• Breast Cancer Disease Site Group. Tomiak E, Verma S, Trudeau M, Robinson P. Capecitabine in stage IV breast cancer [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2003 Nov 26 [online update]. 17 p. (Practice guideline report; no. 1-16). [31 references]

• In selected patients (e.g., those with good performance status, less than 70 years of age, and with no other major comorbidities) who are anthracycline-resistant or who have previously received an anthracycline as adjuvant therapy, the combination of docetaxel and capecitabine is an appropriate therapeutic option.
• If docetaxel and capecitabine are used in combination, the recommended starting dose for most patients is 950 mg/m² twice daily of capecitabine (75% of full dose) on days 1 to 14 plus docetaxel 75 mg/m² intravenously on day 1 of a 21-day cycle.
• In patients who have been pretreated with anthracyclines and/or taxanes, capecitabine alone (1,250 mg/m² twice daily, for 21 days) is a reasonable treatment option.
• There is insufficient evidence for the use of capecitabine as a first-line chemotherapy in metastatic breast cancer.
• Warnings:
  • Patients receiving concomitant capecitabine and coumarin-derivative therapy should have their anticoagulant response monitored, as coagulant response time is significantly increased in patients stabilized on anticoagulants at the time of capecitabine introduction.
  • In patients with renal impairment, capecitabine therapy can increase systemic exposure to alpha-fluoro-beta-alanine (FBAL) and 5’-deoxy-5-fluorouridine (5’- DFUR). Specifically, capecitabine is contraindicated in patients with severe renal impairment (calculated creatinine clearance <30 mL/min) and should be reduced to a starting daily dose of 1,900 mg/m2 for patients with moderate renal impairment (calculated creatinine clearance 30-50 mL/min). Patients with mild renal impairment should be closely monitored.

None provided

The references are supported by phase II and III randomized trials.

• Breast Cancer Disease Site Group. Tomiak E, Verma S, Trudeau M, Robinson P. Capecitabine in stage IV breast cancer [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2003 Nov 26 [online update]. 17 p. (Practice guideline report; no. 1-16). [31 references]

Not applicable: The guideline was not adapted from another source.

2003 Nov 26

Program in Evidence-based Care - State/Local Government Agency [Non-U.S.]

The Practice Guidelines Initiative (PGI) is the main project of the Program in Evidence-based Care (PEBC), a Province of Ontario initiative sponsored by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.

Cancer Care Ontario, Ontario Ministry of Health and Long-Term Care

Breast Cancer Disease Site Group

Members of the Breast Cancer Disease Site Group disclosed potential conflict of interest information.

None available

This NGC summary was completed by ECRI on April 19, 2004. The information was verified by the guideline developer on April 29, 2004.