trial.

Cancer has spread outside the colon and/or rectum to nearby tissue, but it has not gone into the lymph nodes. Also called Dukes B colorectal cancer.

Tumor cells have spread to organs and lymph nodes near the colon/rectum. Also called Dukes C colorectal cancer.