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Brand name(s): Xeloda®

• Approved for Dukes' stage C colon cancer

Full prescribing information ³ is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

Dukes’ stage C colon cancer is when the cancer has spread outside the colon to one or more lymph nodes; also called stage III colon cancer.

Approval is based on non-inferiority in disease-free survival (DFS) to bolus 5-fluorouracil plus leucovorin (5-FU/LV). In 2004, the FDA approved oxaliplatin for injection (Eloxatin™) in combination with infusional 5-FU/LV for adjuvant stage III colon cancer. Although neither capecitabine nor the combination of oxaliplatin plus 5-FU/LV prolonged overall survival in the adjuvant setting, the combination chemotherapy regimen was associated with an improvement in DFS compared to 5-FU/LV in stage III colon cancer. Physicians should consider these results when prescribing single-agent capecitabine in the adjuvant treatment of Dukes' C colon cancer.

Safety and efficacy for capecitabine in the adjuvant indication were demonstrated in one multicenter, randomized, open-label, international clinical trial. There were 1987 patients with stage C colon cancer who had undergone complete resection of the primary tumor. The patients were equally randomized to one of two arms: capecitabine (1250 mg/m2 twice daily for 14 days followed by seven days rest, repeated every 21 days for eight cycles) or bolus 5-FU/LV (Mayo Clinic regimen).

At a median follow-up of 4.4 years, a non-inferiority analysis for the primary endpoint of DFS in the all randomized population showed capecitabine retained at least 75 percent of the active control effect of 5-FU/LV. The three-year DFS rates for capecitabine and 5-FU/LV were 66 percent and 63 percent, respectively (hazard ratio 0.87, 95 percent CI: 0.76-1.00; test for difference: p = 0.055). No statistical difference in overall survival was shown between the treatment arms in the all randomized population (hazard ratio 0.88, 95 percent CI: 0.74-1.05; p = 0.17).

The incidence of grade 3 or 4 adverse events was 36 percent on the capecitabine arm and 35 percent on the 5-FU/LV arm. The most common capecitabine toxicities (diarrhea, stomatitis, nausea, and palmar-plantar erythrodysesthesia) are described in the current label, and in 93 percent of cases were reversible within 30 days. The incidence of febrile neutropenia or neutropenic sepsis was less than 1 percent.

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.

Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. Adjuvant therapy may include chemotherapy, radiation therapy, hormone therapy, targeted therapy, or biological therapy.

An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse effects do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe. Also called adverse event.

A single dose of drug usually injected into a blood vessel over a short period of time. Also called bolus infusion.

In clinical trials, an event or outcome that can be measured objectively to determine whether the intervention being studied is beneficial. The endpoints of a clinical trial are usually included in the study objectives. Some examples of endpoints are survival, improvements in quality of life, relief of symptoms, and disappearance of the tumor.

One of a group of substances used to treat cancer. A fluoropyrimidine is a type of antimetabolite. Examples are capecitabine, floxuridine, and fluorouracil (5-FU).

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.

A statistics term. The middle value in a set of measurements.

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 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.

Removed by surgery.

Describes a mathematical measure of difference between groups. The difference is said to be statistically significant if it is greater than what might be expected to happen by chance alone. Also called significant.