An open-label, multicenter study of outpatient capecitabine monotherapy in 631 patients with pretreated advanced breast cancer

Background: Phase II/III trials have shown that capecitabine is an active, well-tolerated therapy for metastatic breast cancer (MBC). We report clinical findings from an expanded access program enabling patients ineligible for investigative trials to receive capecitabine before its approval and availability. Methods: Patients pretreated with at least two chemotherapy regimens, including a taxane, for MBC received oral capecitabine until disease progression or unacceptable toxicity. Results: Six hundred and thirty-one patients received capecitabine (mean duration 3.8 months, range 0.1-24.7 months). The most common treatment-related grade 3/4 toxicities were diarrhea (9%) and hand-foot syndrome (8%). Grade 3/4 alopecia was absent and grade 3/4 myelosuppression was rare. Dose was modified in 172 patients (27%). Objective response rate in 349 evaluable patients was 35%. Median time to progression (n = 604) was 6.6 months (95% confidence interval, CI, 5.6-7.6) and median overall survival (n = 569) was 10.0 months (95% CI, 8.5-15.3). Conclusions: Our findings in a cohort of patients with pretreated progressive breast cancer confirm the high efficacy and tolerability of outpatient capecitabine.