Proven Efficacy

Metastatic Colorectal Cancer (mCRC)
  • Superior response rates and equivalent survival compared to 5-FU/LV in first-line mCRC1,2,3
 
Adjuvant Stage III (Dukes' C) Colon Cancer
  • 4.1% improvement in 5-year disease free survival (DFS) compared to 5-FU/LV
 
Metastatic Breast Cancer (mBC)
  • Proven efficacy regardless of HER2 status4
  • 25.6% response rate in anthracycline- and taxane-pretreated mBC patients5-8
  • XELODA plus docetaxel delivers rapid response and superior survival9
 

Manageable Safety Profile

Adverse Events Are Manageable and, in Most Cases, Reversible
  • Dose modification does not appear to compromise efficacy across indications9,13,14,15
 
Preferential Activation and prolonged Exposure—A Unique Cytotoxic Option10-12
  • Learn more about XELODA's preferential activation and prolonged cytotoxic exposure
 
  • Click here to view a video describing XELODA's unique mechanism of action (MOA).
 
 
 
REFERENCES
1. Twelves C, Scheithauer W, McKendrick J, et al. Capecitabine versus 5-FU/LV in stage III colon cancer: updated 5-year efficacy data from X-ACT trial and preliminary analysis of relationship between hand-foot syndrome (HFS) and efficacy. Presented at: American Society of Clinical Oncology Annual Meeting; May 30-June 3, 2008; Chicago, Illinois (Abstract 274).
2. Van Cutsem E, Hoff PM, Harper P, et al. Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: results of a large phase III study. J Clin Oncol. 2001;19(21):4097-4106.
3. Van Cutsem E, Hoff PM, Harper P, et al. Oral capecitabine vs intravenous 5-flourouracil and leucovorin: integrated efficacy data and novel analyses from two large, radomised, phase III trials. Br J Cancer. 2004;90:1190-1197.
4. Tykerb [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2007.
5. Zelek L, Barthier S, Riofrio M, et al. Weekly vinorelbine is an effective palliative regimen after failure with anthracyclines and taxanes in metastatic breast carcinoma. Cancer 2001;92(9):2267-2272.
6. Blum JL, Savin MA, Edelman G, et al. Long-term disease control in taxane-refractory metastatic breast cancer treated with nab paclitaxel [abstract] J Clin Oncol. 2004;22(July 15 suppl):543.
7. Valero V, Jones SE, Von Hoff DD, et al. A phase II study of docetaxel in patients with paclitaxel-resistant metastatic breast cancer. J Clin Oncol. 1998;6(10)3362-3368.
8. Modi S, Currie VE, Seidman AD, et al. A phase II trial of gemcitabine in patients with metastatic breast cancer previously treated with an anthracycline and taxane. Clin Breast Cancer. 2005;6(1):55-60.
9. O'Shaughnessy JA. Superior survival with the combination of docetaxel and capecitabine compared to docetaxel alone in anthracycline-pretreated metastatic breast cancer patients. Am J Oncol Rev. 2002;1(5):280-285.
10. Schuller J, Cassidy J, Dumont E, et al. Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol. 200;45:291-297.
11. Miwa M, Ura M, Nishida M, et al. Design of a novel oral fluoropyrimidine, carbamate, capecitabine, which generates 5-fluorouracil selectively in tumors by enzymes concentrated in human liver and cancer tissue. Eur J Cancer. 1998;34:1274-1281.
12. Thomas DM, Zalcberg JR. 5-fluorouracil: a pharmacological paradigm in the use of cytotoxics. Clin Exp Pharmacol Physiol. 1998;25:887-895.
13. Data on file (Ref. 111-036), Hoffmann-La Roche Inc., Nutley, NJ 07110
14. Cassidy J, Twelves C, Van Cutsem Em, et al. First-line oral capecitabine therapy in metastatic colorectal cancer: a favorable safety profile compared with intravenous 5-fluorouracil/leucovorin. Ann Oncol. 2002;13;566-575.
15. O'Shaughnessy J, Miles D, Vukelja S, et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol. 2002;20(12):2812-2823.
  
Indications
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. XELODA was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Although neither XELODA nor combination chemotherapy prolongs overall survival (OS), combination chemotherapy has been demonstrated to improve disease-free survival compared to 5-FU/LV. Physicians should consider these results when prescribing single-agent XELODA in the adjuvant treatment of Dukes' C colon cancer.
 
XELODA is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with XELODA monotherapy. Use of XELODA instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.
 
XELODA monotherapy is 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, eg, patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.
 
XELODA in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
 
Important Safety Information
WARNING
For patients receiving XELODA and warfarin concomitantly, frequent monitoring of INR or prothrombin time (PT) is recommended. A clinically important drug interaction between XELODA and warfarin has been demonstrated. Altered coagulation parameters and/or bleeding and death have been reported. Clinically significant increases in PT and INR have been observed within days to months after starting XELODA, and infrequently within one month of stopping XELODA. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.

 
Adverse Events
In XELODA monotherapy for colon cancer in the adjuvant setting, the most common adverse events for all grades (>10%) in patients receiving either XELODA or 5-FU/LV (%;%) were hand-foot syndrome (60;9), diarrhea (47;65), nausea (34;47), stomatitis (22;60), fatigue (16;16), lethargy (16;15), vomiting (15;21), abdominal pain (14;16), asthenia (10;10), anorexia (9;11), constipation (9;11), and alopecia (6;22). Grade 3/4 adverse events (>5%) in patients receiving either XELODA or 5-FU/LV were hand-foot syndrome (17;<1), diarrhea (12;14), stomatitis (2;14), and neutropenia (<1;5).
 
