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Capecitabine (brand name: Xeloda®) is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. It is enzymatically converted to fluorouracil in the body, where it inhibits DNA synthesis and slows growth of tumor tissue. more...



Capecitabine is FDA-approved for:

Metastatic Colorectal Cancer

  • Used as first-line monotherapy, if appropriate.

Metastatic Breast Cancer

  • Used in combination with docetaxel, after failure of anthracycline-based treatment.
  • Used as monotherapy, if the patient has failed paclitaxel-based treatment, and if anthracycline-based treatment has either failed or cannot be continued for other reasons (i.e., the patient has already received the maximum lifetime dose of an anthracycline).


The usual starting dose is 2,500 mg/m2/day in two divided doses, 12 hours apart. One cycle includes two weeks of treatment followed by one week without treatment. Cycles can be repeated every three weeks.

Dose Adjustments

  • For mild renal dysfunction (creatinine clearance 30-50 mL/min), it is recommended to reduce dose by 25%.
  • For severe renal dysfunction (creatinine clearance <30 mL/min), treatment is not recommended.
  • There is no recommendation for hepatic dysfunction.
  • For elderly patients, lower doses may be required due to higher incidences of serious adverse reactions.


Take orally with water, within 30 minutes after a meal.

Potential Adverse Reactions (Major)

  • Cardiovascular: EKG changes, myocardial infarction, angina (these may be more common in patients with pre-existing coronary artery disease)
  • Dermatological: Hand-foot syndrome (numbness, tingling, pain, redness, or blistering of the palms of the hands and soles of the feet)
  • Gastrointestinal: Diarrhea (sometimes severe), nausea, stomatitis
  • Hematological: Neutropenia, anemia, thrombocytopenia
  • Hepatic: Hyperbilirubinemia

Drug Interactions

  • Capecitabine may interact with warfarin and increase bleeding risk. It is recommended to watch coagulation levels (INR) closely and adjust warfarin doses appropriately.
  • Capecitabine may inhibit cytochrome CYP2C9 enzyme, and therefore increase levels of substrates such as phenytoin. It is recommended to monitor phenytoin levels in patients taking both medications. Other substrates of CYP2C9 may also be affected. Evaluate according to clinical judgment.
  • Much as fluorouracil, the concomitant use of leucovorin may increase both the efficacy and the toxicity of capecitabine.

Pregnancy / Lactation Information

  • Capecitabine is pregnancy category D. Women of childbearing potential are advised to avoid becoming pregnant while using capecitabine.
  • Significant amounts of capecitabine may be excreted into the breast milk. It is recommended to discontinue nursing while using capecitabine.


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Oral Chemotherapy Xeloda Shown to Extend Survival for Patients with Pancreatic Cancer
From PR Newswire, 11/2/05

- Data show significant survival benefit in fighting aggressive cancer -

NUTLEY, N.J., Nov. 2 /PRNewswire/ -- The interim analysis of one of the largest phase III studies investigating the first-line treatment of advanced pancreatic cancer revealed that adding the oral chemotherapy pill Xeloda (capecitabine) to standard chemotherapy (gemcitabine) in the trial significantly extended patient survival. The study showed that after a year, one patient out of every four was still alive when treated with Xeloda plus standard chemotherapy, compared to one in five taking standard chemotherapy alone. These findings were unveiled today at the European Cancer Conference (ECCO) in Paris.

The American Cancer Society estimates that more than 32,000 Americans will be diagnosed with cancer of the pancreas during 2005. The 5-year relative survival rate for the disease is only 4% and few effective treatment options exist for the disease.

"These data show there are new possibilities for pancreatic cancer patients who, in general, have a short life expectancy once diagnosed," said Julie Fleshman, JD, MBA, President & CEO of Pancreatic Cancer Action Network (PanCAN). "Because pancreatic cancer is one of the most aggressive forms of cancers, it is even more critical to discover and offer these patients more treatment options."

About the Study

This randomized study, designed by Cancer Research UK and funded in part by Roche, compared the survival of patients on a combination of gemcitabine and Xeloda with the survival of patients on gemcitabine monotherapy. Patients (n=533) were previously untreated and had locally advanced or metastatic pancreatic cancer. Patients receiving the combination therapy of gemcitabine and capcitabine lived significantly longer than those with standard therapy alone (median survival 7.4 vs. 6 months, HR= 0.80). A higher percentage of patients were alive at 12 months in the group treated with Xeloda plus gemcitabine, compared to those treated with gemcitabine alone (26% v 19%). The most common Grade 3-4 adverse events (equal to or greater than two percent) in the gemcitabine-capecitabine (GEM-CAP) combination arm of the study include neutropenia, increased white blood cell count, platelets, fatigue and hand/foot syndrome. The most common adverse events in the GEM arm alone included increased white blood cell count, neutropenia, platelets, hemoglobin, fatigue and nausea and vomitting.

"Some of my patients with advanced, inoperable pancreatic cancer are seeing improvement in their tumor size by adding Xeloda to their traditional chemotherapy," said lead investigator, Professor David Cunningham, Royal Marsden Hospital, London. "This is the first time that adding another cytotoxic drug to gemcitabine has improved the outcome for patients with inoperable pancreatic cancer and the trial results are, therefore, an important milestone."

About Xeloda

Xeloda is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Xeloda is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.

For treatment of metastatic breast cancer, Xeloda is indicated in combination with docetaxel after failure of prior anthracyline-containing chemotherapy. Xeloda monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalence.

About Roche - More Than a Century in the U.S. and the World

Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of the world's leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is one of the world's leaders in diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on many fronts to improve people's health and quality of life. Roche employs roughly 65,000 people in 150 countries, including approximately 15,000 in the United States.

Roche's U.S. operations celebrate their American Centennial in 2005. In another milestone this year, Roche was named in January to Fortune magazine's list of Best Companies to Work for in America. One of an increasingly rare breed of major healthcare companies that still bear their original name, Roche today has more than a dozen U.S. sites located in California, Colorado, Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai. Roche's Pharmaceuticals Division offers a portfolio of leading medicines in therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation, dermatology and influenza. Roche's Diagnostics Division supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our worldwide and U.S. websites (Global: and U.S.:

About PanCAN

The Pancreatic Cancer Action Network, Inc. (PanCAN) is a 501(c)(3) nonprofit organization founded in 1999 and chartered as the first, national public-benefit organization for the pancreatic cancer community. The organization works to focus national attention on the need to find a cure for pancreatic cancer, and provides patient services to families and patients around the country, as well as public and professional education embracing the urgent need for more research, effective treatments, prevention programs and early detection methods. PanCAN currently has volunteers and members throughout the United States and around the world. Visit to obtain more information, e-mail, or call 1-877-272-6226.

the Key Statistics About Cancer of the Pancreas? cs_for_pancreatic_cancer_34.asp?sitearea=

2. Ibid.

CONTACT: Ginny Valenze, Roche, Office: +1-973-562-2783, Cell: +1-973-943-9219,; Christine Ennis, Manning Selvage & Lee, Office: +1-212-468-3986, Cell: +1-917-620-5291,

Web site:

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COPYRIGHT 2005 Gale Group

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