What is the dose for adjuvant single agent Capecitabine (Xeloda)?

From the Guidelines

The recommended dose for adjuvant single agent capecitabine in the treatment of cancer is 1000 mg/m² given orally twice daily (morning and evening, for a total daily dose of 2000 mg/m²) for 14 days, followed by a 7-day rest period, as this dose has been established in European studies and may need to be adjusted for North American patients due to potential increased toxicity 1.

Key Considerations

• The dose of capecitabine may need to be reduced in North American patients due to increased toxicity compared to European patients, with potential adjustments to 75% or 50% of the starting dose 1.
• Capecitabine should be taken with water within 30 minutes after a meal to enhance absorption.
• Common side effects include hand-foot syndrome, diarrhea, nausea, vomiting, and fatigue.
• Regular monitoring of complete blood counts, liver function, and renal function is recommended during treatment.

Mechanism and Administration

• Capecitabine works as a prodrug that is converted to 5-fluorouracil in tumor tissue, providing targeted cytotoxicity while potentially reducing systemic toxicity compared to intravenous 5-FU administration.
• The 21-day cycle is typically repeated for a total of 8 cycles (6 months of treatment).

Important Notes

• Patients with diminished creatinine clearance may require dose modification of capecitabine 1.
• The use of single-agent capecitabine after progression on a fluoropyrimidine-containing regimen has been shown to be ineffective; therefore, this is not recommended 1.

From the FDA Drug Label

The recommended dose of XELODA is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles. Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6 months, ie, XELODA 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks)

The dose for adjuvant single agent Capecitabine (Xeloda) is 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks) 2 2.

• Key points:
  • Dose: 1250 mg/m2
  • Administration: orally twice daily
  • Duration: 2 weeks
  • Rest period: 1 week
  • Total cycles: 8 cycles
  • Total duration: 24 weeks

From the Research

Adjuvant Single Agent Capecitabine (Xeloda) Dose

• The dose for adjuvant single agent Capecitabine (Xeloda) is not explicitly stated in the provided studies as "adjuvant" typically refers to treatment given after primary therapy to reduce the risk of cancer recurrence, and the studies focus on metastatic breast cancer treatment.
• However, the studies provide information on the dosing schedules of capecitabine in the treatment of metastatic breast cancer, which may be relevant:
  • A study published in 2007 3 used a dose of 1250 mg/m2 twice daily for 14 days followed by 7 days of rest, but also explored a reduced dose of 1000 mg/m2 twice daily with a better therapeutic profile and encouraging efficacy.
  • Another study from 2004 4 used a fixed daily dose of 1500 or 2000 mg of capecitabine, administered continuously for an open-ended period, with a median of 3 months.
  • A 2009 review 5 discussed the common starting dose of capecitabine as between 1000-1250 mg/m2, usually administered twice daily for 14 days followed by 7 days rest, but highlighted the need for individualized dosing due to interpatient differences.
  • A 2020 study 6 compared the standard dosing of capecitabine (1000 mg/m2 orally, twice daily on days 1-14 of a 21-day cycle) to biweekly dosing (1000 mg/m2 orally, twice daily on days 1-7 and 15-21 of a 28-day cycle), finding similar efficacy and fewer dose reductions with the biweekly schedule.
  • A 2011 study 7 used a dose of 1000 mg/m2 twice daily, days 1-14, in combination with mitomycin C as first-line treatment in patients with metastatic breast cancer.

Dosing Schedules

• The dosing schedules of capecitabine vary across the studies, with some using a standard 21-day cycle and others using a biweekly or continuous schedule.
• The choice of dosing schedule may depend on individual patient factors, such as tolerance and efficacy, as well as the specific treatment regimen and goals.