In XELODA monotherapy for metastatic colorectal cancer, the most common adverse events (>10%) in patients receiving either XELODA or 5-FU/LV (%;%) were anemia (80;79), diarrhea (55;61), hand-foot syndrome (54;6), hyperbilirubinemia (48;17), nausea (43;51), fatigue/weakness (42;46), abdominal pain (35;31), dermatitis (27;26), vomiting (27;30), appetite decrease (26;31), stomatitis (25;62), pyrexia (18;21), edema (15;9), constipation (14;17), dyspnea (14;10), neutropenia (13;46), pain (12;10), back pain (10;9), headache (10;7), gastrointestinal motility disorder (10;7), oral discomfort (10;10), upper GI inflammatory disorders (8;10), peripheral sensory neuropathy (10;4), taste disturbance (6;11), and eye irritation (13;10). Grade 3/4 adverse events (>5%) in patients receiving either XELODA or 5-FU/LV were hyperbilirubinemia (23;6), hand-foot syndrome (17;1), diarrhea (15;12), abdominal pain (10;5), vomiting (5;5), ileus (5;3), stomatitis (3;15), and neutropenia (3;21).
 
In XELODA monotherapy for metastatic breast cancer, the most common adverse events (>10%) in patients receiving XELODA (%) were lymphopenia (94), anemia (72), diarrhea (57), hand-foot syndrome (57), nausea (53), fatigue (41), dermatitis (37), vomiting (37), neutropenia (26), stomatitis (24), thrombocytopenia (24), anorexia (23), hyperbilirubinemia (22), paresthesia (21), abdominal pain (20), constipation (15), eye irritation (15), and pyrexia (12). Grade 3/4 adverse events (>5%) in patients receiving XELODA were lymphopenia (59), diarrhea (15), hand-foot syndrome (11), hyperbilirubinemia (11), fatigue (8), stomatitis (7), and dehydration (5).
 
In XELODA combination therapy (XELODA plus docetaxel) for breast cancer, the most common adverse events (>10%) in patients receiving either XELODA plus docetaxel or docetaxel alone (%;%) were lymphocytopenia (99;98), leukopenia (91;88), neutropenia/granulocytopenia (86;87), anemia (80;83), diarrhea (67;48), stomatitis (67;43), hand-foot syndrome (63;8), nausea (45;36), alopecia (41;42), thrombocytopenia (41;23), vomiting (35;24), edema (33;34), abdominal pain (30;24), pyrexia (28;34), asthenia (26;25), fatigue (22;27), constipation (20;18), hyperbilirubinemia (20;6), neutropenic fever (16;21), taste disturbance (16;14), weakness (16;11), arthralgia (15;24), headache (15;15), myalgia (15;25), dyspnea (14;16), dyspepsia (14;8), nail disorder (14;15), anorexia (13;11), cough (13;22), pain in limb (13;13), back pain (12;11), dizziness (12;8), lacrimation increase (12;7), paresthesia (12;16), sore throat (12;11), appetite decrease (10;5), dehydration (10;7), bone pain (8;10), dermatitis (8;11), insomnia (8;10), and peripheral neuropathy (6;10). Grade 3/4 adverse events (>5%) in patients receiving XELODA plus docetaxel or docetaxel alone (%;%) were lymphocytopenia (89;84), leukopenia (61;75), neutropenia/granulocytopenia (69;76), hand-foot syndrome (24;1), stomatitis (18;5), neutropenic fever (16;21), diarrhea (15;6), anemia (10;6), hyperbilirubinemia (9;4), nausea (7;2), alopecia (6;7), vomiting (5;2), asthenia (5;6), and fatigue (4;6).
 
Contraindications and Warnings
  • XELODA is contraindicated in patients who have a known hypersensitivity to capecitabine or to any of its components or to 5-fluorouracil. XELODA is contraindicated in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • XELODA is contraindicated in patients with severe renal impairment. Patients with mild or moderate renal impairment at baseline should be carefully monitored for adverse events. Patients with moderate renal impairment at baseline require a reduced starting dose.
  • XELODA can induce diarrhea, sometimes severe. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.
     
    If an adverse event of grade 2, 3, or 4 occurs (eg, diarrhea), administration of XELODA should be immediately interrupted until the adverse event resolves or decreases in intensity to grade 1. Following a grade 2 reoccurrence of the adverse event or occurrence of any other grade 3 or 4 adverse event, subsequent doses of XELODA should be decreased. Please consult XELODA Prescribing Information (DOSAGE AND ADMINISTRATION) for recommended dose modifications for management of adverse events.
     
  • Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with XELODA. Men should use birth control while taking XELODA. Women should not nurse when receiving XELODA therapy.
Precautions
  • The addition of leucovorin to XELODA is not recommended. There was no apparent advantage in response rate by adding leucovorin to XELODA; however, toxicity was increased.
  • Cardiotoxicity has been observed with XELODA, including myocardial infarction/ischemia, angina, dysrhythmias, cardiac arrest, cardiac failure, sudden death, electrocardiographic changes, and cardiomyopathy. These adverse events may be more common in patients with a prior history of coronary artery disease.
  • Care should be exercised when XELODA is coadministered with CYP2C9 substrates.
  • The level of phenytoin should be carefully monitored in patients taking XELODA and the dose of phenytoin may need to be reduced.
  • If drug-related grade 2 to 4 elevations in bilirubin occur, administration of XELODA should be immediately interrupted until the hyperbilirubinemia resolves or decreases in intensity to grade 1.

Please see complete XELODA Prescribing Information.
 
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