Study of low-dose capecitabine monotherapy for metastatic breast cancer.

Background: Capecitabine is an established therapy for metastatic breast cancer. In Japan, a 4 weekly regimen is often used, but data for this schedule in the first-line setting are lacking.

Methods: Metastatic breast cancer patients who had received no chemotherapy for recurrent disease received capecitabine 825 mg/m(2) twice daily, on days 1-21 of a 28-day cycle until disease progression or unacceptable toxicity. The primary endpoint was response rate.

Results: In 33 eligible patients, median age was 53 years (range 27-73). Prior adjuvant therapy included an anthracycline in 90% and a taxane in 40%. The response rate was 18%; a further 24% had stable disease for >or=6 months. Median progression-free and overall survival were 6.9 and 24.8 months, respectively. The only grade 3 events were neutropenia (6%) and hand-foot syndrome (15%).

Conclusions: These preliminary results confirm previous data showing that a lower capecitabine dose is an active and well-tolerated first-line therapy for metastatic breast cancer.